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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

880 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Boston University

Study start

Oct 5, 2026 Actual

Primary completion

2028-04 Estimated

Study completion

2029-01 Estimated

First posted

Sep 30, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts