Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth (PREIS)

• ClinicalTrials.gov Identifier: NCT03765255
• Recruitment Status: Active, not recruiting
• First Posted: December 5, 2018
• Last Update Posted: February 15, 2021
• Sponsor: University of California, San Francisco
• Collaborators: Youth+Tech+Health; Fresno Economic Opportunities Commission; Department of Health and Human Services
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: November 13, 2018
• First Posted Date: December 5, 2018
• Last Update Posted Date: February 15, 2021
• Actual Study Start Date: October 17, 2017
• Estimated Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2021)

• 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).
• 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.

Original Primary Outcome Measures (submitted: December 3, 2018)

• 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 UCSF.
• 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.

Current Secondary Outcome Measures (submitted: December 3, 2018)

• 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.
• 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, STI tests/treatment, and/or HIV tests?" Survey developed by UCSF.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 3, 2018)

• 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.
• 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.
• 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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Masking Description:

The adolescents and the staff enrolling the participants will not know of study assignment until after completing recruitment, consent, and baseline. At that point, they will open an envelope stating if it is a control or treatment cohort. The researcher conducting the outcomes analysis will not know enrollment status of an individual.

Primary Purpose: Prevention

Condition

• Reproductive Health
• Contraception
• 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.

Study Arms

• Experimental: In the Know (ITK): sexual health education
  Cohorts/participants in the experimental (treatment) arm receive an intervention that combines 6 hours of in-person sexual health and adolescent development education with an app that includes a resource locator, text message reminders (for one month), goal setting, and other resources.
  Intervention: Other: In the Know: sexual health education
• No Intervention: Control: do not receive ITK intervention
  Cohorts/participants in the no intervention arm do not receive either the in-person education or the app. However, after completing the 10 month survey, they will have access to the app and will be invited to participate in the in-person program after the study implementation phase is completed (years 4 and 5).

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 10, 2021): 1260
• Original Estimated Enrollment (submitted: December 3, 2018): 1360
• Estimated Study Completion Date: September 30, 2021
• Estimated Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03765255
• Other Study ID Numbers: 90AP2688
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: We are in discussion with our federal sponsor to determine the sharing plan for a public use dataset.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data will be available on or before October 2021.
• Access Criteria: Requirements for access is being developed by the federal sponsors.

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

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

Investigators

• Principal Investigator: Mara J Decker, DrPH; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: February 2021