Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
Study Details
Study Description
Brief Summary
The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CDC-PrEP 1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting |
Behavioral: CDC-PrEP
1 session PrEP education following CDC guidelines
|
| Experimental: SBCM-PrEP Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting |
Behavioral: SBCM-PrEP
Multi-session SBCM intervention adapted for PrEP initiation focus
|
Outcome Measures
Primary Outcome Measures
- Number of participants initiating PrEP [3 months post-baseline]
Documented PrEP initiation, measured by dispensed PrEP prescription.
- Number of participants initiating PrEP [6 months post-baseline]
Documented PrEP initiation, measured by dispensed PrEP prescription.
Secondary Outcome Measures
- Level of Intervention Engagement assessed by session checklist [8 weeks post-baseline]
5 item Session Checklist completed by Nurse-Interventionist post-session; range is 0-15, higher scores are higher engagement
- Level of Intervention Satisfaction assessed by the IAQ [8 weeks post-baseline]
8 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 0-32, higher scores are higher satisfaction
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years or older;
-
HIV-negative status;
-
Past month drug injection;
-
Client of SSP in targeted sites
Exclusion Criteria:
• HIV-positive status
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Hilary L Surratt, PhD
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Hilary L Surratt, PhD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 67933
- R34DA053140