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临床试验/NCT05912374
NCT05912374已完成不适用

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

University of Connecticut1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
HIV risk reduction skills assessment at baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

single blind

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •cannot attend all study sessions
  • •actively homicidal and/or suicidal

研究组 & 干预措施

Control arm with standard intervention

Active Comparator

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

干预措施: standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) (Behavioral)

Experimental arm with enhanced intervention

Experimental

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

干预措施: enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB) (Behavioral)

结局指标

主要结局

HIV risk reduction skills assessment at baseline

时间窗: 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

number of participants who picked up PrEP prescription

时间窗: post intervention (week 4)

PrEP prescription filled by pharmacy

HIV risk reduction skills assessment, post intervention

时间窗: 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

次要结局

  • number of participants retained throughout study(post intervention (week 4))
  • Intervention Acceptability(post intervention (week 4))
  • number of participants recruited(pre intervention (week 0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Copenhaver

Professor

University of Connecticut

研究点 (1)

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