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Completed

NCT Number: NCT05912374

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APT Foundation

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)

Behavioral

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)

Behavioral

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 outcomes

  1. HIV risk reduction skills assessment at baseline

    Time frame: pre 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

  2. HIV risk reduction skills assessment, post intervention

    Time frame: post 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

  3. number of participants who picked up PrEP prescription

    Time frame: post intervention (week 4)

    PrEP prescription filled by pharmacy

Secondary outcomes

  1. number of participants recruited

    Time frame: pre intervention (week 0)

    Feasibility was measured via recruitment success

  2. number of participants retained throughout study

    Time frame: post intervention (week 4)

    Feasibility was measured via retention success

  3. Intervention Acceptability

    Time frame: post intervention (week 4)

    Participants completed an ten-item intervention acceptability rating, the lower the number the lower the participants acceptability of the intervention

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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