Recruiting

SafeSpace App

Sponsor:

Child Trends

Code:

NCT06043596

Conditions

Health Behavior

Health Care Utilization

Unprotected Sex

Sexually Transmitted Infections

Eligibility Criteria

Sex: Female

Age: 14 - 18

Healthy Volunteers: Accepted

Interventions

SafeSpace Sexual Health

SafeSpace General Health

Study Details

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.

Conditions

Health Behavior

Health Care Utilization

Unprotected Sex

Sexually Transmitted Infections

Study ID

NCT06043596

Start date

Jun 12, 2023

Status verified date

Nov, 2023

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Mar 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 18

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 and Locations

Central contacts

Elizabeth Cook, MSPH

240-223-9323ecook@childtrends.org

Jennifer Manlove, PhD

240-223-9262jmanlove@childtrends.org

Locations

Child Trends

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Elizabeth Cook

240-223-9323ecook@childtrends.org

More Information

Sponsor

Child Trends

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Child Trends on 2023-11-21.