Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strateg… (NCT04180358) | Clinical Trial Compass
UnknownNot Applicable
Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project
United States834 participantsStarted 2017-10-24
Plain-language summary
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native Students Together Against Negative Decisions (Native STAND) which aims to reduce pregnancies, births, and sexually transmitted infections (STI's) including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. The study has two hypotheses: (1) Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months as compared to students assigned to the comparison group, measured at 12 month and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up); (2) Do students assigned to the Youth Builders program have a greater change of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group, measured at 12 and 18 months after random assignment? (No sexual activity or use contraception if engage in sex at 12 month and 18 month follow up.
Who can participate
Age range
14 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between the ages of 14-18
* In grades 9-11
* Provide parental consent and participant assent to participate in the study
* Students in the first two groups will be allowed to participate in the intervention if they are enrolled in the classroom that will be receiving the intervention
* Students in the third group will be allowed to participate in the intervention only if they were part of the study's intervention group
Exclusion Criteria:
* Not have previously participated in any of the following past CBI Teen Pregnancy
Prevention programs:
* New Mexico's Department of Health - Wyman's Teen Outreach Program
* Success with Adolescent Goals, inclusive of the Above the Waist Curriculum
* Students in 12th grade
* Study participants from previous cohorts
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abstaining from sexual activity
Timeframe: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
2
Abstaining from sex or practicing safe sex
Timeframe: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months