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

NCT07199634 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2025-09-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

"Undetectable & You" HIV treatment literacy app

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Jacob Bor · BU School of Public Health, Global Health

  • Dorina Onoya, PhD, MBA · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-01
Completion
2029-01-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199634 on ClinicalTrials.gov