Clinical trial NCT04738825: Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Official title: Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
HIV Prevention Program
Keywords: People who inject drugs
Pre-exposure prophylaxis (PrEP)
Medications for opioid use disorder
Opioid use disorder
HIV prevention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-02-04
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained PrEP adherence
timeFrame: 24 weeks
Secondary outcomes:
measure: Sustained PrEP adherence
timeFrame: 12 weeks
measure: Recent PrEP adherence
timeFrame: 12 weeks
measure: HIV Risk Behaviors
timeFrame: 12 weeks
measure: HIV Risk Behaviors
timeFrame: 24 weeks
measure: Engagement in opioid use disorder-related care
timeFrame: 12 weeks
measure: Engagement in opioid use disorder-related care
timeFrame: 24 weeks
measure: Extra medical opioid use
timeFrame: 12 weeks
measure: Extra medical opioid use
timeFrame: 24 weeks
Other outcomes:
measure: Sexually transmitted infection and HIV acquisition
timeFrame: 12 months
Locations:
city: Bridgeport
country: United States
facility: Recovery Network of Programs, Inc
state: Connecticut
city: Bridgeport
country: United States
facility: Liberations Program, Inc
state: Connecticut
city: Danbury
country: United States
facility: Apex Community Care. Inc.
state: Connecticut
city: New Haven
country: United States
facility: Greater Hartford Harm Reduction Coalition- SWAN
state: Connecticut
city: New Haven
country: United States
facility: APT
state: Connecticut
city: Fall River
country: United States
facility: Stanley Street Treatment and Resource Center
state: Massachusetts
Study officials:
affiliation: Yale University
name: E. Jennifer Edelman, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: