Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03112369|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention||Behavioral: Narrative Exposure Therapy (NET) Behavioral: Motivational Interviewing w/Skills Training (MIST)||Not Applicable|
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
- 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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use|
|Actual Study Start Date :||July 10, 2017|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Narrative Exposure Therapy (NET)
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)
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112369
|Contact: Rebeca A Marín, PhDfirstname.lastname@example.org|
|Contact: Lucy Smartlowit-Briggs, MSWemail@example.com|
|United States, Washington|
|University of Washington School of Social Work||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Rebeca A Marín, PhD 206-685-4927 firstname.lastname@example.org|
|Contact: Cynthia R Pearson, PhD 206-330-1997 email@example.com|
|Principal Investigator:||Cynthia R Pearson, PhD||University of Washington|
|Principal Investigator:||Debra Kaysen, PhD||University of Washington|