PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

NCT05353283 | Completed Results DMC FDA Device

• 1 other identifier: MH122286
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Risk Reduction

Keywords

PrEP; Young MSM; POC monitoring; adherence; motivational interviewing; urine test; tenofovir

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Long-term Adherence Outcomes

  3 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

POC adherence testing by a urine tenofovir assay with motivational interviewing counselling

Behavioral: Motivational Interviewing Counselling; Device: Point-of-care Urine Tenofovir Measurement

Standard of Care

NO INTERVENTION

Adherence counselling provided by the participant's PrEP care provider

Interventions

Motivational Interviewing Counselling BEHAVIORAL

Motivational interviewing-based counseling will be provided to the participant based on the results of the urine test

Intervention Arm

Point-of-care Urine Tenofovir Measurement DEVICE

Urine will be collected and the presence or absence of tenofovir will be measured with the point-of-care urine tenofovir test.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex at birth who has sex with men
• Age 18-30 years-old
• Currently receiving tenofovir-based oral PrEP
• Plans to continue taking daily PrEP over the upcoming 3 months

You may not qualify if:

• Participant living with HIV
• Age \> 30 years

Sponsors & Collaborators

• University of Miami: collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco/San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (4)

• Stalter RM, Baeten JM, Donnell D, Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Mugo N, Mujugira A, Marzinke M, Hendrix C, Gandhi M; Partners PrEP Study Team. Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection. Clin Infect Dis. 2021 Feb 1;72(3):486-489. doi: 10.1093/cid/ciaa785.

  PMID: 33527128 BACKGROUND

• Spinelli MA, Rodrigues WC, Wang G, Vincent M, Glidden DV, Okochi H, Stalter R, Defechereux P, Deutsch M, Grant RM, Ngure K, Mugo NR, Baeten JM, Gandhi M; Partners PrEP Study Team. Brief Report: High Accuracy of a Real-Time Urine Antibody-Based Tenofovir Point-of-Care Test Compared With Laboratory-Based ELISA in Diverse Populations. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):149-152. doi: 10.1097/QAI.0000000000002322.

  PMID: 32167963 BACKGROUND

• Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395.

  PMID: 31634188 BACKGROUND

• Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, Defechereux P, Buchbinder SP, Grant RM, Gandhi M. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867-872. doi: 10.1097/QAD.0000000000002135.

  PMID: 30649051 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Limitations of this study include the small sample size, short follow-up, and inability to assess downstream HIV incidence. Additionally, generalizability may be limited to YMSM engaged via app-based recruitment and willing to self-collect samples. Larger, longer-term RCTs should be completed next to establish efficacy and implementation strategies.

Results Point of Contact

• Title: Matthew Spinelli
• Organization: University of California, San Francisco

matthew.spinelli@ucsf.edu

415-476-4082

Study Officials

• Matthew Spinelli, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 29, 2022
• Study Start: September 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 48 months from start of study
• Access Criteria: Investigators conducting PrEP research who contact the Principal Investigator

Locations

US (1)