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临床试验/NCT03112369
NCT03112369进行中(未招募)不适用

Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use

University of Washington2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
125
试验地点
2
主要终点
Change in Drug Use as assessed by PhenX Toolkit

研究概览

简要总结

Investigators will conduct a two-arm, comparative effectiveness randomized controlled trial of two culturally adapted, empirically based programs (EBP) - Narrative Exposure Therapy (NET) vs. Motivational Interviewing with Skills Training (MIST) in terms of lowering HIV sexual-risk behaviors (HSB) for American Indian / Alaska Native (AIAN) men and women. NET addresses Posttraumatic Stress Disorder (PTSD) as a pathway to preventing substance use disorders (SUD) and HSB whereas MIST addresses substance misuse as a way of preventing SUD and HSB.

详细描述

Recruitment Participants will be recruited from tribal health and wellness service agencies and counseling centers on the Reservation as well as through advertising in the community. Investigators will post flyers in public spaces like coffee shops, the library, the cultural center, and community centers. We will also send the flyer through the tribal listserv; post it on Facebook, and the local newspaper. Investigators will provide brief oral presentations at the local health centers to orient providers of the project and provide contact information and flyers. Providers and potential participants who are interested may contact the study coordinator for more information

Screening

  • Participants are screened in person or over the phone using a screening script.
  • Participants who screen out will be given a community resource list either by mail, email, or in person.
  • If a person is eligible but declines to participate, they will be given a one item exit question regarding general reason for non-participation.

Consent and Baseline Assessment After completing the screener, the participant will be scheduled for an in-person consenting / baseline assessment appointment. Study staff will review the consent form with the participant. Once participant has consented, study staff will gather all relevant contact information. Next, study staff will set up the computer for the participant to complete the Audio Computer Assisted Self-interview (ACASI) survey, which will take approximately 30 minutes. While the participant is completing the survey, local study staff will call the Research Coordinator (RC) to confirm the consent has been obtained and to determine randomization. The RC will let the local study staff know which counselor the person should be scheduled with for the 1st counseling appointment. The counselor will inform which therapy the participant was assigned to at their first counseling session. Once participant completes the computer survey, study staff will schedule their first counseling appointment to take place within a week of the baseline appointment.

Assessments The assessments will be conducted via Audio-Computer Assisted Self-Interviews (ACASI) programmed into study computers. Participants will complete 4 surveys: baseline, immediately after completing counseling, a three-month follow up and a six-month follow up.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 16 years old or older
  • Native American
  • At least sub-threshold PTSD
  • Substance use in the previous 12 months
  • Any lifetime sexual activity

排除标准

  • Suicidal ideation, plan, or attempt in the previous 30 days
  • Homicidal ideation in the previous 3 months
  • Psychiatric medication that has not been stable for at least 2 months
  • A DSM-5 alcohol dependence diagnosis with severe withdrawal symptoms

结局指标

主要结局

Change in Drug Use as assessed by PhenX Toolkit

时间窗: Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up

This measure is used to assess changes in participant's substance use.

National Institute on Drug Abuse (NIDA) Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure

时间窗: Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up

Measuring change in high risk sexual behavior for contracting HIV.

Change in PTSD symptoms as assessed by the Posttraumatic Symptom Scale Interview Diagnostic and Statistical Manual 5th Ed (DSM-5) (PSSI5)

时间窗: Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up

This measure is used to assess the severity of the PTSD symptoms.

次要结局

未报告次要终点

研究者

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

Cynthia Pearson

Associate Professor, Director of Research, Indigenous Wellness Research Institute School of Social Work

University of Washington

研究点 (2)

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