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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912374
Enrollment
50
Registered
2023-06-22
Start date
2022-09-07
Completion date
2022-12-12
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

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.

Interventions

BEHAVIORALstandard 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.

BEHAVIORALenhanced 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.

Sponsors

University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

single blind

Intervention model description

randomized controlled pilot trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HIV risk reduction skills assessment at baselinepre intervention (week 0)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 interventionpost intervention (week 4)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 prescriptionpost intervention (week 4)PrEP prescription filled by pharmacy

Secondary

MeasureTime frameDescription
number of participants recruitedpre intervention (week 0)Feasibility was measured via recruitment success
number of participants retained throughout studypost intervention (week 4)Feasibility was measured via retention success
Intervention Acceptabilitypost intervention (week 4)Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026