PrEP Adherence Intervention for HIV Prevention

(PrEP2-BAY Trial)

Overseen By Matthew A Spinelli, MD, MAS

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: PrEP

Disqualifiers: HIV, Age > 30

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve adherence to HIV prevention medication, known as PrEP, among young men who have sex with men. It tests a new method of monitoring medication adherence through a simple urine test (Point-of-care Urine Tenofovir Measurement), combined with counseling to enhance motivation (Motivational Interviewing Counseling). The goal is to help prevent HIV infections in this at-risk group. Ideal candidates for this trial are men aged 18 to 30 who are currently taking PrEP and plan to continue daily use for the next three months. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in HIV prevention and support.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop other medications, but you must continue taking your current PrEP medication.

What prior data suggests that this intervention is safe for young men who have sex with men?

Research has shown that motivational interviewing is safe and effective. It helps individuals adhere to their health plans, such as taking medication regularly. Studies have found it can increase the use of PrEP (a medicine to prevent HIV) without causing serious side effects.

The urine test used at the point of care to measure tenofovir levels (a drug in PrEP) has also been evaluated for safety. Research indicates it is a practical and safe method to assess adherence to PrEP medication. This test provides quick results and aids in counseling without any known harmful effects.

Both methods aim to safely enhance adherence to PrEP routines, with no significant risks reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to improving adherence to PrEP, a preventive treatment for HIV. Unlike the standard of care, which involves adherence counseling from a participant's PrEP care provider, this trial uses motivational interviewing counseling combined with point-of-care adherence testing via a urine tenofovir assay. This method focuses on personalized motivation and real-time feedback about medication levels, which could enhance adherence and, ultimately, the effectiveness of HIV prevention strategies. By offering a tailored approach that addresses individual barriers to adherence, this trial aims to uncover insights that could lead to more effective HIV prevention methods.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

In this trial, participants in the intervention arm will receive motivational interviewing counseling combined with point-of-care urine tenofovir measurement. Studies have shown that motivational interviewing effectively increases PrEP use (a medication to prevent HIV). This personalized approach helps individuals feel more prepared to follow their treatment plan. Research also shows that quick urine tests at the doctor's office can verify correct PrEP usage. These affordable tests can alert doctors if someone isn't adhering to their prescription. Together, these methods aim to improve adherence to the PrEP routine among young men who have sex with men, helping to prevent HIV infections. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew Spinelli, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man who has sex with men.

I am currently taking tenofovir-based oral PrEP.

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

Exclusion Criteria

Participant living with HIV

I am over 30 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive point-of-care adherence testing and motivational interviewing counseling

3 months

Regular visits for adherence testing and counseling

Follow-up

Participants are monitored for long-term adherence and satisfaction with the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing Counselling
• Point-of-care Urine Tenofovir Measurement

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 2 Interventions

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

Group II: Standard of Care Active Control 1 Intervention

Adherence counselling provided by the participant's PrEP care provider

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Published Research Related to This Trial

An enhanced adherence support program (enPrEP) for oral PrEP did not significantly improve adherence rates among Black MSM and TGW, with only 30% adherence reported at 12 months.

Factors such as lower education levels and depressive symptoms were associated with lower adherence, highlighting the need for innovative strategies to improve PrEP adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. Colson, PW., Franks, J., Wu, Y., et al.[2022]

In a study involving 373 HIV-uninfected partners from serodiscordant couples, SMS surveys revealed that PrEP adherence was high, averaging 92% when participants reported sexual activity, indicating effective monitoring of adherence in real-time.

The findings suggest that while high PrEP adherence is beneficial, it is also associated with increased risk for HIV acquisition during periods of sexual activity, highlighting the importance of ongoing risk assessment in PrEP programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. Haberer, JE., Ngure, K., Muwonge, T., et al.[2022]

In a systematic review of 59 studies involving 43,917 participants, it was found that 41% of individuals discontinued HIV pre-exposure prophylaxis (PrEP) within 6 months, with the highest rates observed in sub-Saharan Africa (47.5%).

Implementing adherence interventions significantly reduced discontinuation rates (24.7% vs 36.7%), and offering flexible dosing options (daily or non-daily) led to lower discontinuation among gay or bisexual men and transgender women (21.6% vs 31.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Zhang, J., Li, C., Xu, J., et al.[2023]

Adherence to antiretroviral-based pre-exposure prophylaxis (PrEP) is crucial for preventing new HIV infections, and understanding how to support sustained adherence is essential for effective PrEP programs.

Key recommendations from four major PrEP trials emphasize the importance of participant-centered approaches, tailored strategies beyond just education, and addressing individual contexts to enhance adherence to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. Amico, KR., Mansoor, LE., Corneli, A., et al.[2023]

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

Citations

1. researchprotocols.org researchprotocols.org/2025/1/e64186/PDF

Developing and Implementing Provider-Training and PrEP training modules, tailored motivational interviewing (TMI) ... published data on awareness, uptake, adherence, and retention in PrEP care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10575988/

Using Motivational Interviewing to Increase HIV PrEP ... This scoping review examines essential components of MI-based interventions that aimed to improve PrEP use, including the number and duration of sessions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3759567/

Motivational interviewing by HIV care providers is ... We analyzed data gathered by the Enhancing Communication and HIV Outcomes (ECHO) study [24–28], a cross-sectional observational study of patient-provider ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824000607

motivational interviewing to support ending the HIV epidemic Motivational interviewing is brief, individualized, and effective in increasing pre-exposure prophylaxis uptake, regardless of patients' readiness to change.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0270302

Provider perspectives on the use of motivational interviewing ... Results. Providers favored the use of a combined adherence counseling technique and POC NAT for their non-adherent patients living with HIV.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5489346/

Does the Quality of SafeTalk Motivational Interviewing ... MI has demonstrated effectiveness in improving health behaviors among people living with HIV, including increasing ARV medication adherence [8–14], reducing ...

7. pure.psu.edu pure.psu.edu/en/publications/using-motivational-interviewing-to-increase-hiv-prep-initiation-a

Using Motivational Interviewing to Increase HIV PrEP ... Motivational interviewing (MI) can improve HIV prevention behaviors. However, limited research identifies how MI impacts PrEP uptake and adherence.

8. ajpmonline.org ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ... This narrative review examines the latest interventions and programs to improve all 3 stages of PrEP adherence and reviews ongoing studies to promote effective ...