Bringing 'Undetectable = Untransmittable' messages into HIV counseling

Integrating U=U into HIV counseling: a cluster-randomized efficacy trial (INTUIT 2.0)

['FUNDING_R01'] · BOSTON UNIVERSITY MEDICAL CAMPUS · NIH-11192821

This project will see if a counseling app that explains 'Undetectable = Untransmittable (U=U)' helps people with HIV start and stay on treatment and reach undetectable viral loads.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorBOSTON UNIVERSITY MEDICAL CAMPUS (nih funded)
Locations1 site (BOSTON, UNITED STATES)
Trial IDNIH-11192821 on ClinicalTrials.gov

What this research studies

You would receive counseling at clinics in South Africa where some counselors use the 'Undetectable & You' app and others provide standard counseling. The app was co-created with people living with HIV and health providers and combines personal stories with clear science about U=U. About 880 people will be followed in a cluster-randomized trial, with surveys and viral load results collected through the National Health Laboratory Service to measure treatment adherence and viral suppression. The research team refined the app in a prior pilot before launching this larger effectiveness trial.

Who could benefit from this research

Good fit: Adults living with HIV who attend participating clinics in South Africa and are willing to receive counseling and share survey and lab data are ideal candidates.

Not a fit: People who do not attend the participating clinics or who are not interested in counseling or data-sharing would not directly benefit from joining this trial.

Why it matters

Potential benefit: If successful, this could reduce HIV stigma and help more people reach and maintain undetectable viral loads, lowering the risk of onward transmission.

How similar studies have performed: Prior evidence shows U=U messaging can reduce stigma and increase testing, and a prior pilot of the 'Undetectable & You' app supported moving to this larger randomized trial.

Where this research is happening

BOSTON, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.