HIV Prevention Clinical Trial
Official title:
Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - 16 years old or older - Native American - At least sub-threshold PTSD - Substance use in the previous 12 months - Any lifetime sexual activity Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington School of Social Work | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | National Institute on Drug Abuse (NIDA) Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure | Measuring change in high risk sexual behavior for contracting HIV. | Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up | |
Primary | Change in Drug Use as assessed by PhenX Toolkit | This measure is used to assess changes in participant's substance use. | Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up | |
Primary | Change in PTSD symptoms as assessed by the Posttraumatic Symptom Scale Interview Diagnostic and Statistical Manual 5th Ed (DSM-5) (PSSI5) | This measure is used to assess the severity of the PTSD symptoms. | Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up |
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