CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Tablet based U=U app +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04504357
NCT04504357N/ACompleted

Integrating U=U Into HIV Counseling in South Africa

Boston University·interventional·Posted Aug 7, 2020·Updated Aug 19, 2025

In Brief

A clinical study evaluating Tablet based U=U app and Text messages for HIV. Completed, enrolled 135 participants across 3 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesSouth Africa

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 7, 2020
Enrollment StartNov 21, 2022
Primary CompletionFeb 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago

Interventions

Tablet based U=U appbehavioral

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.

Text messagesother

Monthly text messages reinforcing intervention content