NCT03114410

Brief Summary

This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

March 16, 2017

Last Update Submit

April 30, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ever had sexual intercourse

    Single dichotomous item on self-report questionnaire.

    12 months after baseline

  • Unprotected sexual intercourse in the past 3 months.

    Single dichotomous item on self-report questionnaire.

    12 months after baseline

Secondary Outcomes (4)

  • Intentions

    3 and 12 months after baseline

  • Knowledge

    3 and 12 months after baseline

  • Attitudes

    3 and 12 months after baseline

  • Self-efficacy in avoiding unwanted/unprotected sex and communication with partners

    3 and 12 months after baseline

Study Arms (2)

Re:MIX

EXPERIMENTAL

In the experimental arm, the Re:MIX curriculum was implemented. The Re:MIX curriculum is a comprehensive teen pregnancy prevention consisting of ten hour-long sessions, delivered approximately once per week. The Re:MIX curriculum is taught by a professional health educator, partnered with a young parent educator who is a young parent (aged 18-25).

Behavioral: Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17

Comparison

NO INTERVENTION

In the comparison arm, teachers were given the option of implementing the Healthy Youth, Healthy You curriculum (focusing on nutrition, mental health, and fitness) or proceed with "business as usual" (no curriculum).

Interventions

Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).

Re:MIX

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students in 8-10th grade classrooms in three public charter schools in Travis County, Texas

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EngenderHealth

Austin, Texas, 78722, United States

Location

MeSH Terms

Conditions

Sexual BehaviorUnsafe Sex

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Manlove, PhD

    Child Trends, Senior Program Area Director

    PRINCIPAL INVESTIGATOR
  • Monica Armendariz

    EngenderHealth: Project Director/Co-Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Program Area Director

Study Record Dates

First Submitted

March 16, 2017

First Posted

April 14, 2017

Study Start

July 1, 2016

Primary Completion

December 17, 2019

Study Completion

April 30, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations