HIV PreventionNCT03112369
Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
A study testing Narrative Exposure Therapy (NET) and Motivational Interviewing w/Skills Training (MIST) in people with HIV Prevention and PTSD and Substance Use Disorder, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, PTSD and Substance Use Disorder
- What is being tested?
- Narrative Exposure Therapy (NET) and Motivational Interviewing w/Skills Training (MIST)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 16 years old or older
- Native American
- At least sub-threshold PTSD
- Substance use in the previous 12 months
- Any lifetime sexual activity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Social Work
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- HIV Prevention, PTSD and Substance Use Disorder
- Being tested
- Narrative Exposure Therapy (NET), Motivational Interviewing w/Skills Training (MIST)
- Keywords
- American Indian / Alaska Native, HIV Prevention, Sexual Risk Behavior, Trauma, Substance Use
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure Therapy (NET)Behavioural
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.
Motivational Interviewing w/Skills Training (MIST)Behavioural
Motivational interviewing (MI) coupled with skills training is based on enhancing motivation to change and building skills to address substance use behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy (NET) | Experimental | Counseling program Receives: Behavioral: Narrative Exposure Therapy (NET) |
| Motivational Interviewing w/Skills Training (MIST) | Experimental | Counseling program Receives: Behavioral: Motivational Interviewing w/Skills Training (MIST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This measure is used to assess changes in participant's substance use.
Measured: 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)
This measure is used to assess the severity of the PTSD symptoms.
Measured: Baseline and Post Intervention; Baseline and 3-month Follow up; Baseline and 6-month Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start21 Sep 2017
- Primary completion16 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Cynthia Pearson, University of Washington
- Investigators
- Cynthia R Pearson, PhD, Principal investigator, University of WashingtonDebra Kaysen, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112369
- Sponsor's protocol ID
- STUDY00001359
- Other IDs
- R01MD011574
- Status last verified
- Sep 2024
- First submitted
- 10 Apr 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only De-identified IPD will be available after institutional IRB and tribal approval
Publications
Walker D, Pearson C, Day A, Bedard-Gilligan M, Saluskin K, Huh D, Kaysen D. A Community Engaged Approach in Adapting Motivational Interviewing and Skills Training for Native Americans With Experiences of Substance Misuse. Am J Health Promot. 2023 Jul;37(6):796-806. doi: 10.1177/08901171231161467. Epub 2023 Mar 4.
PubMed 36869715Bedard-Gilligan M, Kaysen D, Cordero RM, Huh D, Walker D, Kaiser-Schauer E, Robjant K, Saluskin K, Pearson C. Adapting narrative exposure therapy with a tribal community: A community-based approach. J Clin Psychol. 2022 Nov;78(11):2087-2108. doi: 10.1002/jclp.23395. Epub 2022 May 27.
PubMed 35621371Pearson 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.
PubMed 32561467
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
- ClinicalTrials.gov ID
- NCT03112369
- Acronym / sponsor ID
- STUDY00001359
- Conditions
- HIV Prevention, PTSD and Substance Use Disorder
- Keywords
- American Indian / Alaska Native, HIV Prevention, Sexual Risk Behavior, Trauma, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy (NET) | Experimental | Behavioral: Narrative Exposure Therapy (NET)Counseling program |
| Motivational Interviewing w/Skills Training (MIST) | Experimental | Behavioral: Motivational Interviewing w/Skills Training (MIST)Counseling program |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16 years old or older
- Native American
- At least sub-threshold PTSD
- Substance use in the previous 12 months
- Any lifetime sexual activity
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Narrative Exposure Therapy (NET) |
| 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. | Behavioural | Motivational Interviewing w/Skills Training (MIST) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36869715Walker D, Pearson C, Day A, Bedard-Gilligan M, Saluskin K, Huh D, Kaysen D. A Community Engaged Approach in Adapting Motivational Interviewing and Skills Training for Native Americans With Experiences of Substance Misuse. Am J Health Promot. 2023 Jul;37(6):796-806. doi: 10.1177/08901171231161467. Epub 2023 Mar 4.
- Background: PubMed 35621371Bedard-Gilligan M, Kaysen D, Cordero RM, Huh D, Walker D, Kaiser-Schauer E, Robjant K, Saluskin K, Pearson C. Adapting narrative exposure therapy with a tribal community: A community-based approach. J Clin Psychol. 2022 Nov;78(11):2087-2108. doi: 10.1002/jclp.23395. Epub 2022 May 27.
- Background: PubMed 32561467Pearson 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.
- Individual participant dataSharing planned: Yes. Only De-identified IPD will be available after institutional IRB and tribal approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia R Pearson, PhD principal investigator
University of Washington
Debra Kaysen, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy (NET) and Motivational Interviewing w/Skills Training (MIST) in people with HIV Prevention and PTSD and Substance Use Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.