N/A
N=100
Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT03935464 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. — 33; 26; 31; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PUMA (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. |
33; 26; 31; 19 | — |
| SECONDARY Feasibility Among Healthcare Providers of Providing Test Feedback to Participants |
6; 8; 3 | — |
Summary
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. We now want to test the acceptability, feasibility and preliminary impact of monitoring adherence in real-time using this novel POC assay with adherence feedback provided to the patient with supportive messaging (versus standard of care adherence counseling).
Eligibility Criteria
Inclusion Criteria
- Female
- Adult, age ≥18 years old
- HIV-1 uninfected based on a negative HIV-1 rapid test
- Not currently enrolled in an HIV-1 prevention clinical trial
- Not currently in a sero-discordant relationship
- Already taking PrEP and will be enrolled at the 3-month follow-up visit following PrEP initiation
- Willing to be randomized to point-of-care tenofovir drug testing
- Willing/able to provide informed consent to participate in the study
- No contraindication to use of TDF or FTC
- Note: Women who are pregnant or breast feeding at screening/enrollment are still eligible
Exclusion Criteria
- HIV positive women
- under 18 years old
Data sourced from ClinicalTrials.gov (NCT03935464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.