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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date pushed from Sep 2026 to Oct 2026
  2. Notable Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Start date: Aug 2026 to Sep 2026
    • Interventions: "Undetectable & You" HIV treatment literacy app (Other) to "Undetectable & You" HIV treatment literacy app (Other)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
  3. Notable Start date: Apr 1, 2026 to Aug 2026
    • Primary completion date: Apr 1, 2028 to Apr 2028
    • Study completion date: Jan 1, 2029 to Jan 2029
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07199634
Lead Sponsor Boston University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
HIV
Enrollment 880 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov