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

Study Overview
=================
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.

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

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)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled pilot trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm with standard intervention<br>Participants will complete a 4-week CHRP-BB standard intervention | Behavioral: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)<br>* 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.<br>|
| Experimental: Experimental arm with enhanced intervention<br>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)<br>* 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.<br>|

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) |