Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

Contraception Clinical Trial

— PREIS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765255
• Other study ID #: 90AP2688
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1260
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Reproductive Health
• Sexually Transmitted Diseases

Intervention

Other:
• In the Know: sexual health education
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.

Locations

Country	Name	City	State
United States	Fresno Economic Opportunities Commission	Fresno	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Department of Health and Human Services, Fresno Economic Opportunities Commission, Youth+Tech+Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported healthy relationship skills on survey	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.	Short-term follow up (3 months)
Other	Self-reported career and education skills on survey	Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.	Long-term follow up (9 months)
Other	Self-reported goal setting skills on survey	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.	Short-term follow up (3 months)
Primary	Self-reported condom/contraceptive use or no sex in the last three months on survey	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).	Short term follow up (3 months)
Primary	Self-reported use of any clinic services in the last three months on survey	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.	Long-term follow up (9 months)
Secondary	Self-reported sexual risk behavior on survey	Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.	Short-term follow up (3 months)
Secondary	Self-reported knowledge of local clinical services on survey	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.	Short-term follow up (3 months)