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

Not Applicable

Completed

• Conditions: Cognitive Dysfunction
• Interventions: Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB); Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)

• Registration Number: NCT05912374
• Lead Sponsor: University of Connecticut

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-07
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2023-06
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm with standard intervention	standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)	Participants will complete a 4-week CHRP-BB standard intervention
Experimental arm with enhanced intervention	enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)	Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.

Primary Outcome Measures

Name	Time	Method
HIV risk reduction skills assessment at baseline	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	post intervention (week 4)	PrEP prescription filled by pharmacy
HIV risk reduction skills assessment, post intervention	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 Outcome Measures

Name	Time	Method
number of participants retained throughout study	post intervention (week 4)	Feasibility was measured via retention success
Intervention Acceptability	post intervention (week 4)	Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention
number of participants recruited	pre intervention (week 0)	Feasibility was measured via recruitment success

Trial Locations

Locations (1)

APT Foundation; 🇺🇸 New Haven, Connecticut, United States