Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs
1 other identifier
interventional
50
1 country
1
Brief Summary
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence. Fifty people who inject drugs (PWID) were prescribed PrEP and randomized to one of two conditions, Twenty-five PWID participated in a standard HIV prevention session and 25 other PWID participated in a HIV prevention session with the included accommodation strategies. At recruitment participants were asked to provide self-report of the screening form and cognitive functioning. The intervention consisted of a total of 5 sessions: 1 meeting to gain baseline information of participants and 4 intervention sessions. Participants completed the consent form, demographics, skills assessment, drug use behavior assessment, and HIV risk behavior assessment at the pre-interview meeting. Participants completed PrEP uptake assessments and skills assessments immediately following the intervention to compare the pre/post results between the two groups. All participants also completed an acceptability rating to help researchers determine the acceptability of the accommodation strategies used, at the end of the 4th session. The objective was to determine if the proposed accommodation strategies are feasible and efficacious at improving HIV prevention outcomes, including knowledge and skills. Information gleaned from this process will be used to refine the intervention approach for future testing and implementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2022
CompletedFirst Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedJune 22, 2023
June 1, 2023
3 months
June 1, 2023
June 12, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
HIV risk reduction skills assessment at baseline
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
pre intervention (week 0)
HIV risk reduction skills assessment, post intervention
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
post intervention (week 4)
number of participants who picked up PrEP prescription
PrEP prescription filled by pharmacy
post intervention (week 4)
Secondary Outcomes (3)
number of participants recruited
pre intervention (week 0)
number of participants retained throughout study
post intervention (week 4)
Intervention Acceptability
post intervention (week 4)
Study Arms (2)
Control arm with standard intervention
ACTIVE COMPARATORParticipants will complete a 4-week CHRP-BB standard intervention
Experimental arm with enhanced intervention
EXPERIMENTALParticipants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.
Interventions
CHRP-BB is an evidence-informed behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. CHRP-BB consists of 4 weekly 50- minute sessions.
The enhanced version of CHRP-BB is an adapted behavioral intervention for HIV prevention among high-risk drug users in treatment on PrEP. This intervention consists of 4 weekly 50- minute sessions that include cognitive dysfunction accommodation strategies.
Eligibility Criteria
You may qualify if:
- at least 18 years or older
- reported injection drug use in the past 30 days
- reported engagement in drug- and/or sex- related HIV risk behaviors
- HIV negative
- are willing to initiate PrEP use
- can communicate (read, write and speak) in English
- experience mild/moderate level of cognitive dysfunction
You may not qualify if:
- cannot attend all study sessions
- actively homicidal and/or suicidal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
APT Foundation
New Haven, Connecticut, 06519, United States
Related Publications (1)
Mistler CB, Shrestha R, Copenhaver MM. Testing the feasibility, acceptability, and preliminary efficacy of integrating accommodation strategies into an HIV prevention intervention for people who inject drugs with cognitive dysfunction. J Subst Use Addict Treat. 2025 Feb;169:209582. doi: 10.1016/j.josat.2024.209582. Epub 2024 Nov 17.
PMID: 39551147DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Copenhaver, PhD
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 22, 2023
Study Start
September 7, 2022
Primary Completion
December 12, 2022
Study Completion
December 12, 2022
Last Updated
June 22, 2023
Record last verified: 2023-06