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

April 5, 2023 updated by: Cynthia Pearson, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rebeca A Marín, PhD
  • Phone Number: 206-685-4927
  • Email: rmarin@uw.edu

Study Contact Backup

  • Name: Lucy Smartlowit-Briggs, MSW
  • Phone Number: 206-543-7411
  • Email: lsbriggs@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington School of Social Work
        • Contact:
        • Contact:
          • Rebeca A Marín, PhD
          • Phone Number: 206-685-4927
          • Email: rmarin@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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)
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.
Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Anticipated)

March 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001359
  • R01MD011574 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only De-identified IPD will be available after institutional IRB and tribal approval

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Prevention

Clinical Trials on Narrative Exposure Therapy (NET)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe