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

Primary Purpose

Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • APT Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm with standard intervention

Experimental arm with enhanced intervention

Arm Description

Participants will complete a 4-week CHRP-BB standard intervention

Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.

Outcomes

Primary Outcome Measures

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
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
number of participants who picked up PrEP prescription
PrEP prescription filled by pharmacy

Secondary Outcome Measures

number of participants recruited
Feasibility was measured via recruitment success
number of participants retained throughout study
Feasibility was measured via retention success
Intervention Acceptability
Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention

Full Information

First Posted
June 1, 2023
Last Updated
June 12, 2023
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT05912374
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled pilot trial
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm with standard intervention
Arm Type
Active Comparator
Arm Description
Participants will complete a 4-week CHRP-BB standard intervention
Arm Title
Experimental arm with enhanced intervention
Arm Type
Experimental
Arm Description
Participants will complete a 4-week CHRP-BB intervention enhanced with included cognitive dysfunction accommodation strategies.
Intervention Type
Behavioral
Intervention Name(s)
standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV risk reduction skills assessment at baseline
Description
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
Time Frame
pre intervention (week 0)
Title
HIV risk reduction skills assessment, post intervention
Description
a 15 item checklist of HIV risk reduction skills, the lower the score the lower the ability to perform HIV risk reduction skills
Time Frame
post intervention (week 4)
Title
number of participants who picked up PrEP prescription
Description
PrEP prescription filled by pharmacy
Time Frame
post intervention (week 4)
Secondary Outcome Measure Information:
Title
number of participants recruited
Description
Feasibility was measured via recruitment success
Time Frame
pre intervention (week 0)
Title
number of participants retained throughout study
Description
Feasibility was measured via retention success
Time Frame
post intervention (week 4)
Title
Intervention Acceptability
Description
Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention
Time Frame
post intervention (week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Copenhaver, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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