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
2 other identifiers
interventional
424
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedStudy Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
May 11, 2026
May 1, 2026
3.6 years
October 29, 2024
May 7, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants initiating PrEP
Documented PrEP initiation, measured by dispensed prescription
1 month post-baseline
Number of participants initiating PrEP
Documented PrEP initiation, measured by dispensed prescription
3 months post-baseline
Number of participants initiating PrEP
Documented PrEP initiation, measured by dispensed prescription
6 month post-baseline
Secondary Outcomes (7)
Linkage to PrEP Care
1 month post-baseline
Linkage to PrEP Care
3 month post-baseline
Linkage to PrEP Care
6 month post-baseline
PrEP Persistence
3 months post-baseline
PrEP Persistence
6 months post-baseline
- +2 more secondary outcomes
Study Arms (6)
Strengths Based Case Management - PrEP + Text Messaging
EXPERIMENTALTwo session Strengths-based Case Management intervention delivered by a peer support specialist to individual clients in the syringe service program
CDC-PrEP + Text Messaging
ACTIVE COMPARATOR1 session PrEP education following CDC guidelines delivered to individual clients in the syringe service program
Strengths Based Case Management - PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)
EXPERIMENTALSBCM-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
Strengths Based Case Management - PrEP + Text Messaging + Mobile outreach
EXPERIMENTALSBCM-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
CDC-PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)
OTHERCDC-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
CDC-PrEP + Text Messaging + Mobile outreach
OTHERCDC-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
Interventions
Two sessions Strengths-Based Case Management intervention adapted for HIV PrEP related educational content delivered to individual clients in the syringe service program setting
1 session PrEP education based on CDC guidelines delivered to individual clients in syringe service program settings
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
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.
Eligibility Criteria
You 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 may not qualify if:
- being HIV positive
- current PrEP care
- self-reported severe renal impairment and/or chronic HBV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hilary L Surratt, PhDlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (4)
Knox County Health Department
Barbourville, Kentucky, 40906, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Clay County Health Department
Manchester, Kentucky, 40962, United States
Madison County Health Department
Richmond, Kentucky, 40475, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Hillary L Surratt, PhD
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 30, 2024
Study Start
May 14, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
May 11, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The study team will submit a de-identified and cleaned survey and clinical dataset within 12 months after the last participant's study visit, or at acceptance of the primary outcomes paper for publication, whichever is first.
- Access Criteria
- De-identified survey and clinical data will be shared with controlled access in for general research use.
All Aim 1 and 2 de-identified REDCap survey data and clinical data extracts from report forms will be preserved and shared. We will not share participant locator information. Datasets will be shared as CSV files.