Actively Recruiting

Phase Not Applicable
Age: 14Years - 18Years
FEMALE
Healthy Volunteers
ID06043596

Evaluation of the SafeSpace App Intervention for Sexual and General Health in Youth Assigned Female or Intersex at Birth

Led by Child Trends · Updated on 2023-11-21

1000

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

Sponsors

C

Child Trends

Lead Sponsor

P

Power to Decide

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the SafeSpace Sexual Health App, a sexual health promotion program designed to reduce sexual risk factors and improve sexual and reproductive health among young people assigned female or intersex at birth. The study particularly focuses on Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates, and youth living in rural communities. This randomized control trial compares the effects of the SafeSpace Sexual Health program with a control app focusing on general health. The study includes two groups: one using the SafeSpace Sexual Health app and the other using the SafeSpace General Health app. Both programs last 10 weeks and are delivered via a secure mobile app. The Sexual Health program covers topics like healthy relationships, anatomy, identity, STIs/HIV, pregnancy, decision-making, personal safety, communication, and healthcare access through youth-written stories, expert facts, reflection prompts, and resources. The control app covers general health topics such as self-care, stress, sleep, nutrition, physical activity, substance use, and social media, with lessons delivered weekly. Participants are asked to keep the app on their device and engage regularly for 10 weeks, receive up to three push notifications weekly, and provide contact information. They complete three online surveys: at the start, after 10 weeks, and nine months later. Occasional text messages from the study team support engagement. Researchers will measure outcomes like condom or contraception use during sex, sexual health service use, discussions about sexual health with trusted adults, and sexual agency. The study runs until September 2026.

CONDITIONS

Brief Title

Evaluation of the SafeSpace App Intervention

Who Can Participate

Age: 14Years - 18Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be assigned female or intersex at birth
  • Participants must be youth in the U.S. aged 14 to 18 years
  • Participants must have daily access to an iPhone
Not Eligible

You will not qualify if you...

  • Participants must not be currently pregnant
  • Participants must not be currently trying to become pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - 10 weeks

Participants engage in a 10-week app-based program focusing on sexual health or general health education delivered through the SafeSpace app.

Weekly app-based lessons with no in-person visits required

Follow-up

Duration - Up to 9 months post-intervention

Participants complete follow-up assessments to evaluate outcomes related to sexual behavior, health service utilization, and sexual agency.

Periodic remote assessments without in-person visits

Trial Site Locations

Total: 1 location

1

Child Trends

Bethesda, Maryland, United States, 20814

Actively Recruiting

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Research Team

E

Elizabeth Cook, MSPH

J

Jennifer Manlove, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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