Contingency Management for HIV Prevention

(CoMPASS Trial)

Recruiting at 3 trial locations

Overseen By June-Marie C Weiss, MA, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: PrEP

Disqualifiers: Pregnancy, Kidney disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 24 weeks

526 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) for HIV prevention?

The research indicates that PrEP (Pre-Exposure Prophylaxis) is an effective HIV prevention method, with strong adherence noted among patients who actively seek it. Additionally, client-centered counseling and support from healthcare providers are important for maintaining adherence to PrEP, which is a key component of the CoMPASS treatment. ^{1 2 3 4 5}

How is the CoMPASS treatment for HIV prevention different from other treatments?

The CoMPASS treatment is unique because it combines contingency management (a behavioral strategy that uses rewards to encourage positive behavior) with stepped care to improve adherence to PrEP (pre-exposure prophylaxis) and support services. This approach focuses on enhancing adherence to PrEP, which is crucial for its effectiveness in preventing HIV, by providing tailored support and incentives. ^{1 3 6 7 8}

Research Team

E. Jennifer Edelman, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with opioid use disorder who inject drugs and are at risk for HIV. They must meet PrEP eligibility, have a recent negative HIV test, own or share a cell phone, and be willing to complete surveys. Exclusions include non-English speakers without translation support, kidney disease, current PrEP users, pregnant or breastfeeding women, and those unable to finish the study.

Inclusion Criteria

Currently employed at one of the participating study sites

Provide written informed consent

Have a cell phone or use of a household member's cell phone

Exclusion Criteria

I do not speak English.

Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive

Inability to provide at least one collateral contact for a friend or family member.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive contingency management with stepped care to PrEP adherence and support services (CoMPASS) or treatment as usual (TAU) for 24 weeks

24 weeks

9 visits (in-person) for CoMPASS group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of sexually transmitted infections and HIV acquisition

12 months

Treatment Details

Interventions

• Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)

Trial Overview The study tests CoMPASS—a program combining contingency management with support services—to improve adherence to PrEP among people who inject drugs. It's a 24-week intervention followed by a year of monitoring their health outcomes and evaluating how well the program works in real-world settings.

Participant Groups

Group I: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) Experimental Treatment 1 Intervention

Participants randomized to Compass will also receive a health handout on HIV risk reduction approaches. They will also receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12, will be "stepped up" to receive PrEP adherence and support services (n=5).

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Participants randomized to TAU will receive a health handout on HIV risk reduction approaches, including PrEP and OUD-related care, and where to access such services. They will receive standard care as provided by the community-based organization and by their medical provider.

Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) is already approved in United States, European Union for the following indications:

Approved in United States as Truvada for:

• Prevention of HIV-1 infection in adults and adolescents weighing at least 35 kg (77 lb) at increased risk of HIV acquisition

Approved in European Union as Truvada for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Approved in United States as Descovy for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex

Approved in European Union as Descovy for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A qualitative study involving 18 U.S.-based PrEP providers revealed that most had positive experiences with prescribing PrEP, indicating that common barriers like financial coverage and side effects were generally manageable.

Providers noted that patient adherence to PrEP was better among those who actively sought it out, and they emphasized the need for improved training for inexperienced providers, particularly in areas like sexual history-taking and understanding sexual minority issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting PrEP into Practice: Lessons Learned from Early-Adopting U.S. Providers' Firsthand Experiences Providing HIV Pre-Exposure Prophylaxis and Associated Care. Calabrese, SK., Magnus, M., Mayer, KH., 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]

A systematic review identified 16 studies on alternative HIV preexposure prophylaxis (PrEP) care delivery models, highlighting promising approaches like pharmacist prescribers, telePrEP, and mail-in testing to enhance access to PrEP services.

Despite the low risk of bias in most studies, none met the established criteria for evidence-based interventions, indicating a need for further research to validate these alternative models in improving PrEP delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. Kamitani, E., Mizuno, Y., DeLuca, JB., et al.[2023]

In 2019, out of 2481 clients seen at a sexual health center, only 220 (9%) received a referral for HIV pre-exposure prophylaxis (PrEP), highlighting a significant gap in access to this preventive treatment.

The study found that the 'warm handoff' referral method, where clients were scheduled for appointments face-to-face with a navigator, resulted in a much higher attendance rate (81%) for initial PrEP visits compared to other methods, indicating that personal engagement is crucial for improving PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an HIV Pre-Exposure Prophylaxis Referral System: From Sexual Health Center to Federally Qualified Health Center Pre-Exposure Prophylaxis Clinic. Lillis, R., Beckford, J., Fegley, J., et al.[2022]

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]

The PrIDE project, which ran from 2016 to 2019, successfully implemented a hybrid model of PrEP navigation that combined patient, peer, and systems navigation, leading to effective linking of clients to PrEP and social services across 12 health departments.

Having all PrEP services located in one place significantly boosted PrEP uptake, while challenges such as staff turnover and lack of health insurance were identified, with payment assistance shown to enhance client PrEP use in areas with insurance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. Salabarría-Peña, Y., Douglas, C., Brantley, M., et al.[2022]

The proposed PrEP continuum of care outlines nine essential steps for effective HIV prevention, from identifying high-risk individuals to ensuring they remain engaged in PrEP care, which is crucial for measuring program implementation progress.

The framework also categorizes PrEP retention into four distinct groups, helping researchers and practitioners assess awareness, uptake, adherence, and retention, ultimately improving the effectiveness of PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the HIV pre-exposure prophylaxis care continuum. Nunn, AS., Brinkley-Rubinstein, L., Oldenburg, CE., et al.[2021]

The 'I Am Men's Health' program successfully improved adherence to PrEP among 23 young men of color at high risk for HIV, achieving an average adherence rate of 73% over a 28-week period.

This innovative approach to promoting PrEP adherence may serve as a model for future large-scale HIV prevention efforts, particularly in communities with high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. Daughtridge, GW., Conyngham, SC., Ramirez, N., et al.[2022]

References

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

Putting PrEP into Practice: Lessons Learned from Early-Adopting U.S. Providers' Firsthand Experiences Providing HIV Pre-Exposure Prophylaxis and Associated Care. [2022]

2. 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]

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

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. [2023]

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

Evaluation of an HIV Pre-Exposure Prophylaxis Referral System: From Sexual Health Center to Federally Qualified Health Center Pre-Exposure Prophylaxis Clinic. [2022]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Defining the HIV pre-exposure prophylaxis care continuum. [2021]

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

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. [2022]