Integrating U=U Into HIV Counseling in South Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrating U=U Into HIV Counseling in South Africa

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Tablet based U=U app
* Behavioral: U=U videos played in clinic waiting rooms and integrated into HIV counseling session
* Other: Text messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: receiving HIV care at a public sector health facility in South Africa Speaks English, Zulu, or Sotho Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A- No intervention<br>Participants randomized to Arm A will receive no research intervention. | |
| Experimental: Arm B- U=U app<br>Participants randomized to Arm B will receive controlled exposure to the tablet-based U=U app. | Behavioral: Tablet based U=U app<br>* 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.<br>Other: Text messages<br>* Monthly text messages reinforcing intervention content<br>|
| Active Comparator: Arm C- clinical exposure demonstration<br>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 | Behavioral: U=U videos played in clinic waiting rooms and integrated into HIV counseling session<br>* 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.<br>Other: Text messages<br>* Monthly text messages reinforcing intervention content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART uptake and first refill within 60 days (Composite outcome) | 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. | 2 months | 
| TasP knowledge at 6 months | 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. | 6 months | 
| Documented HIV viral load <50 copies/mL at 6-10 months | 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. | 10 months | 
| ART uptake and adherence through 6 months | 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. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Started ART within 30 days of baseline | As documented in linked clinical records | 1 month | 
| Retained in care at 6 months | No more than 30 days late for scheduled clinic visit closest to 6 months post-study enrollment. | 6 months | 
| Returned to clinic for couples HIV counseling and testing within 6 months | Returned to the clinic for couples testing and counseling within six months, based on linked clinical records | 6 months | 
| Participated in HIV viral load monitoring at 6 months | Based on linked clinical records, 6-10 months after baseline | 10 months | 
| Change in HIV prevention altruism | 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. | baseline, 6 months | 
| Change in internalized HIV stigma, baseline to 6 months | 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. | baseline, 6 months | 
| Change in depression score | 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. | baseline, 6 months | 
| TasP knowledge at baseline (post-intervention) | 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. | baseline (0 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral treatment (ART), Person living with HIV (PLWH), Treatment-as-prevention (TasP), Undetectable=Untransmittable (U=U), HIV counseling, South Africa