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

NCT03112369 | Completed DMC

• 2 other identifiers: STUDY00001359R01MD011574
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention; PTSD and Substance Use Disorder

Keywords

American Indian / Alaska Native; HIV Prevention; Sexual Risk Behavior; Trauma; Substance Use

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Narrative Exposure Therapy (NET)

EXPERIMENTAL

Counseling program

Behavioral: Narrative Exposure Therapy (NET)

Motivational Interviewing w/Skills Training (MIST)

EXPERIMENTAL

Counseling program

Behavioral: Motivational Interviewing w/Skills Training (MIST)

Interventions

Narrative Exposure Therapy (NET) BEHAVIORAL

An international evidence-based program (EBP) for PTSD based on exposure therapy, an oral tradition of story-telling, and use of tactile medium of natural elements.

Narrative Exposure Therapy (NET)

Motivational Interviewing w/Skills Training (MIST) BEHAVIORAL

Motivational interviewing (MI) coupled with skills training is based on enhancing motivation to change and building skills to address substance use behaviors.

Motivational Interviewing w/Skills Training (MIST)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Washington School of Social Work

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• Walker D, Pearson C, Day A, Bedard-Gilligan M, Saluskin K, Huh D, Kaysen D. A Community Engaged Approach in Adapting Motivational Interviewing and Skills Training for Native Americans With Experiences of Substance Misuse. Am J Health Promot. 2023 Jul;37(6):796-806. doi: 10.1177/08901171231161467. Epub 2023 Mar 4.

  PMID: 36869715 BACKGROUND

• Bedard-Gilligan M, Kaysen D, Cordero RM, Huh D, Walker D, Kaiser-Schauer E, Robjant K, Saluskin K, Pearson C. Adapting narrative exposure therapy with a tribal community: A community-based approach. J Clin Psychol. 2022 Nov;78(11):2087-2108. doi: 10.1002/jclp.23395. Epub 2022 May 27.

  PMID: 35621371 BACKGROUND

• Pearson CR, Kaysen D, Huh D, Bedard-Gillgan M, Walker D, Marin R, Saluskin K. A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol. Contemp Clin Trials. 2020 Aug;95:106070. doi: 10.1016/j.cct.2020.106070. Epub 2020 Jun 17.

  PMID: 32561467 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Cynthia R Pearson, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Debra Kaysen, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Research, Indigenous Wellness Research Institute School of Social Work

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: September 21, 2017
• Primary Completion: August 16, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)