Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2017 by Cynthia Pearson, University of Washington

Sponsor
University of Washington

Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)

Information provided by (Responsible Party)
Cynthia Pearson, University of Washington

ClinicalTrials.gov Identifier
NCT03112369

First received: April 10, 2017
Last updated: September 15, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Prevention

Behavioral : Narrative Exposure Therapy (NET)
Behavioral : Motivational Interviewing w/Skills Training (MIST)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use

Further study details as provided by Cynthia Pearson, University of Washington:

Primary Outcome Measures

  • National Institute on Drug Abuse (NIDA) Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure [ Time Frame: 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 Drug Use as assessed by PhenX Toolkit [ Time Frame: 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.
  • Change in PTSD symptoms as assessed by the Posttraumatic Symptom Scale Interview Diagnostic and Statistical Manual 5th Ed (DSM-5) (PSSI5) [ Time Frame: 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.

Estimated Enrollment: 200
Study Start Date: July 10, 2017
Estimated Study Completion Date: June 30, 2021
Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Narrative Exposure Therapy (NET)
Counseling program
Behavioral: Narrative Exposure Therapy (NET)

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.

Experimental: Motivational Interviewing w/Skills Training (MIST)
Counseling program
Behavioral: Motivational Interviewing w/Skills Training (MIST)

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

Detailed Description:

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.
Counseling sessions Participants will be randomly assigned to either NET or MIST. To ensure the equivalence of groups and to reduce opportunities for selection bias we will stratify the randomization by gender (male vs. female) and age groups (<30 vs. >=30) and perform randomization in blocks with varying size (4/6/8). Participants will begin their six 90 to 120 minute sessions in within a week of completing the Baseline assessment. Each counseling session is audio recorded in order for investigators to test for fidelity and adherence to the culturally adapted therapy.

Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03112369

Contacts

Contact:   Rebeca A Marín, PhD 206-685-4927 rmarin@uw.edu
Contact:   Lucy Smartlowit-Briggs, MSW 206-543-7411 lsbriggs@uw.edu

Locations

United States, Washington
University of Washington School of Social Work Recruiting
Seattle, Washington, United States, 98105
Contact: Rebeca A Marín, PhD    206-685-4927    rmarin@uw.edu
Contact: Cynthia R Pearson, PhD    206-330-1997    pearsonc@uw.edu

Sponsors and Collaborators

University of Washington
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Cynthia R Pearson, PhD University of Washington
Principal Investigator: Debra Kaysen, PhD University of Washington
More Information

More Information


Responsible Party: Cynthia Pearson, Associate Professor, Director of Research, Indigenous Wellness Research Institute School of Social Work, University of Washington  
ClinicalTrials.gov Identifier: NCT03112369   History of Changes  
Other Study ID Numbers: STUDY00001359  
  R01MD011574  
Study First Received: April 10, 2017  
Last Updated: September 15, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Cynthia Pearson, University of Washington:

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

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.