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Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP

Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05669534
Acronym
MOST
Enrollment
256
Registered
2023-01-03
Start date
2023-03-01
Completion date
2027-01-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Opioid Use Disorder

Keywords

people who inject drugs, HIV, cognitive dysfunction, pre-exposure prophylaxis, multiphase optimization strategy, medication for opioid use disorder, opioid use disorder

Brief summary

The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).

Detailed description

Participants will be randomized to one of 16 conditions. In addition to receiving the Core Components of the CHRP behavioral intervention, participants will receive one of the sixteen combinations of four compensatory components that show promise in terms of enhancing the ability to process and utilize HIV prevention content (see conceptual figure above), and that are not currently part of CHRP. The Attention Component includes: (a) Increasing frequency of sessions (more than once per week); (b) Distributed practice (spreading out information across sessions); (c) More structured sessions (well-organized objectives shared with patients); (d) Introducing new information during closure (foreshadow content of next session). The Executive Function Component includes the following strategies: (a) Associating behavior with situational cues (anticipate risky situations); (b) Linking actions to a triggering cue (storytelling techniques using imagery); (c) Planning (identify and organize steps required to meet goal) and (d) Valuing future events (recognize the benefits of drug treatment). Similarly, the Memory Component involves: (a) Memory aids (reminders and cues to be used between sessions); (b) Summarizing/reiterating information (frequent review throughout sessions); (c) Prospective memory (emphasize routine, develop cues, elaborate on positive behaviors); and (d) Environmental engineering (prepare for adverse events). Lastly, the Information Processing Component includes: (a) Mixed methods of presentation (verbal, visual, and hands-on); (b) Simple language (clear, concrete examples aligned with health literacy level); (c) Present content slowly (allow extra time for responses); and (d Immediate feedback following assessment (oral/ written).Of particular note, the investigators are using this framework to examine all combinations of these components (rather than merely testing all four) to promote ecological validity and future implementation. Specifically, our approach will help determine the most resource-efficient intervention, as there are many barriers to adding components to standard of care in these clinical settings. For example, if components targeting only two domains can produce equivalent outcomes as components targeting four, the former would be identified as preferred

Interventions

Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.

DRUGPre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.

Sponsors

University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Multiphase Optimization Strategy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* being 18 years or older * meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc. * showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening * having initiated Pre-Exposure Prophylaxis (PrEP) within the past week * confirming HIV-negative status through proof of PrEP prescription * reporting unsafe injection drug use practices or unprotected sex within the past 3 months * having a cell phone * being able to read and understand in English

Exclusion criteria

* unable to provide consent * actively suicidal * actively homicidal * actively psychotic * display MoCA scores suggestive of dementia

Design outcomes

Primary

MeasureTime frameDescription
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)PrEP adherence DBS measured at week 4Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Pre-Exposure Prophylaxis Adherence via pharmacy refill dataPrEP adherence pharmacy refill data measured at week 4Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy
Pre-Exposure Prophylaxis Adherence via self-report scalePrEP adherence pharmacy self report measured at week 4Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

Secondary

MeasureTime frameDescription
HIV risk behaviors questionnaireHIV risk behaviors measured at Week 1Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
HIV prevention IMB model constructs questionnaireHIV prevention IMB model constructs measured at Week 1self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills

Countries

United States

Contacts

CONTACTBrian Sibilio, BS
brian.sibilio@uconn.edu2037814690
CONTACTTanya Adler, MS
tanya.adler@uconn.edu2037814690
PRINCIPAL_INVESTIGATORMichael Copenhaver, PhD

University of Connecticut

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026