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

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ClinicalTrials.gov Identifier: NCT03765255
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Youth+Tech+Health
Fresno Economic Opportunities Commission
Department of Health and Human Services
Information provided by (Responsible Party):
Mara Decker, University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Reproductive Health Contraception Sexually Transmitted Diseases Other: In the Know: sexual health education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1360 participants
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
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
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: In the Know: 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.
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.

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).



Primary Outcome Measures :
  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 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 Outcome Measures :
  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, STI tests/treatment, and/or HIV tests?" Survey developed by UCSF.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765255


Contacts
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Contact: Julio C Romero, MPH 559-265-5504 Julio.Romero@fresnoeoc.org
Contact: Abigail Gutmann-Gonzalez, MPH 415-476-9507 abigail.gutmann-gonzalez@ucsf.edu

Locations
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United States, California
Fresno Economic Opportunities Commission Recruiting
Fresno, California, United States, 93701
Contact: Julio C Romero, MPH         
Sponsors and Collaborators
University of California, San Francisco
Youth+Tech+Health
Fresno Economic Opportunities Commission
Department of Health and Human Services
Investigators
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Principal Investigator: Mara J Decker, DrPH University of California, San Francisco

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Responsible Party: Mara Decker, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03765255     History of Changes
Other Study ID Numbers: 90AP2688
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (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
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.

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

Keywords provided by Mara Decker, University of California, San Francisco:
youth
adolescent

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female