Substance UseNCT06559774
The Hastiin Bidziil (Strong Man) Intervention
A study testing Hastiin Bidziil in people with Substance Use, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial summary
The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use
- What is being tested?
- Hastiin Bidziil
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as American Indian
- Self-identify as a man
- Age 18 years or older at time of enrollment
- Screen positive for lifetime use of alcohol and/or drugs, except for tobacco use only
- Reside within ~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)
Who cannot join
- Any condition that would affect successful participation (e.g., planned move)
- Profound disability that limits the ability to participate in assessments or interventions
- Participated in the preliminary phase of this study to adapt CETA for this project
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Navajo Nation Center for Indigenous Health - Chinle
Chinle, Arizona, 86503
Kyann Dedman-Cisco, MPH, 928-674-6824
- Recruiting
Navajo Nation Center for Indigenous Health - Fort Defiance
Fort Defiance, Arizona, 86504
Kyann Dedman-Cisco, MPH, 928-729-2435
About this study
Official title: The Hastiin Bidziil (Strong Man) Intervention: A Study to Measure the Effectiveness of a Secondary Prevention Program Aimed at Reducing Substance Use Among Adult Native Men
The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18 years and older
- Conditions
- Substance Use
- Being tested
- Hastiin Bidziil, Control condition - vehicle maintenance
- Keywords
- Young Men, Common Elements Treatment Approach (CETA)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hastiin BidziilBehavioural
Common Elements Treatment Approach (CETA) modified for cultural and gendered specific delivery for maximum community impact
Control condition - vehicle maintenanceOther
Control condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance such as changing tire, checking fluid levels, and winterizing vehicles.
| Study group | Role | What they receive |
|---|---|---|
| Hastiin Bidziil (Strong Man) intervention | Experimental | CETA intervention adapted for AI men ages 18 and older. Adaptation will take place leading up to implementation of the randomized controlled trial Receives: Behavioral: Hastiin Bidziil |
| Active Control Group - Vehicle Maintenance | Placebo comparator | Control condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance. Receives: Other: Control condition - vehicle maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of substance sse as assessed by Time Line Follow-back
Number of days of substance use over the previous month measured at 8-months post baseline using Timeline Follow-Back (TLFB)
Measured: 8-months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start18 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Richards, PhD, Principal investigator, Johns Hopkins UniversityJerreed D Ivanich, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559774
- Sponsor's protocol ID
- IRB00027710
- Status last verified
- May 2026
- First submitted
- 15 Aug 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hastiin Bidziil (Strong Man) Intervention: A Study to Measure the Effectiveness of a Secondary Prevention Program Aimed at Reducing Substance Use Among Adult Native Men
- ClinicalTrials.gov ID
- NCT06559774
- Acronym / sponsor ID
- IRB00027710
- Conditions
- Substance Use
- Keywords
- Young Men, Common Elements Treatment Approach (CETA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Aug 2024 (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.
The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18 years and older
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hastiin Bidziil (Strong Man) intervention | Experimental | Behavioral: Hastiin BidziilCETA intervention adapted for AI men ages 18 and older. Adaptation will take place leading up to implementation of the randomized controlled trial |
| Active Control Group - Vehicle Maintenance | Placebo comparator | Other: Control condition - vehicle maintenanceControl condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identify as American Indian
- Self-identify as a man
- Age 18 years or older at time of enrollment
- Screen positive for lifetime use of alcohol and/or drugs, except for tobacco use only
- Reside within ~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)
Key exclusion criteria (3 listed)
- Any condition that would affect successful participation (e.g., planned move)
- Profound disability that limits the ability to participate in assessments or interventions
- Participated in the preliminary phase of this study to adapt CETA for this project
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 |
|---|---|---|
| Hastiin BidziilCommon Elements Treatment Approach (CETA) modified for cultural and gendered specific delivery for maximum community impact | Behavioural | Hastiin Bidziil (Strong Man) intervention |
| Control condition - vehicle maintenanceControl condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance such as changing tire, checking fluid levels, and winterizing vehicles. | Other | Active Control Group - Vehicle Maintenance |
Primary outcome
Number of days of substance sse as assessed by Time Line Follow-back
Time frame: 8-months post baseline
Number of days of substance use over the previous month measured at 8-months post baseline using Timeline Follow-Back (TLFB)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Richards, PhD principal investigator
Johns Hopkins University
Jerreed D Ivanich, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hastiin Bidziil in people with Substance Use, run by Johns Hopkins Bloomberg School of Public Health at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyann Dedman-Cisco, MPH (928-674-6824, kdedman1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of substance sse as assessed by Time Line Follow-back (time frame: 8-months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026; AzTrials last refreshed its copy on 5 Nov 2026.