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Completed

NCT Number: NCT03765255

Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

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).

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Key information

Conditions

Reproductive Health Communicable Diseases Contraception Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fresno Economic Opportunities Commission

Fresno, California, 93701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

In the Know: sexual health education

Other

The in-person sessions include modules on: sexual and reproductive health (2 hours - anatomy, gender and sexual orientation, pregnancy, contraception, sexually transmitted infections); healthy relationships and life skills (2 hours - communication and negotiation, consent, violence, online dating, goal setting, strengths); and educational and career success (2 hours - educational and career options, applying for scholarships and financial aid, job readiness, resume preparation, interview skills). The app includes: online referrals, personal life plans/goal setting, text message reminders, quizzes, and other resources.

Primary outcomes

  1. Self-reported condom/contraceptive use or no sex in the last three months on survey

    Time frame: 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).

  2. Self-reported use of any clinic services in the last three months on survey

    Time frame: 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.

Secondary outcomes

  1. Self-reported sexual risk behavior on survey

    Time frame: Short-term follow up (3 months)

    Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.

  2. Self-reported knowledge of local clinical services on survey

    Time frame: 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.

Other outcomes

  1. Self-reported healthy relationship skills on survey

    Time frame: Short-term follow up (3 months)

    Increased number of correct answers on knowledge about healthy relationships questions on computer-based survey between baseline and short-term follow up. Survey developed by UCSF.

  2. Self-reported career and education skills on survey

    Time frame: Long-term follow up (9 months)

    Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.

  3. Self-reported goal setting skills on survey

    Time frame: Short-term follow up (3 months)

    Aggregate responses to "worked on an educational and/or career goal" and "made plans to reach your goals" on computer-based survey. Survey developed by UCSF.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Department of Health and Human Services
  • Fresno Economic Opportunities Commission
  • Youth+Tech+Health

Registry information

Official study title

Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth; An Innovative Youth-Centered Initiative to Improve the Sexual Health and Socio-Economic Well-Being of Youth in Fresno County, California

Acronym: PREIS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2018
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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