Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Connecticut
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- HIV risk reduction skills assessment at baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
single blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •cannot attend all study sessions
- •actively homicidal and/or suicidal
Arms & Interventions
Control arm with standard intervention
Participants will complete a 4-week CHRP-BB standard intervention
Intervention: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) (Behavioral)
Experimental arm with enhanced intervention
Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.
Intervention: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) (Behavioral)
Outcomes
Primary Outcomes
HIV risk reduction skills assessment at baseline
Time Frame: pre intervention (week 0)
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
number of participants who picked up PrEP prescription
Time Frame: post intervention (week 4)
PrEP prescription filled by pharmacy
HIV risk reduction skills assessment, post intervention
Time Frame: post intervention (week 4)
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
Secondary Outcomes
- number of participants retained throughout study(post intervention (week 4))
- Intervention Acceptability(post intervention (week 4))
- number of participants recruited(pre intervention (week 0))
Investigators
Michael Copenhaver
Professor
University of Connecticut