Evaluation of the SafeSpace App Intervention

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Child Trends
Study ID
NCT06043596
Status
Recruiting
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Conditions

  • Health Behavior
  • Health Care Utilization
  • Sexually Transmitted Infections
  • Unprotected Sex

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • SafeSpace Sexual Health — BEHAVIORAL
    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.
  • SafeSpace General Health — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Nov 2023
Primary completion
Mar 11, 2026
Completion
Sep 29, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: SafeSpace Sexual Health
    The 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.
  • Active Comparator: SafeSpace General Health
    Participants 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.

Primary Outcome Measure

Penile-vaginal sex without a condom or a more effective method of contraception [ Time Frame: Past 3 months at baseline; past 9 months at long-term follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Child TrendsBethesdaMaryland20814
Elizabeth Cook
[email protected]
240-223-9323

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Child Trends· Bethesda, MD

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