Using a point-of-care urine tenofovir test to improve HIV treatment adherence and viral suppression
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (East London) |
| Trial ID | NCT06423612 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
East London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.