An interventional study of Motivational Interviewing Counselling and Point-of-care Urine Tenofovir Measurement in Risk Reduction, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals. Although, pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method, adherence was sufficiently low to comprise efficacy among a high proportion of YMSM in multiple clinical trials and demonstration projects. In this study, the investigators will leverage a novel urine point-of-care drug-level test for PrEP adherence, to both enhance and target motivational-interviewing-based adherence counseling among YMSM, with the goal of preventing HIV infections among this critically at-risk group.
Young men who have sex with men (YMSM; ages 15-29 years) have rising HIV incidence in the United States. Pre-exposure prophylaxis (PrEP) is a highly effective medication prevent HIV infection, both at the individual and population level. However, in several clinical trials and demonstration projects among YMSM, a majority of participants had adherence to PrEP sufficiently low to compromise efficacy throughout the study. Unfortunately, pill-counts and self-reported adherence have limitations in this population, and therapeutic drug monitoring using previously available methods requires expensive equipment and specialized staff, meaning it cannot be implemented at the point-of-care (POC). The investigators have developed a novel POC test to measure urine drug-levels to PrEP for the first time, providing the opportunity to target and enhance adherence counseling during a routine clinical visit. Substantial knowledge gaps on the correct counseling approach and framing of the drug-level feedback message must be addressed to use this strategy to improve adherence among YMSM. This study will use a mixed methods approach to test the central hypothesis that an intervention leveraging a POC urine bioassay to detect PrEP adherence can both target and enhance adherence counseling. Brief interventions are a motivational interviewing (MI) counseling approach with wide uptake by primary care providers for substance use prevention and medical therapy adherence. PrEP2-BAY proposes a brief intervention be used as the framework for POC drug-level feedback among YMSM using PrEP. This study will test the acceptability, feasibility, and preliminary impact on long-term adherence, measured through hair tenofovir levels, of the brief intervention in a pilot randomized controlled trial among YMSM. This proposed research plan has the goal of optimizing PrEP's impact through a novel adherence support intervention. The findings of this proposal will lead to a R01 application to test a POC bioassay-enhanced adherence brief intervention among YMSM in a multi-city trial, with the goal of reducing the burden of HIV among MSM.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 63 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POC adherence testing by a urine tenofovir assay with motivational interviewing counselling
Behavioral: Motivational Interviewing Counselling · Device: Point-of-care Urine Tenofovir Measurement
Adherence counselling provided by the participant's PrEP care provider
Motivational interviewing-based counseling will be provided to the participant based on the results of the urine test
Urine will be collected and the presence or absence of tenofovir will be measured with the point-of-care urine tenofovir test.
Number of Participants Indicating the Intervention Was Acceptable
Number of participants reporting the intervention to be "somewhat" or "very" acceptable on a five-point Likert scale
Time frame: 3 months
Long-term Adherence Outcomes
Measure change in tenofovir levels in hair samples from baseline to 3 months using liquid chromatography-mass spectrometry assays.
Time frame: 3 months
Participants were recruited via targeted advertisements on a geospatial social mobile application.
| Milestone | Intervention Arm | Standard of Care |
|---|---|---|
| Started | 42 | 21 |
| Completed | 41 | 21 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Number of participants reporting the intervention to be "somewhat" or "very" acceptable on a five-point Likert scale
| Participants | Intervention Arm |
|---|---|
| Number of Participants Indicating the Intervention Was Acceptable | 37 |
Measure change in tenofovir levels in hair samples from baseline to 3 months using liquid chromatography-mass spectrometry assays.
| ng/mg | Intervention Arm | Standard of Care |
|---|---|---|
| Baseline tenofovir concentrations in hair | 0.036 ± 0.003 | 0.04 ± 0.006 |
| 3-month follow-up tenofovir concentrations in hair | 0.046 ± 0.0033 | 0.037 ± 0.0056 |
Collected over From enrollment until end of follow-up, up to 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Standard of Care | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
One participant from the intervention arm did not complete the study and was lost to follow-up. One participant from the intervention arm and one participant from the standard of care arm were excluded from analysis due to inadequate hair samples.
| Sex: Female, Male(Participants) | Intervention Arm | Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 40 | 20 | 60 |
| Age, Continuous(Years) | Intervention Arm | Standard of Care | Total |
|---|---|---|---|
| Mean | 26.8 ± 2.6 | 26.1 ± 2.7 | 26.6 ± 2.6 |
| Daily PrEP Regimen(Participants) | Intervention Arm | Standard of Care | Total |
|---|---|---|---|
| Descovy (FTC/TAF) | 20 | 8 | 28 |
| Truvada (FTC/TDF) | 20 | 12 | 32 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 8 | 2 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 23 | 10 | 33 |
| More than one race | 6 | 5 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Arm | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 7 | 21 |
| Not Hispanic or Latino | 26 | 13 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 48 months from start of study
Access criteria: Investigators conducting PrEP research who contact the Principal Investigator
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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