<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/NCT02994329</url>
  </required_header>
  <id_info>
    <org_study_id>HIV-SELF 3IE</org_study_id>
    <nct_id>NCT02994329</nct_id>
  </id_info>
  <brief_title>Community-based Distribution of Oral HIV Self-testing Kits</brief_title>
  <official_title>Community-based Distribution of Oral HIV Self-testing Kits-A Pilot Intervention and Rapid Impact Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zambart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zambart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of&#xD;
      oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of&#xD;
      home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV&#xD;
      status among the general adult and adolescent population.&#xD;
&#xD;
      The primary outcome of the trial is the proportion of individuals who know their HIV status,&#xD;
      defined as a self-report of being HIV positive or accepting testing (standard or self&#xD;
      testing) from the CHW.&#xD;
&#xD;
      Embedded within the impact evaluation is a process evaluation that will explore the fidelity&#xD;
      of the implementation of the intervention and outputs of the intervention. Qualitative data&#xD;
      on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any&#xD;
      impacts on relationships (including between couples and with CHW) associated with use of&#xD;
      HIVST kits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial Purpose This cluster randomised trial will evaluate the impact of a pilot intervention&#xD;
      of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of&#xD;
      home-based rapid HIV testing, by community health workers (CHWs ) on knowledge of HIV status&#xD;
      among the general adult and adolescent population.&#xD;
&#xD;
      Aim The overall aim of this trial is to investigate whether the inclusion of HIVST as an&#xD;
      option for HIV testing, in addition to the offer of HIV testing with a finger-prick blood&#xD;
      sample, increases the uptake of an offer of home-based HIV-testing overall relative to an&#xD;
      offer of HIV testing with a finger-prick blood sample alone.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to&#xD;
           the offer of HIV testing with a finger-prick blood sample through CHW increases the&#xD;
           uptake of an offer of HIV-testing among specific sub-populations including men,&#xD;
           adolescents and individuals who have not previously tested relative to an offer of HIV&#xD;
           testing with a finger-prick blood sample alone.&#xD;
&#xD;
        2. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to&#xD;
           the offer of HIV testing with a finger-prick blood sample through CHW increases the&#xD;
           proportion of individuals' diagnosed HIV positive relative to an offer of HIV testing&#xD;
           with a finger-prick blood sample alone.&#xD;
&#xD;
        3. Measure linkage to HIV treatment and care, or prevention services when HIVST is included&#xD;
           as an option for HIV testing in addition to the offer of HIV testing with a finger-prick&#xD;
           blood sample through CHW and levels of couples-testing.&#xD;
&#xD;
      Trial Design This cluster randomised trial will randomise community health worker zones (66&#xD;
      in total) to either distribute oral HIVST kits in addition to the offer of finger-prick rapid&#xD;
      HIV testing (33 zones) or to offer finger-prick rapid HIV testing alone (33 zones). The trial&#xD;
      is nested within theHPTN071/PopART trial and the CHWs to be randomised all work in 4 of the&#xD;
      intervention sites of this study.&#xD;
&#xD;
      Trial location Four communities in the Copperbelt and Central province of Zambia have been&#xD;
      chosen to participate in this trial.&#xD;
&#xD;
      Trial Participants All adults and adolescents aged 16 years or older living in these&#xD;
      communities are eligible for participation if they consent to participate in the household&#xD;
      visit and are eligible for HIV testing (individuals aged 16 years or older who do not report&#xD;
      knowing their HIV status). The CHW will use the electronic data capture devices to collect&#xD;
      all information.&#xD;
&#xD;
      Process Evaluation Measures and Data Collection Process evaluation data will be collected&#xD;
      using standardised data collection forms developed for this trial, including forms to collect&#xD;
      data on how many CHW attended training on the demonstration of HIVST and the number of HIVST&#xD;
      kits procured. Data will also be collected on: 1). the number of households visited and&#xD;
      offered the option of HIVST or door-to-door rapid finger-prick HIV testing, and follow-up&#xD;
      visits to individuals receiving an HIVST kit(s). the number of community engagement&#xD;
      activities performed to inform the community of the availability of HIVST kits. Data on&#xD;
      number of households visited will be collected through the existing EDC devices with data on&#xD;
      community activities collected from routine monitoring data. Expected outputs, namely the&#xD;
      number of HIVST kits distributed for use by individuals present or absent at the time of the&#xD;
      household visit, will also be collected through the existing EDC devices. Data on outcomes of&#xD;
      interest will be collected through the existing EDC devices, with linkage data extracted&#xD;
      using forms developed for HPTN071 and qualitative data collection, including the&#xD;
      acceptability of HIVST and their distribution through CHW.&#xD;
&#xD;
      Measured as part of the Process Evaluation&#xD;
&#xD;
      The following measures will be estimated through qualitative and quantitative data collection&#xD;
      as part of the process evaluation:&#xD;
&#xD;
      Inputs:How many CHW were trained to deliver the intervention? How many HIVST kits were&#xD;
      procured? How many meetings with CABs, community mobilisers and other stakeholds were held?&#xD;
      And how many attendees were at these meetings? Activities: How many door-to-door visits were&#xD;
      conducted? How many communication activities were held in the communities? Outputs: How many&#xD;
      HIVST kits were distributed? Were communities aware of the HIVST intervention and where to&#xD;
      obtain HIVST kits?Was HIVST acceptable? How was it perceived by community members?&#xD;
&#xD;
      Ethical Considerations The trial will be conducted in accordance with Good Clinical Practice&#xD;
      guidelines, and all research staff will receive GCP training. The Ethics Committees to&#xD;
      approve this study will be the Biomedical Ethics Committee of the University of Zambia and&#xD;
      the ethics committee of the London School of Hygiene and Tropical Medicine.&#xD;
&#xD;
      In all communities, HIV testing will follow the Zambian national HIV testing guidelines, with&#xD;
      HIV testing services offered only to individuals aged 16 years or older and informed consent&#xD;
      for HTS obtained as per the Ministry of Health guidelines. Individuals will be informed of&#xD;
      the HTS process and have the right to decline HTS or provide written or verbal consent to HTS&#xD;
      . For individuals absent at the time of the household visit, an index HIV testing client will&#xD;
      be asked whether they agree to accept an HIVST on behalf of the absent household member and&#xD;
      to provide a demonstration on how to perform the test to this same individual. This&#xD;
      individual will be asked to sign an agreement statement, stating that they will only give the&#xD;
      self-test kit to their spouse/partner. The absent individual can decline/opt-out of using the&#xD;
      HIVST and this will be made clear to the individual accepting the HIVST.&#xD;
&#xD;
      Individuals who participate in any in-depth qualitative studies will be asked to provide&#xD;
      written informed research consent.&#xD;
&#xD;
      Potential Harms Despite the increased availability of HIV testing services, including the&#xD;
      door-to-door offer of home-based HIV testing, testing for HIV remains a sensitive issue&#xD;
      subject to stigma and discrimination. HIV self-testing provides individuals more&#xD;
      confidentiality and the opportunity to avoid the stigma of being seen to access HIV testing&#xD;
      services at a clinic. Nonetheless, self-testing may pose harms distinct from facility- or&#xD;
      community-based HIV testing strategies, including concerns of coercion to test.&#xD;
&#xD;
      To date, studies of the distribution of HIV self-tests by volunteer-counsellors in Malawi&#xD;
      have found a low incidence of harms. Some 3% of individuals reported feeling coerced into&#xD;
      self-testing, however, among this group of individuals, 92% were highly satisfied with&#xD;
      self-testing and 94% stated they would recommend self-testing to family/friends.&#xD;
&#xD;
      Despite little evidence for social harms in other settings, offering a female an HIV&#xD;
      self-test for her absent male partner may pose risks, including risk of gender based violence&#xD;
      or coercion to self-test. The CHiPs are trained in providing couples HIV testing and&#xD;
      counselling services and will only leave a self-test kit if it is clear that there is no&#xD;
      history of violence in the relationship. Women will also be informed that the CHiP can return&#xD;
      to counsel the couple on their HIV test result or to support conducting the oral HIV&#xD;
      self-test. The CHiPs will also be trained to ensure that the person they leave the test kit&#xD;
      with has demonstrated that they can read and understand the test instructions and are able to&#xD;
      instruct others to properly conduct an HIV self-test. Further, the CHiPs will also ensure&#xD;
      that the person they leave the test kit with understands the consequences of forced testing&#xD;
      and acknowledges that they will not force anyone to test using the kit. To avoid inadvertent&#xD;
      coercion by leaving an HIV self-test for an individual who refuses the offer of HIV-testing,&#xD;
      a self-test will only be left for individuals who consent to have a self-test left for them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of the total resident adult population who know their HIV status</measure>
    <time_frame>3 Months</time_frame>
    <description>Knowledge of know HIV status includes those individuals who self report to be HIV positive or who test using standard of care HIV tests or oral HIV self test kits with results reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of total resident adult population who consent to participate in the intervention</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of male resident adult population who consent to participate in the intervention</measure>
    <time_frame>3 Months</time_frame>
    <description>Outcome 2 restricted to men</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention</measure>
    <time_frame>3 Months</time_frame>
    <description>Outcome 2 restricted to those community members who have not previously been reached</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of resident adolescent population who consent to participate in the intervention</measure>
    <time_frame>3 Months</time_frame>
    <description>Outcome 2 restricted to adolescents aged 16-18 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of all adults who consent to participate in the intervention who know their HIV status</measure>
    <time_frame>3 Months</time_frame>
    <description>Knowledge of HIV status defined as perproportions of couples who primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of adults who test for HIV amongst those eligible for testing</measure>
    <time_frame>3 Months</time_frame>
    <description>Eligibility for testing includes consent to participate in the intervention and not self-reporting being HIV positive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of couples who test for HIV and receive results as a couple</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors associated with uptake of and experience with HIV self testing</measure>
    <time_frame>3 Months</time_frame>
    <description>Qualitative data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linkage to HIV prevention and care</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost effectiveness of the addition of oral HIV self testing into a package of door-to- door HIV testing provided by CHW</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported social harms associated with HIV testing</measure>
    <time_frame>3 Months</time_frame>
    <description>Social harms will be defined as any adverse event occurring as a direct result of HIV testing including domestic violence, marital break up or suicide. Social harms will be solicited by directly asking participants to report any events and also by passive reporting by community members, advisory boards or other bodies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8080</enrollment>
  <condition>HIV Seropositivity</condition>
  <arm_group>
    <arm_group_label>Oral HIV self test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, community health workers conducting door-to-door HIV testing will offer oral HIV self testing (OraQuick® HIV Self-Test (Orasure Technologies, Thailand)) as an alternative to standard of care finger-prick HIV testing for individuals who are present at the time of the visit. In addition they will provide demonstration to an adult who is present at the time of the visit and leave up to 2 oral HIV self test kits to allow testing with the partner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm community health workers will conduct door-to-door HIV testing using the current Zambian national HIV testing algorithm of finger-prick rapid HIV tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OraQuick® HIV Self-Test (Orasure Technologies, Thailand)</intervention_name>
    <description>All individuals aged 16 and above who are approached by community health workers conducting door-to door HIV testing will be offered the choice to use an oral HIV self test kit or to have standard of care finger-prick rapid HIV testing</description>
    <arm_group_label>Oral HIV self test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident in CHW zone&#xD;
&#xD;
          -  Aged 16 years and above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;16&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alwyn Mwinga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zambart</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zambart</name>
      <address>
        <city>Lusaka</city>
        <zip>10101</zip>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <reference>
    <citation>Hensen B, Lewis JJ, Schaap A, Tembo M, Mutale W, Weiss HA, Hargreaves J, Ayles H. Factors associated with HIV-testing and acceptance of an offer of home-based testing by men in rural Zambia. AIDS Behav. 2015 Mar;19(3):492-504. doi: 10.1007/s10461-014-0866-0.</citation>
    <PMID>25096893</PMID>
  </reference>
  <reference>
    <citation>Musheke M, Bond V, Merten S. Couple experiences of provider-initiated couple HIV testing in an antenatal clinic in Lusaka, Zambia: lessons for policy and practice. BMC Health Serv Res. 2013 Mar 14;13:97. doi: 10.1186/1472-6963-13-97.</citation>
    <PMID>23496926</PMID>
  </reference>
  <reference>
    <citation>Doyle AM, Mavedzenge SN, Plummer ML, Ross DA. The sexual behaviour of adolescents in sub-Saharan Africa: patterns and trends from national surveys. Trop Med Int Health. 2012 Jul;17(7):796-807. doi: 10.1111/j.1365-3156.2012.03005.x. Epub 2012 May 18.</citation>
    <PMID>22594660</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV testing</keyword>
  <keyword>Linkage to care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>the de-identified data will be made available via International Initiative for Evaluation's (3ie) public access data repository.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02994329
org study id: HIV-SELF 3IE
nct id: NCT02994329
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of
      oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of
      home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV
      status among the general adult and adolescent population.

      The primary outcome of the trial is the proportion of individuals who know their HIV status,
      defined as a self-report of being HIV positive or accepting testing (standard or self
      testing) from the CHW.

      Embedded within the impact evaluation is a process evaluation that will explore the fidelity
      of the implementation of the intervention and outputs of the intervention. Qualitative data
      on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any
      impacts on relationships (including between couples and with CHW) associated with use of
      HIVST kits.
Trial Purpose This cluster randomised trial will evaluate the impact of a pilot intervention
      of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of
      home-based rapid HIV testing, by community health workers (CHWs ) on knowledge of HIV status
      among the general adult and adolescent population.

      Aim The overall aim of this trial is to investigate whether the inclusion of HIVST as an
      option for HIV testing, in addition to the offer of HIV testing with a finger-prick blood
      sample, increases the uptake of an offer of home-based HIV-testing overall relative to an
      offer of HIV testing with a finger-prick blood sample alone.

      Secondary Objectives

        1. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to
           the offer of HIV testing with a finger-prick blood sample through CHW increases the
           uptake of an offer of HIV-testing among specific sub-populations including men,
           adolescents and individuals who have not previously tested relative to an offer of HIV
           testing with a finger-prick blood sample alone.

        2. Investigate whether the inclusion of HIVST as an option for HIV testing in addition to
           the offer of HIV testing with a finger-prick blood sample through CHW increases the
           proportion of individuals' diagnosed HIV positive relative to an offer of HIV testing
           with a finger-prick blood sample alone.

        3. Measure linkage to HIV treatment and care, or prevention services when HIVST is included
           as an option for HIV testing in addition to the offer of HIV testing with a finger-prick
           blood sample through CHW and levels of couples-testing.

      Trial Design This cluster randomised trial will randomise community health worker zones (66
      in total) to either distribute oral HIVST kits in addition to the offer of finger-prick rapid
      HIV testing (33 zones) or to offer finger-prick rapid HIV testing alone (33 zones). The trial
      is nested within theHPTN071/PopART trial and the CHWs to be randomised all work in 4 of the
      intervention sites of this study.

      Trial location Four communities in the Copperbelt and Central province of Zambia have been
      chosen to participate in this trial.

      Trial Participants All adults and adolescents aged 16 years or older living in these
      communities are eligible for participation if they consent to participate in the household
      visit and are eligible for HIV testing (individuals aged 16 years or older who do not report
      knowing their HIV status). The CHW will use the electronic data capture devices to collect
      all information.

      Process Evaluation Measures and Data Collection Process evaluation data will be collected
      using standardised data collection forms developed for this trial, including forms to collect
      data on how many CHW attended training on the demonstration of HIVST and the number of HIVST
      kits procured. Data will also be collected on: 1). the number of households visited and
      offered the option of HIVST or door-to-door rapid finger-prick HIV testing, and follow-up
      visits to individuals receiving an HIVST kit(s). the number of community engagement
      activities performed to inform the community of the availability of HIVST kits. Data on
      number of households visited will be collected through the existing EDC devices with data on
      community activities collected from routine monitoring data. Expected outputs, namely the
      number of HIVST kits distributed for use by individuals present or absent at the time of the
      household visit, will also be collected through the existing EDC devices. Data on outcomes of
      interest will be collected through the existing EDC devices, with linkage data extracted
      using forms developed for HPTN071 and qualitative data collection, including the
      acceptability of HIVST and their distribution through CHW.

      Measured as part of the Process Evaluation

      The following measures will be estimated through qualitative and quantitative data collection
      as part of the process evaluation:

      Inputs:How many CHW were trained to deliver the intervention? How many HIVST kits were
      procured? How many meetings with CABs, community mobilisers and other stakeholds were held?
      And how many attendees were at these meetings? Activities: How many door-to-door visits were
      conducted? How many communication activities were held in the communities? Outputs: How many
      HIVST kits were distributed? Were communities aware of the HIVST intervention and where to
      obtain HIVST kits?Was HIVST acceptable? How was it perceived by community members?

      Ethical Considerations The trial will be conducted in accordance with Good Clinical Practice
      guidelines, and all research staff will receive GCP training. The Ethics Committees to
      approve this study will be the Biomedical Ethics Committee of the University of Zambia and
      the ethics committee of the London School of Hygiene and Tropical Medicine.

      In all communities, HIV testing will follow the Zambian national HIV testing guidelines, with
      HIV testing services offered only to individuals aged 16 years or older and informed consent
      for HTS obtained as per the Ministry of Health guidelines. Individuals will be informed of
      the HTS process and have the right to decline HTS or provide written or verbal consent to HTS
      . For individuals absent at the time of the household visit, an index HIV testing client will
      be asked whether they agree to accept an HIVST on behalf of the absent household member and
      to provide a demonstration on how to perform the test to this same individual. This
      individual will be asked to sign an agreement statement, stating that they will only give the
      self-test kit to their spouse/partner. The absent individual can decline/opt-out of using the
      HIVST and this will be made clear to the individual accepting the HIVST.

      Individuals who participate in any in-depth qualitative studies will be asked to provide
      written informed research consent.

      Potential Harms Despite the increased availability of HIV testing services, including the
      door-to-door offer of home-based HIV testing, testing for HIV remains a sensitive issue
      subject to stigma and discrimination. HIV self-testing provides individuals more
      confidentiality and the opportunity to avoid the stigma of being seen to access HIV testing
      services at a clinic. Nonetheless, self-testing may pose harms distinct from facility- or
      community-based HIV testing strategies, including concerns of coercion to test.

      To date, studies of the distribution of HIV self-tests by volunteer-counsellors in Malawi
      have found a low incidence of harms. Some 3% of individuals reported feeling coerced into
      self-testing, however, among this group of individuals, 92% were highly satisfied with
      self-testing and 94% stated they would recommend self-testing to family/friends.

      Despite little evidence for social harms in other settings, offering a female an HIV
      self-test for her absent male partner may pose risks, including risk of gender based violence
      or coercion to self-test. The CHiPs are trained in providing couples HIV testing and
      counselling services and will only leave a self-test kit if it is clear that there is no
      history of violence in the relationship. Women will also be informed that the CHiP can return
      to counsel the couple on their HIV test result or to support conducting the oral HIV
      self-test. The CHiPs will also be trained to ensure that the person they leave the test kit
      with has demonstrated that they can read and understand the test instructions and are able to
      instruct others to properly conduct an HIV self-test. Further, the CHiPs will also ensure
      that the person they leave the test kit with understands the consequences of forced testing
      and acknowledges that they will not force anyone to test using the kit. To avoid inadvertent
      coercion by leaving an HIV self-test for an individual who refuses the offer of HIV-testing,
      a self-test will only be left for individuals who consent to have a self-test left for them.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The proportion of the total resident adult population who know their HIV status
time frame: 3 Months
description: Knowledge of know HIV status includes those individuals who self report to be HIV positive or who test using standard of care HIV tests or oral HIV self test kits with results reported
measure: Proportion of total resident adult population who consent to participate in the intervention
time frame: 3 Months
measure: Proportion of male resident adult population who consent to participate in the intervention
time frame: 3 Months
description: Outcome 2 restricted to men
measure: Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention
time frame: 3 Months
description: Outcome 2 restricted to those community members who have not previously been reached
measure: Proportion of resident adolescent population who consent to participate in the intervention
time frame: 3 Months
description: Outcome 2 restricted to adolescents aged 16-18 years
measure: Proportion of all adults who consent to participate in the intervention who know their HIV status
time frame: 3 Months
description: Knowledge of HIV status defined as perproportions of couples who primary outcome
measure: Proportion of adults who test for HIV amongst those eligible for testing
time frame: 3 Months
description: Eligibility for testing includes consent to participate in the intervention and not self-reporting being HIV positive
measure: Proportion of couples who test for HIV and receive results as a couple
time frame: 3 Months
measure: Factors associated with uptake of and experience with HIV self testing
time frame: 3 Months
description: Qualitative data
measure: Linkage to HIV prevention and care
time frame: 3 Months
measure: Incremental cost effectiveness of the addition of oral HIV self testing into a package of door-to- door HIV testing provided by CHW
time frame: 3 Months
measure: Reported social harms associated with HIV testing
time frame: 3 Months
description: Social harms will be defined as any adverse event occurring as a direct result of HIV testing including domestic violence, marital break up or suicide. Social harms will be solicited by directly asking participants to report any events and also by passive reporting by community members, advisory boards or other bodies
arm group label: Oral HIV self test
arm group type: Active Comparator
description: In this arm, community health workers conducting door-to-door HIV testing will offer oral HIV self testing (OraQuick® HIV Self-Test (Orasure Technologies, Thailand)) as an alternative to standard of care finger-prick HIV testing for individuals who are present at the time of the visit. In addition they will provide demonstration to an adult who is present at the time of the visit and leave up to 2 oral HIV self test kits to allow testing with the partner
arm group label: Standard of Care
arm group type: No Intervention
description: In this arm community health workers will conduct door-to-door HIV testing using the current Zambian national HIV testing algorithm of finger-prick rapid HIV tests
intervention type: Device
intervention name: OraQuick® HIV Self-Test (Orasure Technologies, Thailand)
description: All individuals aged 16 and above who are approached by community health workers conducting door-to door HIV testing will be offered the choice to use an oral HIV self test kit or to have standard of care finger-prick rapid HIV testing
arm group label: Oral HIV self test
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alwyn Mwinga, PhD
role: Principal Investigator
affiliation: Zambart
facility: 
country: Zambia
citation: Hensen B, Lewis JJ, Schaap A, Tembo M, Mutale W, Weiss HA, Hargreaves J, Ayles H. Factors associated with HIV-testing and acceptance of an offer of home-based testing by men in rural Zambia. AIDS Behav. 2015 Mar;19(3):492-504. doi: 10.1007/s10461-014-0866-0.
PMID: 25096893
citation: Musheke M, Bond V, Merten S. Couple experiences of provider-initiated couple HIV testing in an antenatal clinic in Lusaka, Zambia: lessons for policy and practice. BMC Health Serv Res. 2013 Mar 14;13:97. doi: 10.1186/1472-6963-13-97.
PMID: 23496926
citation: Doyle AM, Mavedzenge SN, Plummer ML, Ross DA. The sexual behaviour of adolescents in sub-Saharan Africa: patterns and trends from national surveys. Trop Med Int Health. 2012 Jul;17(7):796-807. doi: 10.1111/j.1365-3156.2012.03005.x. Epub 2012 May 18.
PMID: 22594660
responsible party type: Sponsor
mesh term: HIV Seropositivity
sharing ipd: Yes
ipd description: the de-identified data will be made available via International Initiative for Evaluation's (3ie) public access data repository.