NCT06666309Enrolling by invitation
Adaptive Intervention Strategies for HIV PrEP Care in Rural People Who Inject Drugs
Optimizing PrEP Care Delivery Through Adaptive Intervention Strategies for Underserved Rural People Who Inject Drugs
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 424 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 14 May 2025
- Primary completion date
- Jan 2029
- Lead sponsor
- Hilary L Surratt, PhD
- Diseases
- HIV
- NCT number
- NCT06666309
What you commit to
- Study type: Interventional
- Planned participants: 424
- From 14 May 2025 to the primary completion date, Jan 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- being HIV positive
- self-reported severe renal impairment and/or chronic HBV infection
Other
- current PrEP care
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Knox County Health Department Coordinator of this site? Confirm its status | Barbourville | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Clay County Health Department Coordinator of this site? Confirm its status | Manchester | United States | Unknown status |
| Madison County Health Department Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.