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Behavioral Intervention

PrEP Adherence Intervention for HIV Prevention (PrEP2-BAY Trial)

N/A

Recruiting

Led By Matthew Spinelli, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-30 years-old

Male sex at birth who has sex with men

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

PrEP2-BAY Trial Summary

This trial is testing a new way to help young men who have sex with men (YMSM) stay on their HIV prevention medication, Pre-Exposure Prophylaxis (PrEP).

Who is the study for?

This trial is for young men aged 18-30 who have sex with men and are currently on tenofovir-based oral PrEP to prevent HIV. They should plan to continue taking PrEP daily for the next three months. Those living with HIV or older than 30 years cannot participate.Check my eligibility

What is being tested?

The study tests a new approach combining urine point-of-care drug-level testing with motivational interviewing counseling, aimed at improving adherence to PrEP medication among young men, in order to reduce their risk of contracting HIV.See study design

What are the potential side effects?

Since this trial focuses on adherence counseling and measurement rather than a new medication, there may not be direct side effects from the interventions themselves. However, participants will continue using their current PrEP regimen which can have side effects like nausea or headaches.

PrEP2-BAY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

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I am a man who has sex with men.

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I am currently taking tenofovir-based oral PrEP.

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I plan to keep taking PrEP daily for the next 3 months.

PrEP2-BAY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interventional procedure

Secondary outcome measures

Long-term adherence outcomes

PrEP2-BAY Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment2 Interventions

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

Group II: Standard of CareActive Control1 Intervention

Adherence counselling provided by the participant's PrEP care provider

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,495 Total Patients Enrolled

5 Trials studying Risk Reduction

881 Patients Enrolled for Risk Reduction

University of MiamiOTHER

902 Previous Clinical Trials

409,956 Total Patients Enrolled

Matthew Spinelli, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Motivational Interviewing Counselling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05353283 — N/A

Risk Reduction Research Study Groups: Intervention Arm, Standard of Care

Risk Reduction Clinical Trial 2023: Motivational Interviewing Counselling Highlights & Side Effects. Trial Name: NCT05353283 — N/A

Motivational Interviewing Counselling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353283 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for this research project?

"Per the details on clinicaltrials.gov, this study is not presently seeking patients; although it was initially posted in January 1st of 2023 and last updated April 25th 2022. Fortunately, there are 28 other trials that currently offer enrollment opportunities for those interested."

Answered by AI

Does this clinical trial include any minors as participants?

"Eligible participants for this clinical trial must be between 18 and 30 years old. For patients under the age of 18, there are 4 other trials available while 23 have been developed specifically with seniors in mind."

Answered by AI

What are the eligibility criteria for enrolling in this clinical trial?

"This research is accruing 60 participants who can benefit from risk reduction, and are aged between 18-30. Prerequisites include: Male sex assigned at birth with history of sexual activity with men, Age bracket of 18-30 years old, Currently taking tenofovir based oral Prep daily for the upcoming 3 months."

Answered by AI

Recent research and studies

JAIDS Journal of Acquired Immune Deficiency SyndromesJournal

Brief Report: High Accuracy of a Real-time Urine Antibody-based Tenofovir Point-of-care Test Compared with Laboratory-based ELISA in Diverse Populations

Spinelli, Matthew A., Warren C. Rodrigues, Guohong Wang, Michael Vincent, David V. Glidden, Hideaki Okochi, Randy Stalter, et al.. 2020. “Brief Report: High Accuracy of a Real-time Urine Antibody-based Tenofovir Point-of-care Test Compared with Laboratory-based ELISA in Diverse Populations”. JAIDS Journal of Acquired Immune Deficiency Syndromes. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qai.0000000000002322.

AidsJournal

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

Gandhi, Monica, Guohong Wang, Roger King, Warren C. Rodrigues, Michael Vincent, David V. Glidden, Tim R. Cressey, et al.. 2020. “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. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qad.0000000000002395.

Clinical Infectious DiseasesJournal

Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection

Stalter, Randy M, Jared M Baeten, Deborah Donnell, Matthew A Spinelli, David V Glidden, Warren C Rodrigues, Guohong Wang, et al.. 2020. “Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciaa785.

AidsJournal