NCT04504357Completed
Integrating U=U Into HIV Counseling in South Africa
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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 developed an app-based educational video intervention that provides information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention was 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 hypothesized that disseminating information about U=U and treatment-as-prevention could increase ART adherence, retention, and viral suppression, enabling countries to maximize the impact of test-and-treat.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 135 (actual)
- First submitted
- 4 Aug 2020
- Start date
- Nov 2022
- Primary completion date
- Feb 2024
- Lead sponsor
- Boston University
- Diseases
- HIV
- NCT number
- NCT04504357
What you commit to
- Study type: Interventional
- Participants enrolled: 135
- From Nov 2022 to the primary completion date, Feb 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- receiving HIV care at a public sector health facility in South Africa
- Speaks English, Zulu, or Sotho
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Primary Health Clinic A Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Primary Health Clinic C Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Primary Health Clinic B Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.