CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 538 enrolled
Drug / intervention
School-based curriculumbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05037656
NCT05037656N/ACompleted

University of Guam/University of Hawaii Cancer Center Partnership for Cancer Health Equity, Full Project I: Developing and Testing a School-Based Curriculum for E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention for Guam Youths

University of Guam·interventional·Posted Sep 8, 2021·Updated May 5, 2026

In Brief

A clinical study evaluating School-based curriculum for Tobacco Smoking and 2 related conditions. Completed, enrolled 538 participants across 1 site.

Detailed Summary

The people of the U.S. Affiliated Pacific Islands (USAPI) face higher cancer incidence, especially lung/bronchia and head-and-neck cancer, and poorer cancer outcomes, compared with the U.S. nationally. This may partly be driven by the high rates of cigarette smoking and betel (areca) nut use in the USAPI. Previous data suggest that that adolescents on Guam, as young as middle school students report markedly higher e-cigarette and tobacco product use prevalence in the USAPI compared with the USAPI nationally. Guam youths are also at risk for the use of betel nuts. Yet, currently there are no tobacco product/areca nut use prevention programs that have been developed for and tested specifically USAPI adolescents. The proposed study will develop a school-based substance use prevention curriculum for e-cigarette, tobacco product, and areca nut use prevention among Guam youths. The curriculum will use lessons incorporating innovative videos and culturally grounded activities. The study's specific aims are: 1. To develop a school-based curriculum for e-cigarette, tobacco product (i.e., cigarette, smokeless tobacco), and betel nut use prevention among middle school students in Guam. 2. Test the efficacy of the school-based curriculum in a randomized controlled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGuam

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 8, 2021
Enrollment StartSep 14, 2022
Primary CompletionAug 31, 2024
Study CompletionAug 31, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.8 years ago

Interventions

School-based curriculumbehavioral

Participants will be randomized, at the school level, to receive either the e-cigarette/tobacco/areca nut use prevention curriculum or the standard of care (i.e., control). The curriculum will be implemented using 5 intensive in-class lessons over the span of 6 weeks. All sessions of the curriculum follow the same basic format: a) an introduction and/or review of the past lesson, b) a cultural wall activity, c) a video, d) 1-2 interactive activities, and e) a wrap-up activity. Lessons are designed such as to help improve knowledge about drugs and correct cognitive misperceptions and to train on skills to resist normative social influence. Participants will complete identical survey questionnaires for assessments at 3 time-points: pretest (baseline, before implementing the intervention), immediate posttest (following the end of the intervention), and six-month follow-up. The surveys will be administered in the classroom, during regular school hours.