<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/NCT04504357</url>
  </required_header>
  <id_info>
    <org_study_id>H-40706</org_study_id>
    <secondary_id>R34MH122323</secondary_id>
    <nct_id>NCT04504357</nct_id>
  </id_info>
  <brief_title>Integrating U=U Into HIV Counseling in South Africa</brief_title>
  <acronym>INTUIT-SA</acronym>
  <official_title>Integrating U=U Into HIV Counseling in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</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>
      The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the&#xD;
      world with a clear path to end the HIV epidemic through the mass provision of ART at&#xD;
      diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the&#xD;
      investigators found minimal knowledge of treatment-as-prevention (TasP) in two&#xD;
      population-based surveys recently conducted in South Africa. In addition, current public&#xD;
      health messaging and clinical HIV counselling in South Africa do not emphasize the prevention&#xD;
      benefits of ART.&#xD;
&#xD;
      In this formative research study the investigators will develop an app-based educational&#xD;
      video intervention that will provide information on Undetectable = Untransmittable (U=U) that&#xD;
      is locally-appropriate and can be integrated into routine HIV counselling. The intervention&#xD;
      will be piloted in a clinical trial of patients in South Africa receiving HIV post-test and&#xD;
      adherence counselling services, to determine feasibility and acceptability, impact on U=U&#xD;
      knowledge and attitudes, impact on stigma and psychological well being, and preliminary&#xD;
      evidence for ART uptake and adherence.&#xD;
&#xD;
      The study builds on a longstanding collaboration between Boston University and the Health&#xD;
      Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in&#xD;
      Johannesburg, South Africa. The study is highly innovative because the investigators take a&#xD;
      novel approach - disseminating information on the prevention benefits of ART - to improve the&#xD;
      wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.&#xD;
&#xD;
      The investigators hypothesize that disseminating treatment-as-prevention on its merits could&#xD;
      substantially improve the wellbeing of PLWH and increase demand for ART, enabling countries&#xD;
      to maximize the impact of test-and-treat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1- A video-based &quot;app&quot; will be developed to provide HIV patients with information on&#xD;
      TasP/U=U. The investigators will design a series of short video modules on the prevention&#xD;
      benefits of ART leading to viral suppression and package them as a tablet-based app to&#xD;
      augment existing HIV counseling. In collaboration with the Prevention Access Campaign,&#xD;
      locally-appropriate videos will be developed on (a) the science of TasP/U=U including risks,&#xD;
      (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to&#xD;
      partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation),&#xD;
      and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples&#xD;
      testing. Content will be developed with HIV counselors, PLWH, and other stakeholders in an&#xD;
      Intervention Mapping exercise. After training clinic staff, the videos will be shown in&#xD;
      clinic waiting rooms and the web &quot;app&quot; will be integrated into HIV counseling sessions, to be&#xD;
      shown to patients using tablets. Intervention content will also be pushed to participants via&#xD;
      SMS, and the web &quot;app&quot; will be shared with those with any device with a web browser&#xD;
      application. We will conduct three formative focus groups (n=27) and formative key interviews&#xD;
      (n=27) with PLWHIV. The intervention will be pre-tested in two focus groups (n=17). (NOTE:&#xD;
      THE RESPONDENTS FOR PHASE 1 ARE NOT INCLUDED IN CLINICAL TRIAL REPORTING.)&#xD;
&#xD;
      Phase 2- A clinical trial will be conducted using two recruitment periods at three public&#xD;
      sector clinics to establish intervention acceptability, effects on knowledge and attitudes,&#xD;
      and preliminary impact on ART uptake, adherence, and viral suppression in a pilot trial and&#xD;
      demonstration project (n=135).&#xD;
&#xD;
      During recruitment period 1 (n=90), patients completing HIV post-test or adherence counseling&#xD;
      will be referred to study staff and randomized 1:1 to no intervention (Arm A) vs. &quot;controlled&#xD;
      exposure&quot; to the tablet-based U=U app (Arm B). In recruitment period 2 (n=45), U=U videos&#xD;
      will be shown in clinic waiting rooms and the tablet-based app will be integrated into&#xD;
      routine counseling (Arm C) in a &quot;clinical exposure&quot; demonstration project.&#xD;
&#xD;
      Participants in Arms B and C will also receive monthly text messages reinforcing intervention&#xD;
      content. The order of the messages will be randomized to ascertain whether different messages&#xD;
      were better at driving engagement with the App. Respondents will be free to opt out of these&#xD;
      text messages. For all study arms, investigators will assess feasibility and acceptability,&#xD;
      resonance of different key messages and videos, knowledge and attitudes related to TasP,&#xD;
      internalized stigma and mental health, HIV prevention altruism, and behaviours related to&#xD;
      disclosure, risk-taking, and care-seeking in surveys at enrolment, post-test, and 6 months.&#xD;
      ART uptake, appointment adherence, and 6-month VL will be assessed in clinical records.&#xD;
      Qualitative exit interviews will be conducted with participants and clinic staff (n=30).&#xD;
&#xD;
      In addition to the primary and secondary outcomes specified below, we will assess for effect&#xD;
      modification in primary outcomes by key constructs of our theoretical model including&#xD;
      baseline awareness of TasP; baseline altruistic motivations; and baseline behavioral skills&#xD;
      associated with TasP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2022</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>ART uptake and first refill within 60 days (Composite outcome)</measure>
    <time_frame>2 months</time_frame>
    <description>Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TasP knowledge at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>TasP knowledge will be defined as the &quot;perceived reduction in transmission risk due to HIV treatment&quot;. Participants will be asked about the likelihood of HIV transmission (on a 0 to 10 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is NOT on ART; we will then ask about a a similar scenario in which the HIV+ partner is on virally-suppressive ART. Perceived reduction in transmission risk due to HIV treatment will be defined as &quot;100% minus 100%* the ratio of perceived risk of transmission with virally-suppressive ART vs. perceived risk of transmission without ART.&quot; (For details on the measure, see Bor et al. 2021 STI: http://dx.doi.org/10.1136/sextrans-2021-055031.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Documented HIV viral load &lt;50 copies/mL at 6-10 months</measure>
    <time_frame>10 months</time_frame>
    <description>As documented in linked clinical records. The first viral load (VL) value taken during the period 6-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL&lt;50; 0 = VL&gt;=50 OR no VL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ART uptake and adherence through 6 months</measure>
    <time_frame>6 month</time_frame>
    <description>Number of days during the six months following study enrollment for which ART medication was disbursed; obtained from linked clinical records (range: 0 to 182). Outcome defined such that the length of the last disbursement is censored at 182 days after study enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Started ART within 30 days of baseline</measure>
    <time_frame>1 month</time_frame>
    <description>As documented in linked clinical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retained in care at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>No more than 30 days late for scheduled clinic visit closest to 6 months post-study enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Returned to clinic for couples HIV counseling and testing within 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Returned to the clinic for couples testing and counseling within six months, based on linked clinical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participated in HIV viral load monitoring at 6 months</measure>
    <time_frame>10 months</time_frame>
    <description>Based on linked clinical records, 6-10 months after baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HIV prevention altruism</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>An adapted version of an HIV prevention altruism scale developed by King et al. 2009 (https://pubmed.ncbi.nlm.nih.gov/19101063/) will be used to assess this outcome. The scale measures level of altruistic motivations toward prevention of HIV transmission. The scale has nine 4-category Likert items (three are reverse-coded). The total has a range of 9 to 36, with higher scores indicating a higher level of HIV prevention altruism. This outcome will be assessed at baseline (pre-intervention) and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in internalized HIV stigma, baseline to 6 months</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Internalized HIV stigma will be measured with the Internalized AIDS-Related Stigma Scale (Kalichman et al. 2009). The scale includes six dichotomous items, which are summed so that the total score has a range of 0 to 6, with higher numbers reflecting greater internalized stigma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression score</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>The Kessler Psychological Distress Scale (K6+) is a 6-item self-report measure of psychological distress is a quick tool to assess risk for serious mental illness in the general population during the past 30 days using a 5-point Likert scale: 4 (All of the time), 3 (Most of the time), 2 (Some of the time), 1 (A little of the time), and 0 (None of the time). This generates a scoring scale with a range of 0 to 24. Higher scores are associated with more distress and depression. This outcome will be assessed at baseline (pre-intervention) and 6 months. We will assess differences in changes between treated and controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TasP knowledge at baseline (post-intervention)</measure>
    <time_frame>baseline (0 months)</time_frame>
    <description>TasP knowledge will be defined as the &quot;perceived reduction in transmission risk due to HIV treatment&quot;. Participants will be asked about the likelihood of HIV transmission (on a 0 to 10 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is NOT on ART. Participants will then be asked about a a similar scenario in which the HIV+ partner is on virally-suppressive ART. Perceived reduction in transmission risk due to HIV treatment will be defined as &quot;100% minus 100%* the ratio of perceived risk of transmission with virally-suppressive ART vs. perceived risk of transmission without ART.&quot; (For details on the measure, see Bor et al. 2021 STI: http://dx.doi.org/10.1136/sextrans-2021-055031.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Arm A- No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to Arm A will receive no research intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B- U=U app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Arm B will receive &quot;controlled exposure&quot; to the tablet-based U=U app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C- clinical exposure demonstration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to Arm C will be shown U=U videos in clinic waiting rooms and the tablet-based app will be integrated into routine counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tablet based U=U app</intervention_name>
    <description>Tablet based &quot;app&quot; focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.</description>
    <arm_group_label>Arm B- U=U app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>U=U videos played in clinic waiting rooms and integrated into HIV counseling session</intervention_name>
    <description>TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.</description>
    <arm_group_label>Arm C- clinical exposure demonstration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text messages</intervention_name>
    <description>Monthly text messages reinforcing intervention content</description>
    <arm_group_label>Arm B- U=U app</arm_group_label>
    <arm_group_label>Arm C- clinical exposure demonstration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  receiving HIV care at a public sector health facility in South Africa&#xD;
&#xD;
          -  Speaks English, Zulu, or Sotho&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob Bor, ScD SM</last_name>
    <role>Principal Investigator</role>
    <affiliation>BU School of Public Health, Global Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jacob Bor, ScD SM</last_name>
    <phone>(617) 358-2176</phone>
    <email>jbor@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dorina Onoya, PhD</last_name>
    <email>donoya@heroza.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Primary Health Clinic A</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorina Onoya</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Primary Health Clinic B</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorina Onoya</last_name>
    </contact>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antiretroviral treatment (ART)</keyword>
  <keyword>Person living with HIV (PLWH)</keyword>
  <keyword>Treatment-as-prevention (TasP)</keyword>
  <keyword>Undetectable=Untransmittable (U=U)</keyword>
  <keyword>HIV counseling</keyword>
  <keyword>South Africa</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04504357
org study id: H-40706
secondary id: R34MH122323
nct id: NCT04504357
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the
      world with a clear path to end the HIV epidemic through the mass provision of ART at
      diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the
      investigators found minimal knowledge of treatment-as-prevention (TasP) in two
      population-based surveys recently conducted in South Africa. In addition, current public
      health messaging and clinical HIV counselling in South Africa do not emphasize the prevention
      benefits of ART.

      In this formative research study the investigators will develop an app-based educational
      video intervention that will provide information on Undetectable = Untransmittable (U=U) that
      is locally-appropriate and can be integrated into routine HIV counselling. The intervention
      will be piloted in a clinical trial of patients in South Africa receiving HIV post-test and
      adherence counselling services, to determine feasibility and acceptability, impact on U=U
      knowledge and attitudes, impact on stigma and psychological well being, and preliminary
      evidence for ART uptake and adherence.

      The study builds on a longstanding collaboration between Boston University and the Health
      Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in
      Johannesburg, South Africa. The study is highly innovative because the investigators take a
      novel approach - disseminating information on the prevention benefits of ART - to improve the
      wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.

      The investigators hypothesize that disseminating treatment-as-prevention on its merits could
      substantially improve the wellbeing of PLWH and increase demand for ART, enabling countries
      to maximize the impact of test-and-treat.
Phase 1- A video-based "app" will be developed to provide HIV patients with information on
      TasP/U=U. The investigators will design a series of short video modules on the prevention
      benefits of ART leading to viral suppression and package them as a tablet-based app to
      augment existing HIV counseling. In collaboration with the Prevention Access Campaign,
      locally-appropriate videos will be developed on (a) the science of TasP/U=U including risks,
      (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to
      partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation),
      and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples
      testing. Content will be developed with HIV counselors, PLWH, and other stakeholders in an
      Intervention Mapping exercise. After training clinic staff, the videos will be shown in
      clinic waiting rooms and the web "app" will be integrated into HIV counseling sessions, to be
      shown to patients using tablets. Intervention content will also be pushed to participants via
      SMS, and the web "app" will be shared with those with any device with a web browser
      application. We will conduct three formative focus groups (n=27) and formative key interviews
      (n=27) with PLWHIV. The intervention will be pre-tested in two focus groups (n=17). (NOTE:
      THE RESPONDENTS FOR PHASE 1 ARE NOT INCLUDED IN CLINICAL TRIAL REPORTING.)

      Phase 2- A clinical trial will be conducted using two recruitment periods at three public
      sector clinics to establish intervention acceptability, effects on knowledge and attitudes,
      and preliminary impact on ART uptake, adherence, and viral suppression in a pilot trial and
      demonstration project (n=135).

      During recruitment period 1 (n=90), patients completing HIV post-test or adherence counseling
      will be referred to study staff and randomized 1:1 to no intervention (Arm A) vs. "controlled
      exposure" to the tablet-based U=U app (Arm B). In recruitment period 2 (n=45), U=U videos
      will be shown in clinic waiting rooms and the tablet-based app will be integrated into
      routine counseling (Arm C) in a "clinical exposure" demonstration project.

      Participants in Arms B and C will also receive monthly text messages reinforcing intervention
      content. The order of the messages will be randomized to ascertain whether different messages
      were better at driving engagement with the App. Respondents will be free to opt out of these
      text messages. For all study arms, investigators will assess feasibility and acceptability,
      resonance of different key messages and videos, knowledge and attitudes related to TasP,
      internalized stigma and mental health, HIV prevention altruism, and behaviours related to
      disclosure, risk-taking, and care-seeking in surveys at enrolment, post-test, and 6 months.
      ART uptake, appointment adherence, and 6-month VL will be assessed in clinical records.
      Qualitative exit interviews will be conducted with participants and clinic staff (n=30).

      In addition to the primary and secondary outcomes specified below, we will assess for effect
      modification in primary outcomes by key constructs of our theoretical model including
      baseline awareness of TasP; baseline altruistic motivations; and baseline behavioral skills
      associated with TasP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: ART uptake and first refill within 60 days (Composite outcome)
time frame: 2 months
description: Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.
measure: TasP knowledge at 6 months
time frame: 6 months
description: TasP knowledge will be defined as the "perceived reduction in transmission risk due to HIV treatment". Participants will be asked about the likelihood of HIV transmission (on a 0 to 10 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is NOT on ART; we will then ask about a a similar scenario in which the HIV+ partner is on virally-suppressive ART. Perceived reduction in transmission risk due to HIV treatment will be defined as "100% minus 100%* the ratio of perceived risk of transmission with virally-suppressive ART vs. perceived risk of transmission without ART." (For details on the measure, see Bor et al. 2021 STI: http://dx.doi.org/10.1136/sextrans-2021-055031.
measure: Documented HIV viral load <50 copies/mL at 6-10 months
time frame: 10 months
description: As documented in linked clinical records. The first viral load (VL) value taken during the period 6-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL<50; 0 = VL>=50 OR no VL.
measure: ART uptake and adherence through 6 months
time frame: 6 month
description: Number of days during the six months following study enrollment for which ART medication was disbursed; obtained from linked clinical records (range: 0 to 182). Outcome defined such that the length of the last disbursement is censored at 182 days after study enrollment.
measure: Started ART within 30 days of baseline
time frame: 1 month
description: As documented in linked clinical records
measure: Retained in care at 6 months
time frame: 6 months
description: No more than 30 days late for scheduled clinic visit closest to 6 months post-study enrollment.
measure: Returned to clinic for couples HIV counseling and testing within 6 months
time frame: 6 months
description: Returned to the clinic for couples testing and counseling within six months, based on linked clinical records
measure: Participated in HIV viral load monitoring at 6 months
time frame: 10 months
description: Based on linked clinical records, 6-10 months after baseline
measure: Change in HIV prevention altruism
time frame: baseline, 6 months
description: An adapted version of an HIV prevention altruism scale developed by King et al. 2009 (https://pubmed.ncbi.nlm.nih.gov/19101063/) will be used to assess this outcome. The scale measures level of altruistic motivations toward prevention of HIV transmission. The scale has nine 4-category Likert items (three are reverse-coded). The total has a range of 9 to 36, with higher scores indicating a higher level of HIV prevention altruism. This outcome will be assessed at baseline (pre-intervention) and 6 months.
measure: Change in internalized HIV stigma, baseline to 6 months
time frame: baseline, 6 months
description: Internalized HIV stigma will be measured with the Internalized AIDS-Related Stigma Scale (Kalichman et al. 2009). The scale includes six dichotomous items, which are summed so that the total score has a range of 0 to 6, with higher numbers reflecting greater internalized stigma.
measure: Change in depression score
time frame: baseline, 6 months
description: The Kessler Psychological Distress Scale (K6+) is a 6-item self-report measure of psychological distress is a quick tool to assess risk for serious mental illness in the general population during the past 30 days using a 5-point Likert scale: 4 (All of the time), 3 (Most of the time), 2 (Some of the time), 1 (A little of the time), and 0 (None of the time). This generates a scoring scale with a range of 0 to 24. Higher scores are associated with more distress and depression. This outcome will be assessed at baseline (pre-intervention) and 6 months. We will assess differences in changes between treated and controls.
measure: TasP knowledge at baseline (post-intervention)
time frame: baseline (0 months)
description: TasP knowledge will be defined as the "perceived reduction in transmission risk due to HIV treatment". Participants will be asked about the likelihood of HIV transmission (on a 0 to 10 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is NOT on ART. Participants will then be asked about a a similar scenario in which the HIV+ partner is on virally-suppressive ART. Perceived reduction in transmission risk due to HIV treatment will be defined as "100% minus 100%* the ratio of perceived risk of transmission with virally-suppressive ART vs. perceived risk of transmission without ART." (For details on the measure, see Bor et al. 2021 STI: http://dx.doi.org/10.1136/sextrans-2021-055031.
arm group label: Arm A- No intervention
arm group type: No Intervention
description: Participants randomized to Arm A will receive no research intervention.
arm group label: Arm B- U=U app
arm group type: Experimental
description: Participants randomized to Arm B will receive "controlled exposure" to the tablet-based U=U app.
arm group label: Arm C- clinical exposure demonstration
arm group type: Active Comparator
description: Participants randomized to Arm C will be shown U=U videos in clinic waiting rooms and the tablet-based app will be integrated into routine counseling
intervention type: Behavioral
intervention name: Tablet based U=U app
description: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.
arm group label: Arm B- U=U app
intervention type: Behavioral
intervention name: U=U videos played in clinic waiting rooms and integrated into HIV counseling session
description: TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.
arm group label: Arm C- clinical exposure demonstration
intervention type: Other
intervention name: Text messages
description: Monthly text messages reinforcing intervention content
arm group label: Arm B- U=U app
arm group label: Arm C- clinical exposure demonstration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacob Bor, ScD SM
role: Principal Investigator
affiliation: BU School of Public Health, Global Health
last name: Jacob Bor, ScD SM
phone: (617) 358-2176
email: jbor@bu.edu
last name: Dorina Onoya, PhD
email: donoya@heroza.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: South Africa
responsible party type: Sponsor
sharing ipd: No