Evaluation of the SafeSpace App Intervention
NCT06043596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2023-11-21
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.
Conditions
- Health Behavior
- Health Care Utilization
- Unprotected Sex
- Sexually Transmitted Infections
Interventions
- BEHAVIORAL
-
SafeSpace Sexual Health
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.
- BEHAVIORAL
-
SafeSpace General Health
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.
Sponsors & Collaborators
-
Power to Decide
collaborator OTHER -
Healthy Teen Network
collaborator OTHER -
MyHealthEd, Inc
collaborator UNKNOWN -
Child Trends
lead OTHER
Principal Investigators
-
Jennifer Manlove, PhD · Child Trends
-
Elizabeth L Cook, MSPH · Child Trends
-
Riley Steiner, PhD · Power to Decide
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-12
- Primary Completion
- 2026-03-11
- Completion
- 2026-09-29
Countries
- United States
Study Locations
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