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

Primary Purpose

HIV Prevention

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Exposure Therapy (NET)
Motivational Interviewing w/Skills Training (MIST)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Prevention focused on measuring American Indian / Alaska Native, HIV Prevention, Sexual Risk Behavior, Trauma, Substance Use

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington School of Social WorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Narrative Exposure Therapy (NET)

Motivational Interviewing w/Skills Training (MIST)

Arm Description

Counseling program

Counseling program

Outcomes

Primary Outcome Measures

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.
Change in Drug Use as assessed by PhenX Toolkit
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)
This measure is used to assess the severity of the PTSD symptoms.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2017
Last Updated
April 5, 2023
Sponsor
University of Washington
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03112369
Brief Title
Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
Official Title
Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention
Keywords
American Indian / Alaska Native, HIV Prevention, Sexual Risk Behavior, Trauma, Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy (NET)
Arm Type
Experimental
Arm Description
Counseling program
Arm Title
Motivational Interviewing w/Skills Training (MIST)
Arm Type
Experimental
Arm Description
Counseling program
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy (NET)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing w/Skills Training (MIST)
Intervention Description
Motivational interviewing (MI) coupled with skills training is based on enhancing motivation to change and building skills to address substance use behaviors.
Primary Outcome Measure Information:
Title
National Institute on Drug Abuse (NIDA) Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure
Description
Measuring change in high risk sexual behavior for contracting HIV.
Time Frame
Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up
Title
Change in Drug Use as assessed by PhenX Toolkit
Description
This measure is used to assess changes in participant's substance use.
Time Frame
Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up
Title
Change in PTSD symptoms as assessed by the Posttraumatic Symptom Scale Interview Diagnostic and Statistical Manual 5th Ed (DSM-5) (PSSI5)
Description
This measure is used to assess the severity of the PTSD symptoms.
Time Frame
Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebeca A Marín, PhD
Phone
206-685-4927
Email
rmarin@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Smartlowit-Briggs, MSW
Phone
206-543-7411
Email
lsbriggs@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia R Pearson, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debra Kaysen, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Social Work
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebeca A Marín, PhD
Phone
206-685-4927
Email
rmarin@uw.edu
First Name & Middle Initial & Last Name & Degree
Cynthia R Pearson, PhD
Phone
206-330-1997
Email
pearsonc@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only De-identified IPD will be available after institutional IRB and tribal approval
Citations:
PubMed Identifier
32561467
Citation
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.
Results Reference
derived

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

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