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Enrolling by Invitation

NCT Number: NCT06666309

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

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.

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Key information

Conditions

HIV Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Knox County Health Department, Barbourville, Kentucky, United States

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About this study

Kentucky's HIV epidemic displays an especially profound and disproportionate impact among people who inject drugs (PWID): 14.8% of males and 54.2% of females newly diagnosed with HIV in 2021 have an injection drug use-related transmission factor, far exceeding the national average for this exposure category. A central pillar of Ending the HIV Epidemic (EHE) is the prevention of new HIV infections through scale up of Pre-Exposure Prophylaxis (PrEP) in key populations, including PWID. For PWID, PrEP uptake remains severely limited, and no evidence-based PrEP interventions specifically targeted for PWID are available. In the previous pilot in KY's Appalachian region, two brief, low-intensity interventions to promote linkage to co-located PrEP care in rural syringe service programs (SSPs) were successfully implemented, including a newly adapted strengths-based case management (SBCM-PrEP) intervention designed to address multi-level barriers to PrEP initiation. The pilot trial has demonstrated proof of concept for integrated PrEP care within rurally-located SSPs and high acceptability among PWID with high uptake of initial clinical interventions. Nevertheless, just 51% returned for test results, and 28% progressed to PrEP prescription, indicating that augmented intervention support is required to optimize PrEP uptake. The stepped-care Adaptive Interventions (AIs) to be tested respond directly to identified challenges in the pilot trial and the need for augmented support among initial non-responders. AIs have shown remarkable promise in diverse behavioral and medical conditions, including areas such as chronic lower back pain, risky drinking and violent behavior, reducing alcohol use, preventing suicidal behavior, and HIV treatment retention

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants initiating PrEP

    Time frame: 1 month post-baseline

    Documented PrEP initiation, measured by dispensed prescription

  2. Number of participants initiating PrEP

    Time frame: 3 months post-baseline

    Documented PrEP initiation, measured by dispensed prescription

  3. Number of participants initiating PrEP

    Time frame: 6 month post-baseline

    Documented PrEP initiation, measured by dispensed prescription

Secondary outcomes

  1. Linkage to PrEP Care

    Time frame: 1 month post-baseline

    Number of participants completing initial clinical evaluation for PrEP, measured by provider report

  2. Linkage to PrEP Care

    Time frame: 3 month post-baseline

    Number of participants completing initial clinical evaluation for PrEP, measured by provider report

  3. Linkage to PrEP Care

    Time frame: 6 month post-baseline

    Number of participants completing initial clinical evaluation for PrEP, measured by provider report

  4. PrEP Persistence

    Time frame: 3 months post-baseline

    Number of participants receiving dispensed PrEP refill, measured by provider report/pharmacy verification.

  5. PrEP Persistence

    Time frame: 6 months post-baseline

    Number of participants receiving Dispensed PrEP refill, measured by provider report/pharmacy verification.

  6. PrEP Adherence

    Time frame: 3 months post-baseline

    Number of participants with Presence of PrEP (TFV) in blood sample

  7. PrEP Adherence

    Time frame: 6 months post-baseline

    Number of participants with Presence of PrEP (TFV) in blood sample

Sponsors and collaborators

Lead sponsor

Hilary L Surratt, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Optimizing PrEP Care Delivery Through Adaptive Intervention Strategies for Underserved Rural People Who Inject Drugs

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 30, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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