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NCT06929520
The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth
NA trial testing ENDS Prevention Intervention (TBD) in E-cigarette Use in 500 participants. Not yet recruiting.
15 May 2027
Quick facts
| Lead sponsor | University of Hawaii |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 500 |
| Start date | 15 October 2025 |
| Primary completion | 15 May 2027 |
| Estimated completion | 15 May 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ENDS Prevention Intervention (TBD)
Conditions studied
- E-cigarette Use — all drugs for E-cigarette Use →
- Substance Use — all drugs for Substance Use →
Sponsor
University of Hawaii
Who can join
Adults 10 to 14, any sex, with E-cigarette Use or Substance Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle/intermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and/or difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography/production stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social/print media campaign) across all middle/intermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06929520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Hawaii trials
Trials by the same sponsor.
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- NCT07075575 — Quit-Smoking Study for Native Hawaiians · NA · not yet recruiting
- NCT07075120 — Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer · Phase 1 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06929520 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Hawaii
- Last refreshed: 16 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06929520.
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