NCT06043596 Evaluation of the SafeSpace App Intervention
| NCT ID | NCT06043596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Child Trends |
| Condition | Health Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2026-03-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-06-12 with a primary completion date of 2026-03-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- 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 & Investigator
Jennifer Manlove, PhD
STUDY DIRECTOR
Child Trends
Frequently Asked Questions
Who can join the NCT06043596 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 18 Years, studying Health Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06043596 currently recruiting?
Yes, NCT06043596 is actively recruiting participants. Contact the research team at ecook@childtrends.org for enrollment information.
Where is the NCT06043596 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06043596 clinical trial?
NCT06043596 is sponsored by Child Trends. The principal investigator is Jennifer Manlove, PhD at Child Trends. The trial plans to enroll 1,000 participants.