Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring.
Xin Niu, Rachel W Kubiak, Oraphan Siriprakaisil...
https://pubmed.ncbi.nlm.nih.gov/36004315Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06423612
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
Led by University of California, San Francisco · Updated on 2025-07-04
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
D
Desmond Tutu HIV Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to improve adherence to antiretroviral therapy (ART) among adults living with HIV who have not achieved viral suppression. The study focuses on using a low-cost, point-of-care urine assay to monitor tenofovir (TFV) levels, aiming to provide real-time feedback to support better ART adherence and increase viral suppression rates. This randomized hybrid type 1 effectiveness study is sponsored by the University of California, San Francisco and targets people receiving primary HIV care in specific clinics in the Eastern Cape region. Participants who have been on ART for at least six months and have not yet achieved viral suppression will be randomly assigned to one of two groups. One group will receive enhanced ART adherence counseling based on results from the point-of-care urine TFV assay, while the other group will follow the standard-of-care enhanced adherence counseling as recommended in South Africa. The total study duration for each participant is 18 months. During the study, participants will be monitored for viral suppression at multiple time points including 6, 9, 12, and 18 months. Additional assessments include resistance testing and genotype analysis at 6 and 18 months. Researchers will also evaluate the feasibility, acceptability, and cost-effectiveness of the urine assay intervention. Participants will receive regular counseling and feedback on their ART adherence, and the study includes both behavioral support and laboratory measures to track outcomes over the 18-month period.
CONDITIONS
Brief Title
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Individuals 18 years of age or older at initial screening living with HIV
- Prescribed antiretroviral therapy (ART) for at least three months
- Not virally suppressed
- HIV care providers in selected clinic sites for feasibility surveys and interviews (for specific study aims)
You will not qualify if you...
- Currently enrolled in another ART adherence intervention
- On ART regimen that does not include Tenofovir
- HIV care providers from non-study sites
- Failure to provide written consent
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 18 months from enrollment
Participants receive either enhanced ART adherence counselling informed by a point-of-care urine assay for TFV or standard-of-care enhanced adherence counselling to improve viral suppression.
1 baseline visit and ongoing visits as part of routine HIV clinical care
Trial Site Locations
Total: 1 location
1
Desmond Tutu HIV Foundation
East London, South Africa
Actively Recruiting
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Research Team
M
Monica Gandhi
P
Purba Chatterjee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.
Matthew A Spinelli, Jessica E Haberer, Peter R Chai...
https://pubmed.ncbi.nlm.nih.gov/32424549Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings.
Monica Gandhi, Guohong Wang, Roger King...
https://pubmed.ncbi.nlm.nih.gov/31634188Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.
Tim R Cressey, Oraphan Siriprakaisil, Rachel W Kubiak...
https://pubmed.ncbi.nlm.nih.gov/32553717Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention.
Paul K Drain, Ashley R Bardon, Jane M Simoni...
https://pubmed.ncbi.nlm.nih.gov/32627120Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial.
Paul Drain, Kenneth Ngure, Nelly Mugo...
https://pubmed.ncbi.nlm.nih.gov/32238341