<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/NCT04431154</url>
  </required_header>
  <id_info>
    <org_study_id>HSTAR013</org_study_id>
    <nct_id>NCT04431154</nct_id>
  </id_info>
  <brief_title>Incentives to Promote Sustained Linkage to HIV Care</brief_title>
  <official_title>Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wits Reproductive Health and HIV Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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 study aims to test if small incentives promote linkage to care and 6-month viral&#xD;
      suppression among individuals recently tested for HIV at selected sites within Johannesburg,&#xD;
      South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive&#xD;
      either the standard of care (SOC) for linkage to care or to receive financial incentives for&#xD;
      confirmatory testing, linkage to care and viral suppression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and&#xD;
      HIV Institute (WRHI) in South Africa. This study will leverage on the existing research&#xD;
      infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test&#xD;
      Africa), as well as HIV positive persons identified through other Ezintsha research studies&#xD;
      and at Eztinsha affiliated health clinics.&#xD;
&#xD;
      This study will use a randomized trial design to test the effectiveness of incentives to&#xD;
      increase confirmatory testing, linkage to care and viral suppression. The aim of this study&#xD;
      is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV&#xD;
      virologic suppression if offered financial incentives vs. no incentives (standard of care).&#xD;
&#xD;
      Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV&#xD;
      reactive test in another research study or at a affiliated clinic, will be randomized into&#xD;
      one of two groups: a) a control group that receives the standard of care (SOC) for linkage to&#xD;
      care; and b) an intervention group that receives financial incentives for confirmatory&#xD;
      testing, linkage to care, and viral suppression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 17, 2020</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>Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral suppression at 6 months</measure>
    <time_frame>approximately 6 months</time_frame>
    <description>Viral suppression (plasma HIV RNA &lt;400 copies/mL) at approximately 6 months after a positive HIV result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Confirmatory testing</measure>
    <time_frame>approximately 4 weeks</time_frame>
    <description>Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ART initiation</measure>
    <time_frame>approximately 4 weeks</time_frame>
    <description>ART initiation within approximately 4 weeks after for those newly diagnosed with HIV</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Experimental: Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Incentives and linkage promotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Provision of HIV self-screen kit with incentives and linkage promotion</intervention_name>
    <description>This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care</description>
    <arm_group_label>Experimental: Incentives and linkage promotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reported HIV positive&#xD;
&#xD;
          -  Have a personal and/or valid phone number, that will remain active for 6 months&#xD;
&#xD;
          -  Have a phone with WhatsApp, or text message feature&#xD;
&#xD;
          -  Understand the Informed Consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to provide informed consent&#xD;
&#xD;
          -  Any condition which would make the participant unsuitable or unsafe for enrollment,&#xD;
             i.e. being unable to see or read by forgetting to bring reading glasses, being&#xD;
             intoxicated or acute sickness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harsha Thirumurthy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed Majam, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ezintsha, sub-division of Wits Reproductive Health and HIV Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ezintsha Clinical Research Center</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV self-testing</keyword>
  <keyword>Behavioral sciences</keyword>
  <keyword>Financial incentives</keyword>
  <keyword>Viral suppression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT04431154
org study id: HSTAR013
nct id: NCT04431154
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to test if small incentives promote linkage to care and 6-month viral
      suppression among individuals recently tested for HIV at selected sites within Johannesburg,
      South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive
      either the standard of care (SOC) for linkage to care or to receive financial incentives for
      confirmatory testing, linkage to care and viral suppression.
This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and
      HIV Institute (WRHI) in South Africa. This study will leverage on the existing research
      infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test
      Africa), as well as HIV positive persons identified through other Ezintsha research studies
      and at Eztinsha affiliated health clinics.

      This study will use a randomized trial design to test the effectiveness of incentives to
      increase confirmatory testing, linkage to care and viral suppression. The aim of this study
      is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV
      virologic suppression if offered financial incentives vs. no incentives (standard of care).

      Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV
      reactive test in another research study or at a affiliated clinic, will be randomized into
      one of two groups: a) a control group that receives the standard of care (SOC) for linkage to
      care; and b) an intervention group that receives financial incentives for confirmatory
      testing, linkage to care, and viral suppression.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.
primary purpose: Screening
masking: None (Open Label)
measure: Viral suppression at 6 months
time frame: approximately 6 months
description: Viral suppression (plasma HIV RNA <400 copies/mL) at approximately 6 months after a positive HIV result
measure: Confirmatory testing
time frame: approximately 4 weeks
description: Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.
measure: ART initiation
time frame: approximately 4 weeks
description: ART initiation within approximately 4 weeks after for those newly diagnosed with HIV
arm group label: Experimental: Usual care
arm group type: No Intervention
description: Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.
arm group label: Experimental: Incentives and linkage promotion
arm group type: Experimental
description: Participants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.
intervention type: Behavioral
intervention name: Provision of HIV self-screen kit with incentives and linkage promotion
description: This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care
arm group label: Experimental: Incentives and linkage promotion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Harsha Thirumurthy, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Mohammed Majam, MBA
role: Principal Investigator
affiliation: Ezintsha, sub-division of Wits Reproductive Health and HIV Institute
facility: 
country: South Africa
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections