What this study is
During this 5-year study, stepped-care adaptive interventions will be deployed in three rural syringe service programs in a Sequential Multiple Assignment Randomized Trial (SMART) design to test the optimal intervention pathways for HIV PrEP uptake, defined as PrEP initiation (measured by dispensed prescription for oral PrEP) and persistence in PrEP care (measured by refill verification and biomarker confirmation). The study will be accomplished through three Specific Aims. AIM 1: Compare the relative effectiveness of adaptive interventions (AIs) that begin with Peer-led SBCM-PrEP versus those that begin with CDC-PrEP education plus text messaging (TM) on patient-level PrEP care outcomes (initiation and persistence) at 1-, 3- and 6-months; AIM 2: Estimate and rank the effectiveness of four embedded AIs on PrEP care outcomes at 3- and 6-months: (1) CDC-PrEP education, continue TM for responders, add Mobile Outreach for non-responders (NR); (2) CDC-PrEP education, continue TM for responders, add Peer transitional SBCM for NR; (3) Peer-led SBCM-PrEP, continue TM for responders, add Mobile Outreach for NR; (4) Peer-led SBCM-PrEP, continue TM for responders, add Peer transitional SBCM for NR. AIM 3: Across interventions, examine the effects of age, baseline injection frequency, perceived HIV risk, PrEP interest, SSP utilization patterns, and other factors, in predicting PrEP care outcomes at 1-, 3- and 6-months to inform optimally-tailored intervention strategy recommendations.
What's being tested
- SBCM-PrEP + Text Messaging
Intervention · BEHAVIORAL
Two sessions Strengths-Based Case Management intervention adapted for HIV PrEP related educational content delivered to individual clients in the syringe service program setting
- CDC-PrEP + Text Messaging
Intervention · BEHAVIORAL
1 session PrEP education based on CDC guidelines delivered to individual clients in syringe service program settings
- T-SBCM
Intervention · BEHAVIORAL
Up to two post-linkage sessions of SBCM delivered by a peer support specialist in a format of the participants' choice (onsite, virtual/phone) in study month 2
- Mobile Outreach
Intervention · BEHAVIORAL
Up to two in-person field session visits will be conducted by a peer support specialist for the purpose of offering direct support to arrange joint activities for overcoming identified barriers (e.g., transportation) to PrEP care initiation in study month 2.
Study details
- Official title
- Optimizing PrEP Care Delivery Through Adaptive Intervention Strategies for Underserved Rural People Who Inject Drugs
- Sponsor
- Hilary L Surratt, PhD
- Conditions
- HIV Prevention
- Enrolling
- 424 people
- Starts
- 2025-05-14
- Est. completion
- 2029-01
- Design
- Open-label, randomized, sequential groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Self-report of at least one occasion of injection drug use in the past month
- Use of the SSP in the past 30 days
- Expressed willingness to participate in a multi-session intervention and follow-up
- Having an indication for PrEP in the past 6 months based on CDC guidelines
You can't join if
- Being HIV positive
- Current PrEP care
- Self-reported severe renal impairment and/or chronic HBV infection
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openKnox County Health Department
Barbourville, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Clay County Health Department
Manchester, Kentucky, United States
Madison County Health Department
Richmond, Kentucky, United States
Study team
Sponsor
Hilary L Surratt, PhD
Study ID 98939
Principal investigator
Hillary L Surratt, PhD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.