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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach can help male sex workers consistently take PrEP, a medication that prevents HIV. It tests two methods: Stage 1 Strength Based Case Management (SBCM) offers guidance and motivation to start PrEP, while Stage 2 PrEPare for Work Intervention provides personal counseling and daily text reminders to maintain adherence. Men who have had condomless sex and exchanged sex for money or other items in the past three months may qualify if they are HIV-negative or unsure of their status. As an unphased trial, this study allows participants to contribute to innovative strategies that could improve PrEP adherence and HIV prevention.

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 prior data suggests that this behavioral intervention is safe for improving PrEP adherence?

Research has shown that strength-based case management (SBCM) is both effective and safe. One study found that this method successfully connected people to HIV care without causing significant side effects. Other studies indicate that SBCM helps people begin and continue using HIV prevention treatments, such as PrEP.

Regarding the PrEPare for Work program, PrEP itself has undergone extensive research and is considered safe. Many studies have demonstrated that PrEP significantly lowers the risk of HIV infection and is generally well-tolerated by most people. Reports of serious side effects are rare, making it a dependable preventive option.

Both approaches aim to help individuals manage their health more effectively, and existing research supports their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for improving PrEP adherence because they focus on personalized support and practical engagement strategies that go beyond standard informational approaches. The Strength Based Case Management (SBCM) approach offers tailored support by connecting individuals with trained case managers who motivate and guide them to access PrEP, making the process more accessible and supportive. Meanwhile, the PrEPare for Work intervention provides personalized counseling and daily text reminders to boost adherence, using technology to keep participants engaged and accountable. These methods aim to address the real-world challenges of sticking to a PrEP regimen, potentially leading to better adherence rates compared to traditional methods that primarily rely on informational pamphlets or standard care.

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

Research has shown that Strength Based Case Management (SBCM), which participants in this trial may receive, effectively connects people to medical care, including HIV prevention services like PrEP. Studies have demonstrated that this approach increases HIV testing and links people to the healthcare resources they need.

In this trial, the PrEPare for Work program is another intervention being tested. Research on PrEP (Pre-Exposure Prophylaxis) is strong, with its main ingredients, emtricitabine and tenofovir disoproxil fumarate, proving very effective in preventing HIV among men who have sex with men. Real-world evidence supports that using PrEP can greatly reduce new HIV cases. The PrEPare for Work program combines counseling and reminders to help people take PrEP regularly, maintaining its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Katie Biello, PhD

Principal Investigator

Brown University School of Public Health

Are You a Good Fit for This Trial?

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.

Report HIV status as negative or unsure

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918697/

Contingency Management and Pre-Exposure Prophylaxis ... Among PWID, CM improves substance use outcomes, prevention and treatment of infectious diseases, and medication adherence. For some, CM alone may be an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780651/

Outcomes of a pilot randomized clinical trial testing brief ... Adapted SBCM approaches have shown efficacy in increasing HIV testing and linkage to medical care among people who use drugs in urban areas as ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003639

Contingency Management and Pre-Exposure Prophylaxis ... We are conducting a randomized controlled trial to evaluate the impact of CM with, as indicated, PrEP Adherence Support Services (PASS) (CoMPASS) compared to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06666309

Adaptive Intervention Strategies for HIV PrEP Care in Rural ... During this 5-year study, stepped-care adaptive interventions will be deployed in three rural syringe service programs in a Sequential Multiple Assignment ...

5. 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 ...

6. journals.lww.com journals.lww.com/aidsonline/fulltext/2019/07150/a_strengths_based_case_management_intervention_to.7.aspx

A strengths-based case management intervention to link... The Linking Infectious and Narcology Care strengths-based case management intervention was more effective than usual care in linking Russian PWID to HIV care.

7. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00252-2/fulltext

Optimal strategies to improve uptake of and adherence ... The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use ...