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

Cognitive Dysfunction Clinical Trial

Official title:

Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05912374
• Other study ID #: H22-0033
• Status: Completed
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: June 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction

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.
• 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.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	number of participants who picked up PrEP prescription	PrEP prescription filled by pharmacy	post intervention (week 4)
Secondary	number of participants recruited	Feasibility was measured via recruitment success	pre intervention (week 0)
Secondary	number of participants retained throughout study	Feasibility was measured via retention success	post intervention (week 4)
Secondary	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)