See if the Undetectable & You app helps people with HIV achieve viral suppression in South Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cluster-randomized trial in public sector clinics in South Africa to test the impact of the Undetectable & You HIV treatment literacy app on viral suppression and retention in care. Clinics are paired and randomized to immediate app use or delayed access, with data collected from an active recruitment cohort and a large de-identified national lab dataset. The primary outcome is documented viral load under 200 copies/mL 3–9 months after entry; secondary outcomes include 9–15 month viral suppression, monitoring activity, and retention. The study integrates survey data with routine clinical records to assess effects on ART uptake, adherence, and HIV care engagement. Lead sponsorship is from Boston University with collaboration from NIMH, at sites including the University of Witwatersrand.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Witwatersrand
  Johannesburg, South Africa Recruiting

Study contacts

• Principal investigator: Jacob Bor — BU School of Public Health, Global Health
• Study coordinator: Jacob Bor, ScD, SM
• Email: jbor@bu.edu
• Phone: (617) 414-1446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.