Adaptive Intervention Strategies for HIV PrEP Care in Rural People Who Inject Drugs

Part of paid clinical trials in Barbourville, Kentucky.

Sponsor
Hilary L Surratt, PhD
Study ID
NCT06666309
Status
Enrolling By Invitation

Conditions

  • HIV Prevention

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SBCM-PrEP + Text Messaging — 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 — BEHAVIORAL
    1 session PrEP education based on CDC guidelines delivered to individual clients in syringe service program settings
  • T-SBCM — 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 — 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

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.

Key Dates

Start date
May 14, 2025
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
424 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Strengths Based Case Management - PrEP + Text Messaging
    Two session Strengths-based Case Management intervention delivered by a peer support specialist to individual clients in the syringe service program
  • Active Comparator: CDC-PrEP + Text Messaging
    1 session PrEP education following CDC guidelines delivered to individual clients in the syringe service program
  • Experimental: Strengths Based Case Management - PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)
    SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist
  • Experimental: Strengths Based Case Management - PrEP + Text Messaging + Mobile outreach
    SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist
  • Other: CDC-PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)
    CDC-PrEP + Text Messaging; no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist
  • Other: CDC-PrEP + Text Messaging + Mobile outreach
    CDC-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

Primary Outcome Measure

Number of participants initiating PrEP [ Time Frame: 1 month post-baseline ]

Locations (4)

FacilityCityStateZIPSite coordinators
Knox County Health DepartmentBarbourvilleKentucky40906-
University of KentuckyLexingtonKentucky40536-
Clay County Health DepartmentManchesterKentucky40962-
Madison County Health DepartmentRichmondKentucky40475-

Find similar trials in Barbourville, KY

By research site
Knox County Health Department· Barbourville, KYUniversity of Kentucky· Lexington, KYClay County Health Department· Manchester, KYMadison County Health Department· Richmond, KY

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