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HIV PreventionNCT06666309

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

A study testing SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging and T-SBCM in people with HIV Prevention, run by Hilary L Surratt, PhD at 4 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Prevention
What is being tested?
SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging and T-SBCM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
4 sitesUnited States
Study dates
14 May 2025to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites

  • Knox County Health Department

    Barbourville, Kentucky, 40906

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Clay County Health Department

    Manchester, Kentucky, 40962

  • Madison County Health Department

    Richmond, Kentucky, 40475

Other trials in United States

About this study

Official title: Optimizing PrEP Care Delivery Through Adaptive Intervention Strategies for Underserved 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.

Read the detailed description

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

Conditions
HIV Prevention
Being tested
SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging, T-SBCM, Mobile Outreach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBCM-PrEP + Text MessagingBehavioural

    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 MessagingBehavioural

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

  • T-SBCMBehavioural

    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 OutreachBehavioural

    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 groups in NCT06666309
Study groupRoleWhat they receive
Strengths Based Case Management - PrEP + Text MessagingExperimentalTwo session Strengths-based Case Management intervention delivered by a peer support specialist to individual clients in the syringe service program
Receives: Behavioral: SBCM-PrEP + Text Messaging
CDC-PrEP + Text MessagingActive comparator1 session PrEP education following CDC guidelines delivered to individual clients in the syringe service program
Receives: Behavioral: CDC-PrEP + Text Messaging
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
Receives: Behavioral: SBCM-PrEP + Text Messaging; Behavioral: T-SBCM
Strengths Based Case Management - PrEP + Text Messaging + Mobile outreachExperimentalSBCM-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
Receives: Behavioral: SBCM-PrEP + Text Messaging; Behavioral: Mobile Outreach
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
Receives: Behavioral: CDC-PrEP + Text Messaging; Behavioral: T-SBCM
CDC-PrEP + Text Messaging + Mobile outreachOtherCDC-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
Receives: Behavioral: CDC-PrEP + Text Messaging; Behavioral: Mobile Outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants initiating PrEP

    Documented PrEP initiation, measured by dispensed prescription

    Measured: 1 month post-baseline

  2. Number of participants initiating PrEP

    Documented PrEP initiation, measured by dispensed prescription

    Measured: 3 months post-baseline

  3. Number of participants initiating PrEP

    Documented PrEP initiation, measured by dispensed prescription

    Measured: 6 month post-baseline

Secondary outcomes (7)

  1. Linkage to PrEP Care

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

    Measured: 1 month post-baseline

  2. Linkage to PrEP Care

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

    Measured: 3 month post-baseline

  3. Linkage to PrEP Care

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

    Measured: 6 month post-baseline

  4. PrEP Persistence

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

    Measured: 3 months post-baseline

  5. PrEP Persistence

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

    Measured: 6 months post-baseline

  6. PrEP Adherence

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

    Measured: 3 months post-baseline

  7. PrEP Adherence

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

    Measured: 6 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start14 May 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666309
Sponsor's protocol ID
98939
Other IDs
R01DA061996-01
Status last verified
May 2026
First submitted
29 Oct 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging and T-SBCM in people with HIV Prevention, run by Hilary L Surratt, PhD at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants initiating PrEP (time frame: 1 month post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06666309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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