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

Primary Purpose

Reproductive Health, Contraception, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In the Know: sexual health education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reproductive Health focused on measuring youth, adolescent

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fresno Economic Opportunities Commission

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

In the Know (ITK): sexual health education

Control: do not receive ITK intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 13, 2018
Last Updated
July 27, 2021
Sponsor
University of California, San Francisco
Collaborators
Youth+Tech+Health, Fresno Economic Opportunities Commission, Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT03765255
Brief Title
Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Youth+Tech+Health, Fresno Economic Opportunities Commission, Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reproductive Health, Contraception, Sexually Transmitted Diseases
Keywords
youth, adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
1260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In the Know (ITK): sexual health education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: do not receive ITK intervention
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
In the Know: sexual health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported condom/contraceptive use or no sex in the last three months on survey
Description
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).
Time Frame
Short term follow up (3 months)
Title
Self-reported use of any clinic services in the last three months on survey
Description
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.
Time Frame
Long-term follow up (9 months)
Secondary Outcome Measure Information:
Title
Self-reported sexual risk behavior on survey
Description
Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.
Time Frame
Short-term follow up (3 months)
Title
Self-reported knowledge of local clinical services on survey
Description
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.
Time Frame
Short-term follow up (3 months)
Other Pre-specified Outcome Measures:
Title
Self-reported healthy relationship skills on survey
Description
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.
Time Frame
Short-term follow up (3 months)
Title
Self-reported career and education skills on survey
Description
Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.
Time Frame
Long-term follow up (9 months)
Title
Self-reported goal setting skills on survey
Description
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.
Time Frame
Short-term follow up (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara J Decker, DrPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresno Economic Opportunities Commission
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are in discussion with our federal sponsor to determine the sharing plan for a public use dataset.
IPD Sharing Time Frame
Data will be available on or before October 2021.
IPD Sharing Access Criteria
Requirements for access is being developed by the federal sponsors.

Learn more about this trial

Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

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