Evaluation of the SafeSpace App Intervention
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
🗓️ Study Start (Actual) 12 June 2023
🗓️ Primary Completion (Estimated) 11 March 2026
✅ Study Completion (Estimated) 29 September 2026
👥 Enrollment (Estimated) 1000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 14 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 September 2023
  • First Submitted that Met QC Criteria 12 September 2023
  • First Posted 21 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 November 2023
  • Last Update Posted 21 November 2023
  • Last Verified November 2023