Clinical trial NCT05912374: Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
Official title: Implementing Cognitive Dysfunction Accommodation Strategies Into a Biobehavioral Pre-Exposure Prophylaxis (PrEP) Focused HIV Prevention Intervention for People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled pilot trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: HIV risk reduction skills assessment at baseline
timeFrame: pre intervention (week 0)
measure: HIV risk reduction skills assessment, post intervention
timeFrame: post intervention (week 4)
measure: number of participants who picked up PrEP prescription
timeFrame: post intervention (week 4)
Secondary outcomes:
measure: number of participants recruited
timeFrame: pre intervention (week 0)
measure: number of participants retained throughout study
timeFrame: post intervention (week 4)
measure: Intervention Acceptability
timeFrame: post intervention (week 4)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael B Copenhaver, PhD
role: PRINCIPAL_INVESTIGATOR
References: