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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Motivational Interviewing Counselling, Point-of-care Urine Tenofovir Measurement for HIV prevention?

Research shows that Motivational Interviewing (MI) can improve behaviors related to HIV prevention, such as starting and sticking to PrEP (a medication to prevent HIV). In one study, a brief MI-based intervention helped more people get a PrEP prescription compared to standard counseling, suggesting MI can be effective in promoting PrEP use. ^{1 2 3 4 5}

Is the PrEP Adherence Intervention for HIV Prevention safe for humans?

The research articles reviewed focus on adherence to PrEP for HIV prevention, but they do not provide specific safety data for the interventions like Motivational Interviewing Counselling or Point-of-care Urine Tenofovir Measurement. Generally, PrEP is considered safe for use in humans, but specific safety data for these interventions are not detailed in the provided studies. ^{4 5 6 7 8}

How does Motivational Interviewing Counselling differ from other treatments for PrEP adherence?

Motivational Interviewing Counselling is unique because it focuses on enhancing a person's motivation and commitment to start and stick with PrEP (a medication to prevent HIV) through personalized conversations, rather than just providing information or support. This approach is more interactive and tailored to individual needs, which can help overcome personal barriers to taking PrEP consistently. ^{1 3 4 8 9}

Research Team

Matthew Spinelli, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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 between 18 and 30 years old.

I am a man who has sex with men.

I am currently taking tenofovir-based oral PrEP.

Exclusion Criteria

Participant living with HIV

I am over 30 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using Motivational Interviewing to Increase HIV PrEP Initiation and Adherence: a Scoping Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Open pilot trial of a brief motivational interviewing-based HIV pre-exposure prophylaxis intervention for men who have sex with men: preliminary effects, and evidence of feasibility and acceptability. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence in Men Who Have Sex with Men: Results of a Pilot Randomized Controlled Trial of "Life-Steps for PrEP". [2019]

9. England pubmed.ncbi.nlm.nih.gov

Helping our patients take HIV pre-exposure prophylaxis (PrEP): a systematic review of adherence interventions. [2022]