RECRUITINGINTERVENTIONAL
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
About 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. .
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form
Aim 3:
1. Currently employed at one of the participating study sites
2. Willing to complete a web-based survey
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
Contingency 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).
Locations (6)
Recovery Network of Programs, Inc
Bridgeport, Connecticut, United States
Liberations Program, Inc
Bridgeport, Connecticut, United States
Apex Community Care. Inc.
Danbury, Connecticut, United States
Greater Hartford Harm Reduction Coalition- SWAN
New Haven, Connecticut, United States
APT
New Haven, Connecticut, United States
Stanley Street Treatment and Resource Center
Fall River, Massachusetts, United States