Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0) (NCT07199634) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)
880 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria-
Clinic inclusion criteria:
* Public sector facility
* Primary care, outpatient clinic
* Follows national guidelines for HIV counseling
* Has dedicated HIV counselors
* At least 10 patients receiving HIV counseling per week (based on pre-study data)
* Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)
* Is interested in participating, as indicated by "sign-off" from the head nurse / facility director
Individual participant inclusion criteria:
* Adult (at least 18 years)
* Received HIV post-test counselling or adherence counseling
* Able to consent
* Provides informed consent
* Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga
* Receives care at the facility as evidence by having a clinical record there
Individual participant exclusion Criteria:
* 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.
* Do not speak one of the primary study languages: English, Zulu, Sotho
* Are not able to consent (e.g. intoxicated or of limited mental capacity)
* Do not consent to participate in the study, including linkage to clinical records for follow-up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.