HIV Prevention Program, Opioid-use Disorder
Conditions
Keywords
People who inject drugs, Pre-exposure prophylaxis (PrEP), Medications for opioid use disorder, Opioid use disorder, HIV prevention
Brief summary
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. .
Detailed description
Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) vs. treatment as usual (TAU) on HIV risk reduction among individuals with opioid use disorder (OUD) who have injected drugs in their lifetime. The study will be conducted in community-based settings serving individuals with opioid use disorder to assess the effectiveness of CoMPASS on promoting: sustained PrEP adherence (primary outcome) and HIV risk behaviors, engagement in opioid use disorder-related care, opioid use (secondary outcomes); and sexually transmitted infections and HIV (exploratory). Participants randomized to CoMPASS will first receive contingency management and have the potential to earn prizes for making progress towards initiation of and consistent adherence to HIV pre-exposure prophylaxis (PrEP) and engagement in OUD-related care. Individuals who do not demonstrate PrEP adherence (based on self-report, confirmed by urine testing for tenofovir metabolites at week 12), will be "stepped up" to PrEP Adherence and Support Services (PASS). The intervention is 24 weeks in duration. 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. To inform future implementation efforts, factors relevant for scale-up in parallel (e.g., completion of study visits, attitudes regarding the intervention among front-line staff) will be assessed.
Interventions
BEHAVIORALContingency Management with stepped care to PrEP adherence and support services (CoMPASS)
Participants will 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).
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Aims 1 and 2: Randomized controlled trial to evaluate the effectiveness of contingency management with stepped care to PrEP adherence and support services (Compass) compared to treatment as usual. Aim 3: Implementation-focused process evaluation to gain information on implementation of the intervention from perspectives of participants as well as front-line providers and staff
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aims 1 and 2: 1. Receive or willing to receive care at one of the participating study sites 2. Have a recent negative HIV test with no concern for acute HIV 3. Report injection drug use in their lifetime 4. Meet PrEP eligibility criteria by either a) sharing of injection or drug preparation equipment; b) sexual risk behaviors (i.e. condomless sex or STI) in the past 6 months 5. Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder 6. Have a phone or use of a household member's phone 7. Provide written informed consent Aim 3: 1. Currently employed at one of the participating study sites 2. Willing to complete a web-based survey
Exclusion criteria
Aims 1 and 2: 1. Currently prescribed PrEP 2. Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive 3. Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.) 4. Inability to provide at least one collateral contact for a friend or family member. 5. Non-English speaking (for sites without Spanish-speaking staff) 6. Have kidney disease (a contraindication to PrEP) Aim 3: 1\. Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained PrEP adherence | 24 weeks | Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained PrEP adherence | 12 weeks | Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation. |
| Recent PrEP adherence | 12 weeks | Self-report adherence confirmed by the presence of tenofovir in urine sample or objective confirmation. |
| HIV Risk Behaviors | 12 weeks | Self-reported HIV risk behaviors |
| Engagement in opioid use disorder-related care | 12 weeks | Self report of engagement in opioid use disorder-related care |
| Extra medical opioid use | 12 weeks | Self reported extra medical opioid use |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORE. Jennifer Edelman, MD, MHS
Yale University
Outcome results
None listed