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

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.

NCT Number	NCT07199634
Lead Sponsor	Boston University Collaborators: National Institute of Mental Health (NIMH)
Conditions	HIV
Enrollment	880 participants
Start Date	2026-08
Primary Completion	2028-04 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-25