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

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 Overview

• Status: Completed
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB); Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • APT Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm with standard intervention; Participants will complete a 4-week CHRP-BB standard intervention	Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB); 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.
Experimental: Experimental arm with enhanced intervention; Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.	Behavioral: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Connecticut
• Investigators: Principal Investigator: Michael B Copenhaver, PhD, University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: H22-0033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No