Integrating U=U Into HIV Counseling in South Africa

Sponsor
Boston University
Study ID
NCT04504357
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tablet based U=U app — BEHAVIORAL
    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 messages — OTHER
    Monthly text messages reinforcing intervention content

Study Details

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.

Key Dates

Start date
Nov 21, 2022
Status verified
Aug 2025
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Arm A- No intervention
    Participants randomized to Arm A received no research intervention.
  • Experimental: Arm B- "Undetectable & You" App
    Participants randomized to Arm B interacted with "Undetectable \& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.

Primary Outcome Measure

Documented HIV Viral Load <200 Copies/mL at 3-10 Months [ Time Frame: 3-10 months ]

Related Studies