Evaluation of the SafeSpace App Intervention
SafeSpace
1 other identifier
interventional
1,000
1 country
1
Brief Summary
The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health. The investigators will ask participants to:
- Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks.
- Provide contact information.
- Receive and open app push notifications for 10 weeks (up to 3 per week).
- Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up).
- Receive occasional text messages from the study team.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2023
CompletedFirst Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2026
ExpectedNovember 21, 2023
November 1, 2023
2.7 years
September 12, 2023
November 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Penile-vaginal sex without a condom or a more effective method of contraception
Yes = Had penile-vaginal sex without using pill, shot, patch, ring, IUD, implant, or condom every time; No = Did not have penile-vaginal sex OR always used pill, shot, patch, ring, IUD, implant, or condom during penile-vaginal sex
Past 3 months at baseline; past 9 months at long-term follow-up
Secondary Outcomes (4)
Penile-vaginal sex or anal sex without a condom every time
Past 3 months at baseline; past 9 months at long-term follow-up
Utilization of sexual health services
Has received SRH services in the past 12 months or has an appointment scheduled in the next 3 months at baseline; Received SRH services in the past 9 months or has an appointment scheduled in the next 3 months at long-term follow-up.
Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.
Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Sexual agency during every recent sexual experience or no recent sexual experiences
Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Study Arms (2)
SafeSpace Sexual Health
EXPERIMENTALThe proposed intervention is a 10-week app-based program, SafeSpace Sexual Health. SafeSpace Sexual Health will be implemented using a secure, anonymous mobile app that uses authentic stories to engage young people with sexual health information and resources. The program addresses healthy relationships, anatomy and physiology, identity, adolescent development, STIs/HIV, pregnancy and reproduction, decision-making, personal safety, communication, and accessing healthcare. Each lesson includes a story written by youth with lived experience, two to three key facts developed by sexual health experts, a reflection prompt, and two to three reputable resources.
SafeSpace General Health
ACTIVE COMPARATORParticipants in the control condition will participate in a 10-week app-based general health program, SafeSpace General Health. Lessons address general health topics including self-care, stress, sleep, nutrition, physical activity, substance use, driving and seatbelt use, and social media. Each lesson contains 2-3 key facts created by public health experts and reputable resources. Similar to SafeSpace Sexual Health, youth will receive SafeSpace General Health over 10 weeks, although SafeSpace General Health includes one lesson per week and does not contain youth stories or reflection prompts.
Interventions
The overall goal of the program is to prevent adolescent pregnancy and STIs by increasing sexual agency, increasing the use of condoms and contraception, and promoting healthy relationships and healthy life skills among adolescents.
This arm represents the comparison group. SafeSpace General Health will act as the active comparator, while providing youth with lessons, facts, and resources about general health topics.
Eligibility Criteria
You may qualify if:
- Participants must be assigned female or intersex at birth
- Participants must be youth in the U.S. (14-18 years old)
- Participants must have daily access to an iPhone
You may not qualify if:
- \- Participants must not be currently pregnant or currently trying to become pregnant
- Other Criteria:
- \- The study's priority/preference population is for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Child Trendslead
- Power to Decidecollaborator
- Healthy Teen Networkcollaborator
- MyHealthEd, Inccollaborator
Study Sites (1)
Child Trends
Bethesda, Maryland, 20814, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer Manlove, PhD
Child Trends
- STUDY DIRECTOR
Elizabeth L Cook, MSPH
Child Trends
- PRINCIPAL INVESTIGATOR
Riley Steiner, PhD
Power to Decide
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 21, 2023
Study Start
June 12, 2023
Primary Completion
March 11, 2026
Study Completion (Estimated)
September 29, 2026
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share