Behavioral Intervention for PrEP Adherence in HIV Prevention

(P4W Trial)

Recruiting at 4 trial locations

Overseen By Matthew Mimiaga, ScD MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Severe mental illness, Chronic Hepatitis B, others

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

Compensation: Varies

Number of Visits: 8

500 Participants Needed

Trial Summary

What is the purpose of this trial?

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on participants not currently on PrEP and having no conditions that would prevent starting PrEP.

What data supports the effectiveness of the treatment for PrEP adherence in HIV prevention?

Research shows that strengths-based case management (SBCM) can help people start PrEP by improving their access to healthcare providers. Additionally, daily use of the drug emtricitabine/tenofovir disoproxil fumarate (Truvada) is effective in preventing HIV when taken consistently. ^{1 2 3 4 5}

Is the PrEP treatment safe for humans?

The treatment using emtricitabine/tenofovir disoproxil fumarate (also known as Truvada) is generally considered safe for humans and is approved for preventing HIV in high-risk adults. However, low adherence to the treatment may lead to drug resistance. ^{3 4 5 6 7}

What makes the Behavioral Intervention for PrEP Adherence in HIV Prevention unique?

This treatment is unique because it combines Strengths-Based Case Management (SBCM) with a focus on behavioral and social-cultural factors to improve adherence to PrEP (a medication to prevent HIV). Unlike other treatments, it emphasizes personalized support and navigation to help individuals overcome barriers to accessing and adhering to PrEP. ^{1 8 9 10 11}

Research Team

Katie Biello, PhD

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

This trial is for male sex workers over 18 who have had unprotected anal sex with men in the past 3 months, are HIV negative or unsure, not on PrEP, and can communicate in English or Spanish. They must also have exchanged sex for value within the same timeframe. Those with severe mental/physical conditions, on PrEP from a pilot study, or with health issues like chronic Hepatitis B cannot join.

Inclusion Criteria

I have had unprotected anal sex with a man in the last 3 months.

I identify as male.

I can understand and speak English or Spanish.

Exclusion Criteria

Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)

I am able to understand and consent to participate in the study.

I started PrEP as part of a pilot RCT.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive either standard of care or strength-based case management to facilitate PrEP initiation

2 months

1 visit (in-person) for randomization, ongoing support as needed

Stage 2 Treatment

Participants receive either standard of care or the PrEPare for Work intervention to optimize PrEP adherence

12 months

3 visits (in-person) for adherence sessions, ongoing support via text messaging

Follow-up

Participants are monitored for PrEP adherence and persistence

12 months

Follow-up visits every 4 months

Treatment Details

Interventions

• Stage 1 Strength Based Case Management (SBCM) Condition
• Stage 2 PrEPare for Work Intervention Condition

Trial Overview 'PrEPare for Work' is an RCT aiming to see if a behavioral intervention helps improve uptake, adherence to, and persistence of PrEP among male sex workers. Participants will first receive Strength Based Case Management followed by the 'PrEPare for Work' intervention.

Participant Groups

Group I: Stage 2 PrEPare for Work Intervention Condition Experimental Treatment 1 Intervention

Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Group II: Stage 1 Strength Based Case Management (SBCM) Condition Experimental Treatment 1 Intervention

Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.

Group III: Stage 1 Standard of Care (SOC) Control Condition Active Control 1 Intervention

SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.

Group IV: Stage 2 SOC Control Condition Active Control 1 Intervention

Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Project Weber/RENEW

Collaborator

Trials

1

Recruited

500+

Open Door Health

Collaborator

Trials

1

Recruited

500+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

In a pilot study involving 61 adults interested in PrEP, those receiving strengths-based case management (SBCM) showed a higher rate of completing a provider visit (53.3%) compared to the control group (32.3%), suggesting that SBCM can effectively facilitate access to PrEP care.

Overall, 34% of participants initiated PrEP within 12 weeks, with no significant difference in the time to initiation between the SBCM and control groups, indicating that while SBCM helps with provider visits, it may not speed up the actual start of PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. Doblecki-Lewis, S., Butts, S., Botero, V., et al.[2020]

The iPrEx study showed that daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is effective in reducing HIV acquisition among men who have sex with men, with adherence being crucial for its efficacy.

Qualitative insights from San Francisco participants revealed that strong adherence was supported by established routines, positive relationships with nonjudgmental healthcare staff, and client-centered counseling, while barriers included routine changes and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco. Gilmore, HJ., Liu, A., Koester, KA., et al.[2021]

In the FEM-PrEP trial involving seroconverting women, there was no significant difference in HIV-1 RNA levels or CD4+ T-cell counts between those on PrEP and those on placebo, indicating that PrEP did not lead to better outcomes in these measures.

While no tenofovir resistance was found, FTC resistance was detected in some participants, suggesting that infections may have occurred before starting PrEP, rather than as a result of low adherence to the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. Grant, RM., Liegler, T., Defechereux, P., et al.[2022]

In a study of 350 men who have sex with men, adherence to HIV pre-exposure prophylaxis (PrEP) using emtricitabine/tenofovir was influenced by factors such as location (Harlem vs. Bangkok), education level, and alcohol use, highlighting the importance of understanding social determinants in medication adherence.

The study found that plasma and hair drug concentrations, along with electronic pill bottle data, provided complementary measures of adherence, indicating that multiple methods can be used to assess how well individuals are following their PrEP regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT. Velloza, J., Bacchetti, P., Hendrix, CW., et al.[2023]

A pilot study involving 50 young Black men who have sex with men (BMSM) showed that a culturally-tailored counseling center significantly increased the initiation of PrEP, with 6 participants starting the medication compared to none in the control group after 3 months (p = 0.02).

This suggests that culturally relevant support can effectively improve access to HIV prevention methods like PrEP in populations that are disproportionately affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of a Culturally-Tailored Counseling Intervention to Increase Uptake of HIV Pre-exposure Prophylaxis Among Young Black Men Who Have Sex with Men in Washington, DC. Desrosiers, A., Levy, M., Dright, A., et al.[2022]

In the FEM-PrEP trial, over half of the women were not using effective contraception at enrollment, but 98% adopted either injectable or oral contraceptives, with a pregnancy rate of 9.6 per 100 woman-years overall.

Women using combined oral contraceptives (COCs) had a higher pregnancy rate and lower adherence to the HIV prevention drug TDF-FTC compared to those using injectables, suggesting that long-acting contraceptive methods may be more effective in such trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. Callahan, R., Nanda, K., Kapiga, S., et al.[2022]

Emtricitabine/tenofovir disoproxil fumarate (Truvada) has been approved as an effective preexposure prophylaxis (PrEP) therapy for adults at high risk of acquiring HIV through sexual contact.

The article reviews data that supports the efficacy of PrEP, highlighting its role in preventing HIV infection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. Blackwell, CW.[2015]

Understanding the behavioral and social-cultural factors influencing adherence to pre-exposure prophylaxis (PrEP) is crucial for maximizing its effectiveness in preventing HIV, as current research shows significant variability in product use across different trials.

There is a need for more comprehensive research to identify factors affecting PrEP uptake and adherence, as well as to develop strategies that support consistent use and regular HIV testing, which are essential for optimizing public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Amico, KR.[2022]

Antiretroviral Therapy (ART) and other biomedical interventions like Pre-Exposure Prophylaxis (PrEP) and medical male circumcision have proven effective in preventing HIV transmission, but adherence to these treatments is crucial for their success.

Recent studies highlight that adherence to ART, especially during and after pregnancy, is often below recommended levels, indicating a need for better monitoring and interventions to ensure patients stick to their treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Antiretroviral Therapy for the Success of Emerging Interventions to Prevent HIV Transmission: A Wake up Call. Nachega, JB., Uthman, OA., Mills, EJ., et al.[2021]

In a study involving 23 women who inject drugs, it was found that while PrEP uptake was high, adherence was low due to competing survival needs and structural barriers, such as lack of access in treatment facilities.

Women's perceived need for PrEP varied over time; they were more motivated to adhere during high-risk periods but less committed during low-risk times, indicating that tailored support programs are necessary to improve adherence among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"PrEP just isn't my priority": Adherence challenges among women who inject drugs participating in a pre-exposure prophylaxis (PrEP) demonstration project in Philadelphia, PA USA. Felsher, M., Ziegler, E., Amico, KR., et al.[2022]

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]

References

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

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. [2020]

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

Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco. [2021]

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

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. [2022]

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

Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT. [2023]

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

A Randomized Controlled Pilot Study of a Culturally-Tailored Counseling Intervention to Increase Uptake of HIV Pre-exposure Prophylaxis Among Young Black Men Who Have Sex with Men in Washington, DC. [2022]

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

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. [2022]

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

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]

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

Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. [2022]

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

Adherence to Antiretroviral Therapy for the Success of Emerging Interventions to Prevent HIV Transmission: A Wake up Call. [2021]

10. England pubmed.ncbi.nlm.nih.gov

"PrEP just isn't my priority": Adherence challenges among women who inject drugs participating in a pre-exposure prophylaxis (PrEP) demonstration project in Philadelphia, PA USA. [2022]

11. 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]