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

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.

Conditions

• HIV Prevention

Interventions

BEHAVIORAL

SBCM-PrEP + Text Messaging

Two sessions Strengths-Based Case Management intervention adapted for HIV PrEP related educational content delivered to individual clients in the syringe service program setting

BEHAVIORAL

CDC-PrEP + Text Messaging

1 session PrEP education based on CDC guidelines delivered to individual clients in syringe service program settings

BEHAVIORAL

T-SBCM

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

BEHAVIORAL

Mobile Outreach

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Hilary L Surratt, PhD

  lead OTHER

Principal Investigators

• Hillary L Surratt, PhD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-14

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• United States

Study Locations