Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

Not Applicable

Completed

• Conditions: Reproductive Health; Contraception; Sexually Transmitted Diseases

• Registration Number: NCT03765255
• Lead Sponsor: University of California, San Francisco

Brief Summary

This randomized control trial (RCT) will assess an innovative demonstration project to improve adolescent sexual and reproductive health among highly mobile and marginalized youth in Fresno County, California. The Digital Initiative for Youth intervention combines existing, in-person, group-based, comprehensive sexual health education with wraparound digital technologies. The technological component was designed by Youth+Tech+Health using a "youth-centered" design approach and the intervention is implemented by Fresno Economic Opportunities Commission (Fresno EOC). The University of California, San Francisco is the external evaluator. The RCT will assess health and behavioral outcomes at three time points (baseline, 4 months, 10 months).

Detailed Description

The Digital Initiative for Youth (DIY) is an innovative, youth-centered, digital intervention that aims to improve the health and well-being of adolescents ages 13-19 in Fresno County, California. In particular, it will address the needs of homeless and unstably housed youth, youth of color, sexual minority youth, and Native American youth using a trauma-informed approach and positive youth development framework.

DIY combines existing, in-person, group-based, comprehensive sexual health education with an app designed in consultation with youth. DIY is built on three strategies: positive youth development, youth-centered design, and wraparound technologies. It will focus on four main areas: sexual health and contraceptive use, healthy relationships, educational and career development, and life skills. The intervention includes six hours of in-person education and an app that includes a resource locator, goal setting, text message reminders, and additional information and referrals.

This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,

Fresno EOC is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the cohort (group) level. All control group participants will be invited to participate after completion of the long-term follow up period.

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1260

Inclusion Criteria

• Speak/understand Spanish or English
• Live within Fresno County, California at baseline (may move out afterward)
• Age between 13-19
• Have access to a smart phone or internet (does not need to own)

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Exclusion Criteria

• Do not live in Fresno County, California at baseline
• Do not speak or understand Spanish or English
• Severe mental health issues that prevent them from participating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported use of any clinic services in the last three months on survey	Long-term follow up (9 months)	Checked any services from survey list after question, "Please check all of the services you have received from a doctor, counselor, therapist, social worker, or clinic in the past 3 months." Respondents complete computer-based survey. Survey developed by UCSF.
Self-reported condom/contraceptive use or no sex in the last three months on survey	Short term follow up (3 months)	Answered some or all of the time to: In the past 3 months, how often did you or a partner use birth control when you had vaginal sex OR In the past 3 months, how often did you use condoms when you had anal sex? Respondents complete computer-based survey. Survey developed by University of California, San Francisco (UCSF).

Secondary Outcome Measures

Name	Time	Method
Self-reported sexual risk behavior on survey	Short-term follow up (3 months)	Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.
Self-reported knowledge of local clinical services on survey	Short-term follow up (3 months)	Answered yes to question on computer-based survey: "Have you heard of a clinic or doctor in your community where teens can get sexual health information and services such as condoms, birth control, pregnancy tests, sexually transmitted infection (STI) tests/treatment, and/or HIV tests?" Survey developed by UCSF.

Trial Locations

Locations (1)

Fresno Economic Opportunities Commission; 🇺🇸 Fresno, California, United States