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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA057633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Pittsburgh | OTHER |
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The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion services to be delivered in the hospital setting, called the THRIVE intervention.
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
Enhanced usual care participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Intervention | Experimental |
| |
| Enhanced Usual Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Intervention | Behavioral | Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections | Cumulative incidence of non-fatal overdose OR skin and soft tissue infection | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses | Cumulative incidence of non-fatal overdose | Baseline to 6 months |
| Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the THRIVE intervention on change in higher risk infection behaviors (characterized by BIRSI score) compared to EUC | Change in higher risk infection behaviors measured as the total score on the BIRSI | Baseline to 6 months |
| Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (a) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Program Coordinator | Contact | 412-679-9848 | thriving@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline D Wilson, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Mercy Hospital | Not yet recruiting | Pittsburgh | Pennsylvania | 15203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Harm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/ | ||
| 17689353 | Background | Friedman SR, de Jong W, Rossi D, Touze G, Rockwell R, Des Jarlais DC, Elovich R. Harm reduction theory: users' culture, micro-social indigenous harm reduction, and the self-organization and outside-organizing of users' groups. Int J Drug Policy. 2007 Mar;18(2):107-17. doi: 10.1016/j.drugpo.2006.11.006. Epub 2006 Dec 28. | |
| 23623720 |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Enhanced Usual Care | Other | Participants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care. |
|
Cumulative incidence of skin and soft tissue infection |
| Baseline to 6 months |
(a) Change in the proportion of participants who self-report naloxone use in past 30 days to reverse another person's overdose |
| Baseline to 6 months |
| Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (b) | (b) Change in the proportion of participants who self-report currently carrying naloxone | Baseline to 6 months |
| Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (c) | (c) Change in the proportion of participants who self-report using at least one drug checking strategy in the past 30 days | Baseline to 6 months |
| Effectiveness of the THRIVE intervention on health resilience access compared to EUC (a) | (a) Change in the proportion of participants who self-report having received at least one of: naloxone, syringes, or new or unused pipes in past 30 days | Baseline to 6 months |
| Effectiveness of the THRIVE intervention on health resilience access compared to EUC (b) | (b) Change in the proportion of participants who self-report visiting a syringe services program in past 30 days | Baseline to 6 months |
| Effectiveness of the THRIVE intervention on health resilience access compared to EUC (c) | (c) Change in the proportion of participants who self-report receiving any health resilience services from a needle exchange facility in past 30 days | Baseline to 6 months |
| Heterogeneity of treatment effect by race (Black versus white) in the THRIVE intervention arm | Cumulative incidence of non-fatal overdose OR skin or soft tissue infection, by race (Black versus white) | Baseline to 6 months |
| UPMC Presbyterian-Montefiore Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| UPMC Shadyside Hospital | Not yet recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
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| D001519 | Behavior |