Clinical trial NCT04504357: Integrating U=U Into HIV Counseling in South Africa
Official title: Integrating U=U Into HIV Counseling in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Antiretroviral treatment (ART)
Person living with HIV (PLWH)
Treatment-as-prevention (TasP)
Undetectable=Untransmittable (U=U)
HIV counseling
South Africa
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 Short Message Service (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 PLWH. The intervention will be pre-tested in two focus groups (n=17). (Note: The respondents for phase 1 are not included in clinicaltrial.gov 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.

Eligibility criteria: Inclusion Criteria:

* receiving HIV care at a public sector health facility in South Africa
* Speaks English, Zulu, or Sotho

Exclusion Criteria:

* None

Primary outcomes:
measure: ART uptake and first refill within 60 days (Composite outcome)
timeFrame: 2 months
measure: Documented HIV viral load <50 copies/mL at 6-10 months
timeFrame: 10 months
measure: ART uptake and adherence through 6 months
timeFrame: 6 month
Secondary outcomes:
measure: Started ART within 30 days of baseline
timeFrame: 1 month
measure: Retained in care at 6 months
timeFrame: 6 months
measure: Returned to clinic for couples HIV counseling and testing within 6 months
timeFrame: 6 months
measure: Participated in HIV viral load monitoring at 6 months
timeFrame: 10 months
measure: Change in HIV prevention altruism
timeFrame: baseline, 6 months
measure: Change in internalized HIV stigma, baseline to 6 months
timeFrame: baseline, 6 months
measure: Change in depression score
timeFrame: baseline, 6 months
measure: TasP knowledge at baseline (post-intervention)
timeFrame: baseline (0 months)
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Primary Health Clinic A
state: Gauteng
city: Johannesburg
country: South Africa
facility: Primary Health Clinic B
state: Gauteng
Study officials:
affiliation: BU School of Public Health, Global Health
name: Jacob Bor, ScD SM
role: PRINCIPAL_INVESTIGATOR
References: