Contingency Management for HIV Prevention
(CoMPASS Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byE. Jennifer Edelman, MD, MHS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must not be taking: PrEP
Disqualifiers: Pregnancy, Kidney disease, others
No Placebo Group
Approved in 4 Jurisdictions
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.
12345How 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.
13678Eligibility 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
+6 more
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.
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)Experimental Treatment1 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 Control1 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, 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Liberations Program, IncBridgeport, CT
Stanley Street Treatment and Resource CenterFall River, MA
APTNew Haven, CT
Greater Hartford Harm Reduction Coalition- SWANNew Haven, CT
Loading ...
Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Putting PrEP into Practice: Lessons Learned from Early-Adopting U.S. Providers' Firsthand Experiences Providing HIV Pre-Exposure Prophylaxis and Associated Care. [2022]Optimizing access to HIV pre-exposure prophylaxis (PrEP), an evidence-based HIV prevention resource, requires expanding healthcare providers' adoption of PrEP into clinical practice. This qualitative study explored PrEP providers' firsthand experiences relative to six commonly-cited barriers to prescription-financial coverage, implementation logistics, eligibility determination, adherence concerns, side effects, and anticipated behavior change (risk compensation)-as well as their recommendations for training PrEP-inexperienced providers. U.S.-based PrEP providers were recruited via direct outreach and referral from colleagues and other participants (2014-2015). One-on-one interviews were conducted in person or by phone, transcribed, and analyzed. The sample (n = 18) primarily practiced in the Northeastern (67%) or Southern (22%) U.S. Nearly all (94%) were medical doctors (MDs), most of whom self-identified as infectious disease specialists. Prior experience prescribing PrEP ranged from 2 to 325 patients. Overall, providers reported favorable experiences with PrEP implementation and indicated that commonly anticipated problems were minimal or manageable. PrEP was covered via insurance or other programs for most patients; however, pre-authorization requirements, laboratory/service provision costs, and high deductibles sometimes presented challenges. Various models of PrEP care and coordination with other providers were utilized, with several providers highlighting the value of clinical staff support. Eligibility was determined through joint decision-making with patients; CDC guidelines were commonly referenced but not considered absolute. Patient adherence was variable, with particularly strong adherence noted among patients who had actively sought PrEP (self-referred). Providers observed minimal adverse effects or increases in risk behavior. However, they identified several barriers with respect to accessing and engaging PrEP candidates. Providers offered a wide range of suggestions regarding content, strategy, and logistics surrounding PrEP training, highlighting sexual history-taking and sexual minority competence as areas to prioritize. These insights from early-adopting PrEP providers may facilitate adoption of PrEP into clinical practice by PrEP-inexperienced providers, thereby improving access for individuals at risk for HIV.
Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]Pre-exposure prophylaxis (PrEP) for HIV prevention requires engagement throughout the PrEP care continuum. Using data from a PrEP navigation program, we examine reasons for PrEP discontinuation.
Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. [2023]To identify types, evidence, and study gaps of alternative HIV preexposure prophylaxis (PrEP) care delivery models in the published literature.
Evaluation of an HIV Pre-Exposure Prophylaxis Referral System: From Sexual Health Center to Federally Qualified Health Center Pre-Exposure Prophylaxis Clinic. [2022]Innovative delivery strategies are needed to facilitate access to HIV pre-exposure prophylaxis (PrEP). The objective of this study was to evaluate a navigator-facilitated PrEP referral process from a sexual health center (SHC) to a co-located PrEP clinic as an alternative delivery model. Electronic health record (EHR) data were used to calculate the number of clients seen at the SHC in 2019. Charts were manually reviewed to determine whether a PrEP clinic referral was made and document type of referral method: face-to-face appointment scheduling with the navigator (warm handoff), EHR messaging to navigator to schedule the appointment at a later time (EHR message), or provision of navigator's contact information to the client (card only). In 2019, 2481 unique potentially PrEP-eligible clients were seen at the SHC; 220 (9%) received a PrEP referral. Of referred clients, median age was 30 years (interquartile range, 24-34), 182 (83%) were male, 89 (40%) were non-Hispanic Black, and 24 (11%) were Latinx. In total, 94/220 (43%) referred clients attended an initial PrEP visit with a provider, and the proportion attending by referral method was 81%, 36%, and 27% for warm handoff, EHR message, and card only, respectively (p < 0.0001). Despite co-location of these two clinics, there were significant drop-offs along the PrEP care continuum for this referral system. Warm handoff was the most effective referral method, but further efforts are needed to understand barriers to referral. Implementation of same-day PrEP services at SHCs is one potential solution to engaging additional clients.
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]In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting.
Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. [2022]The PrEP (pre-exposure prophylaxis) Implementation, Data to Care and Evaluation (PrIDE) demonstration project funded 12 health departments (HD) (2016-2019) to scale up PrEP among sexual minorities at risk for HIV. Each health department (HD) conducted an evaluation of at least one local strategy, and, to maximize crossvalidation, an adapted cluster evaluation approach was employed. As a result, five HDs with similar evaluation questions regarding PrEP navigation were identified. Overall, PrEP navigation fit in well with HD clinics and community-based organizations. A hybrid model of patient, peer, and systems navigation linking clients to PrEP and social services was commonly used. Although there were no differences by setting regarding linking clients to PrEP providers, one HD demonstrated that having all PrEP services in the same location contributed the most to PrEP uptake. Navigator skill for case management and rapport building facilitated navigation, whereas staff turnover and lack of client health insurance were challenges. While one HD in a non-Medicaid expansion state was affected by health insurance issues the most, another HD demonstrated that providing payment assistance increased client PrEP use. The findings pinpoint PrEP navigation hybrid modality and having health insurance as promising strategies to increase PrEP uptake among priority groups.
Defining the HIV pre-exposure prophylaxis care continuum. [2021]Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy. There is little scientific consensus about how to measure PrEP program implementation progress. We draw on several years of experience in implementing PrEP programs and propose a PrEP continuum of care that includes: (1) identifying individuals at highest risk for contracting HIV, (2) increasing HIV risk awareness among those individuals, (3) enhancing PrEP awareness, (4) facilitating PrEP access, (5) linking to PrEP care, (6) prescribing PrEP, (7) initiating PrEP, (8) adhering to PrEP, and (9) retaining individuals in PrEP care. We also propose four distinct categories of PrEP retention in care that include being: (1) indicated for PrEP and retained in PrEP care, (2) indicated for PrEP and not retained in PrEP care, (3) no longer indicated for PrEP, and (4) lost to follow-up for PrEP care. This continuum of PrEP care creates a framework that researchers and practitioners can use to measure PrEP awareness, uptake, adherence, and retention. Understanding each point along the proposed continuum of PrEP care is critical for developing effective PrEP interventions and for measuring public health progress in PrEP program implementation.
I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. [2022]In 2012, the US Food and Drug Administration approved Truvada as a pre-exposure prophylaxis (PrEP) for adults at risk of HIV. PrEP is highly effective at preventing HIV when taken daily, but no gold standard exists for consistently administering PrEP to populations at highest risk. The "I Am Men's Health" program used an innovative methodology to generate adherence to PrEP in 23 mostly young men who have sex with men of color (yMSMc), during a 28-week period from February to September 2013. Adherence was measured using weekly medication pickup rates. The average age of the participants was 21 years, and the majority were black and lived below the poverty line. Time on PrEP ranged from 1 to 28 weeks (2723 person-days), and the weighted average adherence was 73%. The methodology used in this study was preliminarily effective at generating adherence to PrEP among high-risk yMSMc in a community setting and may help inform large-scale future HIV prevention interventions.