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

NCT ID: NCT05669534

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2027-01-01

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Hiv Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Multiphase Optimization Strategy
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Condition 1

Standard CHRP Intervention Components

Group Type ACTIVE_COMPARATOR

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 2

Standard CHRP Intervention Components and Information Processing Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 3

Standard CHRP Intervention Components and Memory Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 4

Standard CHRP Intervention Components, Information Processing Components, and Memory Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 5

Standard CHRP Intervention Components, Executive Functioning Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 6

Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 7

Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 8

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 9

Standard CHRP Intervention Components and Attention Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 10

Standard CHRP Intervention Components, Information Processing Components, and Attention Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 11

Standard CHRP Intervention Components, Memory Components, and Attention Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 12

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 13

Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 14

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 15

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Condition 16

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Group Type EXPERIMENTAL

community-friendly health recovery program

Intervention Type BEHAVIORAL

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

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Intervention Type DRUG

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

Interventions

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community-friendly health recovery program

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

Intervention Type BEHAVIORAL

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

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

Intervention Type DRUG

Other Intervention Names

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CHRP PrEP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Michael Copenhaver

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Copenhaver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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APT Foundation

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brian Sibilio, BS

Role: CONTACT

[email protected]
2037814690

Tanya Adler, MS

Role: CONTACT

[email protected]
2037814690

Facility Contacts

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Brian Sibilio, BS

Role: primary

[email protected]
203-781-4690

References

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Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688.

Reference Type DERIVED
PMID: 37399447 (View on PubMed)

Other Identifiers

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H22-0121

Identifier Type: -

Identifier Source: org_study_id

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