Evaluation of the SafeSpace App Intervention

NCT06043596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-11-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Power to Decide

    collaborator OTHER
  • Healthy Teen Network

    collaborator OTHER
  • MyHealthEd, Inc

    collaborator UNKNOWN
  • Child Trends

    lead OTHER

Principal Investigators

  • Jennifer Manlove, PhD · Child Trends

  • Elizabeth L Cook, MSPH · Child Trends

  • Riley Steiner, PhD · Power to Decide

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2026-03-11
Completion
2026-09-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043596 on ClinicalTrials.gov