Evaluation of the SafeSpace App Intervention

Child Trends

Status: Enrolling

Conditions: Sexually Transmitted Infections; Unprotected Sex; Health Behavior; Health Care Utilization

Treatments: Behavioral: SafeSpace Sexual Health; Behavioral: SafeSpace General Health

Study type: Interventional

Funder types: Other

Identifiers

NCT06043596

1309

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

SafeSpace Sexual Health

Experimental group

Description:

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.

Treatment:

Behavioral: SafeSpace Sexual Health

SafeSpace General Health

Active Comparator group

Description:

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.

Treatment:

Behavioral: SafeSpace General Health