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

Enrolling By InvitationNA

Sponsor: Hilary L Surratt, PhD

Conditions: HIV Prevention

Interventions: SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging, T-SBCM, Mobile Outreach

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* being HIV positive
* current PrEP care
* self-reported severe renal impairment and/or chronic HBV infection

Locations (4)

Barbourville, Kentucky, United States
Lexington, Kentucky, United States
Manchester, Kentucky, United States
Richmond, Kentucky, United States