Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 3/24/2019 |
| Start Date: | September 21, 2017 |
| End Date: | June 30, 2021 |
| Contact: | Rebeca A Marín, PhD |
| Email: | rmarin@uw.edu |
| Phone: | 206-685-4927 |
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.
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.
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.
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.
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
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