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

ConditionHIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About this trial

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.

Eligibility criteria

Qualifiers

Public sector facility

Primary care, outpatient clinic

Follows national guidelines for HIV counseling

Has dedicated HIV counselors

Disqualifiers

Require acute medical care that would be hindered by participation in the study

Determined by clinical staff not to be physically or emotionally able to initiate ART

Children (under 18 years).

Prisoners or other institutionalized persons.

Trial design

Treatments tested in this trial

  • "Undetectable & You" HIV treatment literacy app

Treatment groups

880 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Boston University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator