Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs

University of Connecticut

Status: Completed

Conditions: Cognitive Dysfunction

Treatments: Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB); Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05912374

H22-0033

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control arm with standard intervention

Active Comparator group

Description:

Participants will complete a 4-week CHRP-BB standard intervention

Treatment:

Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)

Experimental arm with enhanced intervention

Experimental group

Description:

Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.

Treatment:

Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)