Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

NCT03765255 | Completed

• 1 other identifier: 90AP2688
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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).

Conditions

Reproductive Health; Contraception; Sexually Transmitted Diseases

Keywords

youth; adolescent

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Self-reported sexual risk behavior on survey

  Short-term follow up (3 months)

• Self-reported knowledge of local clinical services on survey

  Short-term follow up (3 months)

Other Outcomes (3)

• Self-reported healthy relationship skills on survey

  Short-term follow up (3 months)

• Self-reported career and education skills on survey

  Long-term follow up (9 months)

• Self-reported goal setting skills on survey

  Short-term follow up (3 months)

Study Arms (2)

In the Know (ITK): sexual health education

EXPERIMENTAL

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.

Other: In the Know: sexual health education

Control: do not receive ITK intervention

NO 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).

Interventions

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.

In the Know (ITK): sexual health education

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Youth+Tech+Health: collaborator
• Fresno Economic Opportunities Commission: collaborator
• Department of Health and Human Services: collaborator

Study Sites (1)

Fresno Economic Opportunities Commission

Fresno, California, 93701, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mara J Decker, DrPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 5, 2018
• Study Start: October 17, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available on or before October 2021.
• Access Criteria: Requirements for access is being developed by the federal sponsors.

Locations

US (1)