<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03271307</url>
  </required_header>
  <id_info>
    <org_study_id>17-000109</org_study_id>
    <nct_id>NCT03271307</nct_id>
  </id_info>
  <brief_title>Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners</brief_title>
  <official_title>Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Partners in Hope</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Right to Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Malawi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV&#xD;
      self-testing strategies compared to standard of care among clients in outpatient departments&#xD;
      (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).&#xD;
&#xD;
      Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in&#xD;
      Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility&#xD;
      and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.&#xD;
&#xD;
      Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi.&#xD;
      We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and&#xD;
      cost-effectiveness of index HIVST among partners of HIV-positive clients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of&#xD;
      HIVST strategies among adults in Malawi.&#xD;
&#xD;
      Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites&#xD;
      in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1)&#xD;
      standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard&#xD;
      of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services.&#xD;
      The standard of care arm will receive no intervention. The optimized standard of care arm&#xD;
      will receive training and support for implementing the Malawi guidelines for PITC and morning&#xD;
      testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and&#xD;
      distribution, followed by uses of HIVST and private spaces for kit interpretation before&#xD;
      receiving routine OPD services. Participants may present their self-test results to their&#xD;
      provider, who will refer them for confirmatory HIV testing and routine ART initiation (if&#xD;
      positive). That same day, participants from all arms will complete a brief survey upon&#xD;
      exiting the clinic. Survey and medical record data will be compared across arms to determine&#xD;
      whether facility HIVST is superior in regard to number of individuals tested for HIV,&#xD;
      cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for&#xD;
      those who identify as HIV-positive.&#xD;
&#xD;
      Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners&#xD;
      of HIV-positive clients. It will be an unblinded individually-randomized trial and include&#xD;
      two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard&#xD;
      of care arm will receive no intervention for partner notification and referral. HIV-positive&#xD;
      clients in the HIVST arm will receive a HIVST demonstration and distribution, with&#xD;
      instructions to give the HIVST kit to their sexual partner. Participants will be given one&#xD;
      HIVST for each of their sexual partners who has an unknown HIV status or who tested&#xD;
      HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index&#xD;
      clients) will be given instructions on how their partner can complete the self-test and how&#xD;
      to refer their partner(s) to care if they receive a positive result from the self-test. All&#xD;
      participants (standard of care and HIVST arms) will complete a brief survey at the beginning&#xD;
      of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes.&#xD;
      Medical chart reviews will be conducted for all partners reported to test HIV-positive in&#xD;
      order to assess ART initiation rates. Survey and medical record data will be compared across&#xD;
      arms to determine whether index HIVST is superior in regard to number of partners tested for&#xD;
      HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for&#xD;
      those who identify as HIV-positive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">January 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aim 1: Proportion of Adult OPD Clients Tested for HIV</measure>
    <time_frame>1 day</time_frame>
    <description>Same day HIV testing among OPD clients, measured by self-reports from OPD clients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aim 2: Proportion of Sexual Partners Tested for HIV</measure>
    <time_frame>4-weeks</time_frame>
    <description>HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aim 1: HIV-positivity Rate</measure>
    <time_frame>Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)</time_frame>
    <description>HIV-positivity rate among OPD clients, measured by self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 1: ART Initiation Among OPD Clients Tested HIV-positive</measure>
    <time_frame>3 months</time_frame>
    <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 1: Presence of Non-serious Adverse Events</measure>
    <time_frame>as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)</time_frame>
    <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 1: Cost Per Person Initiated ART</measure>
    <time_frame>3 months</time_frame>
    <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV</measure>
    <time_frame>4-weeks</time_frame>
    <description>HIV-positivity rate measured by secondary report by the HIV-positive client</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive</measure>
    <time_frame>3 months</time_frame>
    <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 2: Presence of Non-serious Adverse Events</measure>
    <time_frame>4-weeks</time_frame>
    <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 2: Cost Per Person Tested HIV-Positive</measure>
    <time_frame>1 month</time_frame>
    <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 2: Cost Per Person Initiated ART</measure>
    <time_frame>3 month</time_frame>
    <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">6369</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>AIm 1: Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 1: Optimized standard of care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 1: Facility HIVST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 2: Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 2: Index HIVST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Optimized PITC</intervention_name>
    <description>Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
    <arm_group_label>Aim 1: Optimized standard of care</arm_group_label>
    <other_name>Optimized standard of care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Facility HIVST</intervention_name>
    <description>HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
    <arm_group_label>Aim 1: Facility HIVST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Index HIVST</intervention_name>
    <description>HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
    <arm_group_label>Aim 2: Index HIVST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  15 years or older&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Being seen for OPD services at the time of the study (Aim 1)&#xD;
&#xD;
          -  HIV-positive (Aim 2)&#xD;
&#xD;
          -  Have at least one sex partner in the catchment area with an unknown HIV status at the&#xD;
             time of study enrollment (Aim 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in the INTERVAL study&#xD;
&#xD;
          -  Guardians attending clinics with OPD clients (Aim 1)&#xD;
&#xD;
          -  History of intimate partner violence in the past 12 months (Aim 2)&#xD;
&#xD;
          -  Fear of intimate partner violence as a consequence of participating in the study (Aim&#xD;
             2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Dovel, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Partners in Hope</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>May 15, 2019</results_first_submitted>
  <results_first_submitted_qc>November 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2020</results_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Kathryn L. Dovel, PhD</investigator_full_name>
    <investigator_title>Adjunct Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>self-test</keyword>
  <keyword>testing</keyword>
  <keyword>cost-effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03271307/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited during routine health services at participating facilities. For Aim 1, participants were recruited from September 18, 2017 - February 19, 2018. For Aim 2, participants were recruited from March 21, 2018 - June 13, 2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>AIm 1: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
        </group>
        <group group_id="P2">
          <title>Aim 1: Optimized Standard of Care</title>
          <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
        </group>
        <group group_id="P3">
          <title>Aim 1: Facility HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
        <group group_id="P4">
          <title>Aim 2: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
        </group>
        <group group_id="P5">
          <title>Aim 2: Index HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1951"/>
                <participants group_id="P2" count="1837"/>
                <participants group_id="P3" count="2097"/>
                <participants group_id="P4" count="135"/>
                <participants group_id="P5" count="349"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1951"/>
                <participants group_id="P2" count="1837"/>
                <participants group_id="P3" count="2097"/>
                <participants group_id="P4" count="107"/>
                <participants group_id="P5" count="258"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="91"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="91"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AIm 1: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
        </group>
        <group group_id="B2">
          <title>Aim 1: Optimized Standard of Care</title>
          <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
        </group>
        <group group_id="B3">
          <title>Aim 1: Facility HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
        <group group_id="B4">
          <title>Aim 2: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
        </group>
        <group group_id="B5">
          <title>Aim 2: Index HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1951"/>
            <count group_id="B2" value="1837"/>
            <count group_id="B3" value="2097"/>
            <count group_id="B4" value="135"/>
            <count group_id="B5" value="349"/>
            <count group_id="B6" value="6369"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="280"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="264"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="778"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1594"/>
                    <measurement group_id="B2" value="1543"/>
                    <measurement group_id="B3" value="1800"/>
                    <measurement group_id="B4" value="126"/>
                    <measurement group_id="B5" value="337"/>
                    <measurement group_id="B6" value="5400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" lower_limit="26" upper_limit="35"/>
                    <measurement group_id="B2" value="36" lower_limit="25" upper_limit="48"/>
                    <measurement group_id="B3" value="35" lower_limit="28" upper_limit="44"/>
                    <measurement group_id="B4" value="35" lower_limit="29" upper_limit="45"/>
                    <measurement group_id="B5" value="36" lower_limit="28" upper_limit="43"/>
                    <measurement group_id="B6" value="35" lower_limit="27" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1327"/>
                    <measurement group_id="B2" value="1002"/>
                    <measurement group_id="B3" value="1304"/>
                    <measurement group_id="B4" value="105"/>
                    <measurement group_id="B5" value="266"/>
                    <measurement group_id="B6" value="4004"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="624"/>
                    <measurement group_id="B2" value="835"/>
                    <measurement group_id="B3" value="793"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="83"/>
                    <measurement group_id="B6" value="2365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1951"/>
                    <measurement group_id="B2" value="1837"/>
                    <measurement group_id="B3" value="2097"/>
                    <measurement group_id="B4" value="135"/>
                    <measurement group_id="B5" value="349"/>
                    <measurement group_id="B6" value="6369"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Malawi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1951"/>
                    <measurement group_id="B2" value="1837"/>
                    <measurement group_id="B3" value="2097"/>
                    <measurement group_id="B4" value="135"/>
                    <measurement group_id="B5" value="349"/>
                    <measurement group_id="B6" value="6369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tested for HIV ≥3months ago</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="625"/>
                    <measurement group_id="B2" value="508"/>
                    <measurement group_id="B3" value="320"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Aim 1: Proportion of Adult OPD Clients Tested for HIV</title>
        <description>Same day HIV testing among OPD clients, measured by self-reports from OPD clients</description>
        <time_frame>1 day</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 1: Proportion of Adult OPD Clients Tested for HIV</title>
          <description>Same day HIV testing among OPD clients, measured by self-reports from OPD clients</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1951"/>
                <count group_id="O2" value="1837"/>
                <count group_id="O3" value="2097"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1951"/>
                    <measurement group_id="O2" value="1837"/>
                    <measurement group_id="O3" value="2097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Aim 2: Proportion of Sexual Partners Tested for HIV</title>
        <description>HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients</description>
        <time_frame>4-weeks</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: Proportion of Sexual Partners Tested for HIV</title>
          <description>HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="107"/>
                <count group_id="O5" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="107"/>
                    <measurement group_id="O5" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 1: HIV-positivity Rate</title>
        <description>HIV-positivity rate among OPD clients, measured by self-report</description>
        <time_frame>Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 1: HIV-positivity Rate</title>
          <description>HIV-positivity rate among OPD clients, measured by self-report</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1951"/>
                <count group_id="O2" value="1837"/>
                <count group_id="O3" value="2097"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1951"/>
                    <measurement group_id="O2" value="1837"/>
                    <measurement group_id="O3" value="2097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 1: ART Initiation Among OPD Clients Tested HIV-positive</title>
        <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
        <time_frame>3 months</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 1: ART Initiation Among OPD Clients Tested HIV-positive</title>
          <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1951"/>
                <count group_id="O2" value="1837"/>
                <count group_id="O3" value="2097"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1951"/>
                    <measurement group_id="O2" value="1837"/>
                    <measurement group_id="O3" value="2097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 1: Presence of Non-serious Adverse Events</title>
        <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.</description>
        <time_frame>as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 1: Presence of Non-serious Adverse Events</title>
          <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1951"/>
                <count group_id="O2" value="1837"/>
                <count group_id="O3" value="2097"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1951"/>
                    <measurement group_id="O2" value="1837"/>
                    <measurement group_id="O3" value="2097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 1: Cost Per Person Initiated ART</title>
        <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
        <time_frame>3 months</time_frame>
        <population>Total testing-related costs per person initiated on ART were calculated by study group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aim 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 1: Cost Per Person Initiated ART</title>
          <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
          <population>Total testing-related costs per person initiated on ART were calculated by study group.</population>
          <units>US dollar</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="248"/>
                <count group_id="O2" value="261"/>
                <count group_id="O3" value="1063"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.02" spread="NA">Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes</measurement>
                    <measurement group_id="O2" value="156.27" spread="NA">Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes</measurement>
                    <measurement group_id="O3" value="279.18" spread="NA">Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV</title>
        <description>HIV-positivity rate measured by secondary report by the HIV-positive client</description>
        <time_frame>4-weeks</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV</title>
          <description>HIV-positivity rate measured by secondary report by the HIV-positive client</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="107"/>
                <count group_id="O5" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="107"/>
                    <measurement group_id="O5" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive</title>
        <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
        <time_frame>3 months</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive</title>
          <description>ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="107"/>
                <count group_id="O5" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="107"/>
                    <measurement group_id="O5" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 2: Presence of Non-serious Adverse Events</title>
        <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client</description>
        <time_frame>4-weeks</time_frame>
        <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
        <group_list>
          <group group_id="O1">
            <title>AIm 1: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
          </group>
          <group group_id="O2">
            <title>Aim 1: Optimized Standard of Care</title>
            <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
          </group>
          <group group_id="O3">
            <title>Aim 1: Facility HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
          <group group_id="O4">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O5">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: Presence of Non-serious Adverse Events</title>
          <description>Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client</description>
          <population>Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="107"/>
                <count group_id="O5" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="107"/>
                    <measurement group_id="O5" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 2: Cost Per Person Tested HIV-Positive</title>
        <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
        <time_frame>1 month</time_frame>
        <population>Arms in Aim 1 not included in this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O2">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: Cost Per Person Tested HIV-Positive</title>
          <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
          <population>Arms in Aim 1 not included in this outcome.</population>
          <units>US dollar</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="NA">Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes</measurement>
                    <measurement group_id="O2" value="16.11" spread="NA">Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aim 2: Cost Per Person Initiated ART</title>
        <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
        <time_frame>3 month</time_frame>
        <population>Arms in Aim 1 not included in this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Aim 2: Standard of Care</title>
            <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
          </group>
          <group group_id="O2">
            <title>Aim 2: Index HIVST</title>
            <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
          </group>
        </group_list>
        <measure>
          <title>Aim 2: Cost Per Person Initiated ART</title>
          <description>Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.</description>
          <population>Arms in Aim 1 not included in this outcome</population>
          <units>US dollar</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.11" spread="NA">Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost</measurement>
                    <measurement group_id="O2" value="68.27" spread="NA">Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For Aim 1 (Facility-based HIVST at OPD), adverse events were collected the same day as study enrollment, intervention, and assessment of outcomes. For Aim 2 (Index HIVST), adverse events were collected 4-weeks after study enrollment and delivery of the intervention (HIVST).</time_frame>
      <desc>For Aim 1, adverse events included (1) coercion to test or share test results; and (2) unwanted status disclosure. Data were collected from follow-up surveys with OPD clients enrolled in the study.&#xD;
For Aim 2, adverse events included (1) coercion to test or share test results; (2) unwanted status disclosure; (3) intimate personal violence to the HIV-positive client; and (4) end of the romantic relationship. Data were collected from follow-up surveys with ART clients enrolled in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>AIm 1: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.</description>
        </group>
        <group group_id="E2">
          <title>Aim 1: Optimized Standard of Care</title>
          <description>Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.&#xD;
Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.</description>
        </group>
        <group group_id="E3">
          <title>Aim 1: Facility HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).&#xD;
Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
        <group group_id="E4">
          <title>Aim 2: Standard of Care</title>
          <description>Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.</description>
        </group>
        <group group_id="E5">
          <title>Aim 2: Index HIVST</title>
          <description>Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).&#xD;
Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1951"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1837"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2097"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1951"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1837"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2097"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1951"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1837"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2097"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Aim 2 data rely on secondary reports from ART clients regarding HIV testing and test results for their sexual partner. Secondary reports may be bias, however, are findings are similar to other HIVST studies.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kathryn Dovel</name_or_title>
      <organization>University of California Los Angeles</organization>
      <phone>7143303416</phone>
      <email>KDovel@mednet.ucla.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271307
org study id: 17-000109
nct id: NCT03271307
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV
      self-testing strategies compared to standard of care among clients in outpatient departments
      (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).

      Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in
      Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility
      and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.

      Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi.
      We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and
      cost-effectiveness of index HIVST among partners of HIV-positive clients.
The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of
      HIVST strategies among adults in Malawi.

      Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites
      in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1)
      standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard
      of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services.
      The standard of care arm will receive no intervention. The optimized standard of care arm
      will receive training and support for implementing the Malawi guidelines for PITC and morning
      testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and
      distribution, followed by uses of HIVST and private spaces for kit interpretation before
      receiving routine OPD services. Participants may present their self-test results to their
      provider, who will refer them for confirmatory HIV testing and routine ART initiation (if
      positive). That same day, participants from all arms will complete a brief survey upon
      exiting the clinic. Survey and medical record data will be compared across arms to determine
      whether facility HIVST is superior in regard to number of individuals tested for HIV,
      cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for
      those who identify as HIV-positive.

      Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners
      of HIV-positive clients. It will be an unblinded individually-randomized trial and include
      two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard
      of care arm will receive no intervention for partner notification and referral. HIV-positive
      clients in the HIVST arm will receive a HIVST demonstration and distribution, with
      instructions to give the HIVST kit to their sexual partner. Participants will be given one
      HIVST for each of their sexual partners who has an unknown HIV status or who tested
      HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index
      clients) will be given instructions on how their partner can complete the self-test and how
      to refer their partner(s) to care if they receive a positive result from the self-test. All
      participants (standard of care and HIVST arms) will complete a brief survey at the beginning
      of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes.
      Medical chart reviews will be conducted for all partners reported to test HIV-positive in
      order to assess ART initiation rates. Survey and medical record data will be compared across
      arms to determine whether index HIVST is superior in regard to number of partners tested for
      HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for
      those who identify as HIV-positive.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Aim 1: Proportion of Adult OPD Clients Tested for HIV
time frame: 1 day
description: Same day HIV testing among OPD clients, measured by self-reports from OPD clients
measure: Aim 2: Proportion of Sexual Partners Tested for HIV
time frame: 4-weeks
description: HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients
measure: Aim 1: HIV-positivity Rate
time frame: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)
description: HIV-positivity rate among OPD clients, measured by self-report
measure: Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
time frame: 3 months
description: ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
measure: Aim 1: Presence of Non-serious Adverse Events
time frame: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)
description: Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.
measure: Aim 1: Cost Per Person Initiated ART
time frame: 3 months
description: Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
measure: Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
time frame: 4-weeks
description: HIV-positivity rate measured by secondary report by the HIV-positive client
measure: Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
time frame: 3 months
description: ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
measure: Aim 2: Presence of Non-serious Adverse Events
time frame: 4-weeks
description: Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client
measure: Aim 2: Cost Per Person Tested HIV-Positive
time frame: 1 month
description: Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
measure: Aim 2: Cost Per Person Initiated ART
time frame: 3 month
description: Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
arm group label: AIm 1: Standard of care
arm group type: No Intervention
description: Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
arm group label: Aim 1: Optimized standard of care
arm group type: Experimental
description: Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.
arm group label: Aim 1: Facility HIVST
arm group type: Experimental
description: Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).
arm group label: Aim 2: Standard of care
arm group type: No Intervention
description: Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
arm group label: Aim 2: Index HIVST
arm group type: Experimental
description: Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).
intervention type: Behavioral
intervention name: Optimized PITC
description: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.
arm group label: Aim 1: Optimized standard of care
other name: Optimized standard of care
intervention type: Diagnostic Test
intervention name: Facility HIVST
description: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.
arm group label: Aim 1: Facility HIVST
intervention type: Diagnostic Test
intervention name: Index HIVST
description: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.
arm group label: Aim 2: Index HIVST
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn Dovel, PhD, MPH
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: Malawi
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Kathryn L. Dovel, PhD
investigator title: Adjunct Assistant Professor
mesh term: HIV Infections
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Aim 2 data rely on secondary reports from ART clients regarding HIV testing and test results for their sexual partner. Secondary reports may be bias, however, are findings are similar to other HIVST studies.
point of contact: 