Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)

Sponsor
Boston University
Study ID
NCT07199634
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • "Undetectable & You" HIV treatment literacy app — OTHER
    The app delivers information on the transmission prevention benefits of HIV treatment through the Undetectable Equals Untransmutable (U=U) message, alongside real-life video testimonials of patients living with HIV (PLHIV) and their partners. It underscores the key behavioral skills required for U=U, namely, ART adherence and viral load monitoring.

Study Details

Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called "Undetectable \& You", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the "Undetectable \& You" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa. Aim 1. Refine the "Undetectable \& You" App to help PLHIV navigate U=U within relationships. Aim 2. Establish the real-world impact of "Undetectable \& You" on retention on ART and viral suppression in a cluster-randomized trial.

Key Dates

First listed
Sep 30, 2025
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
880 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Immediate intervention Group A
    Participants whose clinic was randomized into Group A will have immediate access to the "Undetectable \& You" intervention app as part of HIV counseling.
  • Active Comparator: Deferred intervention Group B
    Participants whose clinic was randomized into Group B will get the intervention app at 16 months, after data collection for primary outcomes is complete.

Primary Outcome Measure

HIV viral load <200 copies/mL [ Time Frame: 3-9 months (on average 6 months) ]

Central Contacts

Find similar trials

Nationwide
HIV trialsInfectious disease trials

Related Studies