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Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services (CoMPASS)

Primary Purpose

Opioid-use Disorder, HIV Prevention Program

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring People who inject drugs, Pre-exposure prophylaxis (PrEP), Medications for opioid use disorder, Opioid use disorder, HIV prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 the past 6 months
  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 cell phone or use of a household member's cell 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

Sites / Locations

  • Recovery Network of Programs, IncRecruiting
  • Liberations Program, IncRecruiting
  • Apex Community Care. Inc.Recruiting
  • Greater Hartford Harm Reduction Coalition- SWANRecruiting
  • APTRecruiting
  • Stanley Street Treatment and Resource CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual (TAU)

Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Sustained PrEP adherence
Determined by tenovifir-diphosphate levels by dried blood spot testing.

Secondary Outcome Measures

Sustained PrEP adherence
Determined by tenovifir-diphosphate levels by dried blood spot testing. .
Recent PrEP adherence
Self-report adherence confirmed by the presence of tenofivir in urine sample.
HIV Risk Behaviors
Self-reported HIV risk behaviors
HIV Risk Behaviors
Self-reported HIV risk behaviors
Engagement in opioid use disorder-related care
Self report of engagement in opioid use disorder-related care
Engagement in opioid use disorder-related care
Self report of engagement in opioid use disorder-related care
Extra medical opioid use
Self reported extra medical opioid use
Extra medical opioid use
Self reported extra medical opioid use

Full Information

First Posted
January 29, 2021
Last Updated
March 7, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04738825
Brief Title
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Acronym
CoMPASS
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 inject drugs. 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 inject drugs. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
526 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sustained PrEP adherence
Description
Determined by tenovifir-diphosphate levels by dried blood spot testing.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Sustained PrEP adherence
Description
Determined by tenovifir-diphosphate levels by dried blood spot testing. .
Time Frame
12 weeks
Title
Recent PrEP adherence
Description
Self-report adherence confirmed by the presence of tenofivir in urine sample.
Time Frame
12 weeks
Title
HIV Risk Behaviors
Description
Self-reported HIV risk behaviors
Time Frame
12 weeks
Title
HIV Risk Behaviors
Description
Self-reported HIV risk behaviors
Time Frame
24 weeks
Title
Engagement in opioid use disorder-related care
Description
Self report of engagement in opioid use disorder-related care
Time Frame
12 weeks
Title
Engagement in opioid use disorder-related care
Description
Self report of engagement in opioid use disorder-related care
Time Frame
24 weeks
Title
Extra medical opioid use
Description
Self reported extra medical opioid use
Time Frame
12 weeks
Title
Extra medical opioid use
Description
Self reported extra medical opioid use
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Sexually transmitted infection and HIV acquisition
Description
State surveillance data
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aims 1 and 2: Receive or willing to receive care at one of the participating study sites Have a recent negative HIV test with no concern for acute HIV Report injection drug use in the past 6 months 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 Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder Have a cell phone or use of a household member's cell phone Provide written informed consent Aim 3: Currently employed at one of the participating study sites Willing to complete a web-based survey Exclusion criteria: Aims 1 and 2: Currently prescribed PrEP Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.) Inability to provide at least one collateral contact for a friend or family member. Non-English speaking (for sites without Spanish-speaking staff) Have kidney disease (a contraindication to PrEP) Aim 3: 1. Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
June-Marie C Weiss, MA, MEd
Phone
203-737-3347
Email
junemarie.weiss@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Jennifer Edelman, MD, MHS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Recovery Network of Programs, Inc
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Kolakowski, LCSW
Facility Name
Liberations Program, Inc
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Montgomery
Facility Name
Apex Community Care. Inc.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albana Lame, MS
Facility Name
Greater Hartford Harm Reduction Coalition- SWAN
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaclyn Lucibello
Phone
475-221-6645
First Name & Middle Initial & Last Name & Degree
Mark Jenkins
Facility Name
APT
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Madden
Facility Name
Stanley Street Treatment and Resource Center
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genie L Bailey, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services

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