Using a point-of-care urine tenofovir test to improve HIV treatment adherence and viral suppression
Official title: Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
Run by University of California, San Francisco · NCT06423612 · Data updated 2026-11-12
This will test whether giving adults with HIV who are not yet virally suppressed a quick urine test showing recent tenofovir use, plus targeted counseling, helps them reach viral suppression in clinics in the Eastern Cape, South Africa.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (East London) |
| Status | Recruiting |
| Started | May 8, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT06423612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) living with HIV at participating Eastern Cape clinics who have been on a tenofovir-containing ART regimen for at least six months and are not virally suppressed, and who can provide consent, are ideal candidates.
✕Probably not a fit
People already virally suppressed, those on ART regimens without tenofovir, patients enrolled in other adherence interventions, or individuals who cannot attend the participating clinics are unlikely to benefit from this intervention.
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 randomized, hybrid type 1 effectiveness trial enrolling about 500 adults living with HIV who receive primary care at selected clinics in Buffalo City Municipality, Eastern Cape. Participants on tenofovir-containing ART who have not achieved viral suppression after at least six months on treatment will be randomized 1:1 to receive point-of-care urine tenofovir testing with enhanced adherence counseling versus standard of care. The trial combines measurement of clinical effectiveness (viral suppression) with implementation outcomes including acceptability, feasibility, and cost-effectiveness among patients and providers. Total planned follow-up from enrollment is 18 months, with mixed-methods surveys and in-depth interviews informing implementation factors.
Why it matters
Potential benefit: If successful, the approach could increase rates of viral suppression by providing real-time, objective adherence feedback that enables targeted counseling and support.
How similar studies have gone: Observational and pilot studies have shown that urine tenofovir testing reliably reflects recent adherence and can guide counseling, but randomized data on improving viral suppression in routine care are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Aim 1: Individuals ≥18 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed. Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews. Aim 3: Same as Aim 1 for the cost-effectiveness study. Exclusion Criteria: * Currently enrolled in another ART adherence intervention * Patients on ART regimen that does not include Tenofovir * HIV care providers from non-study sites Failure to provide written consent
Where it's running
-
Desmond Tutu HIV Foundation
East London, South Africa Recruiting
Study contacts
- Principal investigator: Monica Gandhi — University of California, San Francisco
- Study coordinator: Monica Gandhi
- Email: monica.gandhi@ucsf.edu
- Phone: 415 476 4082
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.