Clinical trial NCT03765255: Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Contraception
Sexually Transmitted Diseases
Keywords: youth
adolescent
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Youth+Tech+Health
name: Fresno Economic Opportunities Commission
name: Department of Health and Human Services
First posted: 2018-12-05
Enrollment: 1260
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents will be randomly assigned to treatment or control by cohort (groups of 5-25 adolescents). Adolescents will consent to participation and complete baseline survey prior to randomization. Enrollment will continue by cohort for approximately 2 years. Approximately 15 sites will participate with 2-4 cohorts per site per year.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported condom/contraceptive use or no sex in the last three months on survey
timeFrame: Short term follow up (3 months)
measure: Self-reported use of any clinic services in the last three months on survey
timeFrame: Long-term follow up (9 months)
Secondary outcomes:
measure: Self-reported sexual risk behavior on survey
timeFrame: Short-term follow up (3 months)
measure: Self-reported knowledge of local clinical services on survey
timeFrame: Short-term follow up (3 months)
Other outcomes:
measure: Self-reported healthy relationship skills on survey
timeFrame: Short-term follow up (3 months)
measure: Self-reported career and education skills on survey
timeFrame: Long-term follow up (9 months)
measure: Self-reported goal setting skills on survey
timeFrame: Short-term follow up (3 months)
Locations:
city: Fresno
country: United States
facility: Fresno Economic Opportunities Commission
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mara J Decker, DrPH
role: PRINCIPAL_INVESTIGATOR
References: