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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA051871 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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. .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual (TAU) | No 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) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained PrEP adherence | Determined by tenovifir-diphosphate levels by dried blood spot testing. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained PrEP adherence | Determined by tenovifir-diphosphate levels by dried blood spot testing. . | 12 weeks |
| Recent PrEP adherence | Self-report adherence confirmed by the presence of tenofivir in urine sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Sexually transmitted infection and HIV acquisition | State surveillance data | 12 months |
Inclusion Criteria:
Aims 1 and 2:
Aim 3:
Exclusion criteria:
Aims 1 and 2:
Aim 3:
1. Non-English speaking
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| Name | Affiliation | Role |
|---|---|---|
| E. Jennifer Edelman, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recovery Network of Programs, Inc | Bridgeport | Connecticut | 06484 | United States | ||
| Liberations Program, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39710733 | Derived | Pickering E, Viera A, Sung ML, Davidson D, Bailey G, Buchelli M, Jenkins M, Kolakowski J, Maier L, Edelman EJ, Rash CJ. Readiness to implement contingency management to promote PrEP initiation and adherence among people who inject drugs: results from a multi-site implementation survey. Addict Sci Clin Pract. 2024 Dec 23;19(1):97. doi: 10.1186/s13722-024-00503-4. | |
| 36460267 | Derived | Sung ML, Viera A, Esserman D, Tong G, Davidson D, Aiudi S, Bailey GL, Buchanan AL, Buchelli M, Jenkins M, John B, Kolakowski J, Lame A, Murphy SM, Porter E, Simone L, Paris M, Rash CJ, Edelman EJ. Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs. Contemp Clin Trials. 2023 Feb;125:107037. doi: 10.1016/j.cct.2022.107037. Epub 2022 Nov 30. |
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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
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|
| 12 weeks |
| HIV Risk Behaviors | Self-reported HIV risk behaviors | 12 weeks |
| HIV Risk Behaviors | Self-reported HIV risk behaviors | 24 weeks |
| Engagement in opioid use disorder-related care | Self report of engagement in opioid use disorder-related care | 12 weeks |
| Engagement in opioid use disorder-related care | Self report of engagement in opioid use disorder-related care | 24 weeks |
| Extra medical opioid use | Self reported extra medical opioid use | 12 weeks |
| Extra medical opioid use | Self reported extra medical opioid use | 24 weeks |
| Bridgeport |
| Connecticut |
| 06604 |
| United States |
| Apex Community Care. Inc. | Danbury | Connecticut | 06810 | United States |
| Greater Hartford Harm Reduction Coalition- SWAN | New Haven | Connecticut | 06511 | United States |
| APT | New Haven | Connecticut | 06519 | United States |
| Stanley Street Treatment and Resource Center | Fall River | Massachusetts | 02720 | United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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