Recruiting

Observational Study

Sponsor:

Capacity Builders Inc.

Code:

NCT04180358

Conditions

Sexual Abstinence

Responsible Sex

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Accepted

Interventions

Native STAND

Regular Health/Physical Education Curriculum

Study Details

Brief 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.

Conditions

Sexual Abstinence

Responsible Sex

Study ID

NCT04180358

Start date

Oct 24, 2017

Status verified date

Nov, 2019

Completion date

Sep 29, 2021

Anticipated

Primary completion date

Feb 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

834 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Impact group

The impact group will receive the interventions in the classrooms

placebo comparator: Comparison group

Comparison group will not receive the intervention

Interventions

Native STAND

Native STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours.

Regular Health/Physical Education Curriculum

General health and physical education curriculum provided by New Mexico's Public Education Department.

Primary outcome measure

  • Abstaining from sexual activity [ Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months ]
  • Abstaining from sex or practicing safe sex [ Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months ]

Central Contacts and Locations

Central contacts

Kristen Rivas, MS Ed, LADC

775-690-5992orivasconsulting@charter.net

Locations

Capacity Builders Inc.

Recruiting

Farmington, New Mexico, United States, 87401

Contacts

Lois Ritter

505-326-4245l.ritter@capacitybuilders.info

Principal Investigator:

Lois Ritter

More Information

Sponsor

Capacity Builders Inc.

Last update posted

Nov 27, 2019

Last verified

Nov, 2019

Keywords

  • Navajo
  • Sex
  • Abstain
  • Culture
  • Random
  • Control
  • Trial
  • PREIS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Capacity Builders Inc. on 2019-11-27.