Evaluation of the SafeSpace App Intervention

Sponsor
Child Trends (Other)
Overall Status
Recruiting
CT.gov ID
NCT06043596
Collaborator
Power to Decide (Other), Healthy Teen Network (Other), MyHealthEd, Inc (Other)
1,000
1
2
39.6
25.3

Study Details

Study Description

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.

We 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SafeSpace Sexual Health
  • Behavioral: SafeSpace General Health
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This research project will use an individual randomized controlled trial design in which youth recruited from social media ads will be randomized 1:1 into the experimental condition (about sexual health) and the control condition (about general health).This research project will use an individual randomized controlled trial design in which youth recruited from social media ads will be randomized 1:1 into the experimental condition (about sexual health) and the control condition (about general health).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of the SafeSpace App Intervention
Actual Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Mar 11, 2026
Anticipated Study Completion Date :
Sep 29, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

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

    Yes = Had penile-vaginal sex without using pill, shot, patch, ring, IUD, implant, or condom every time; No = Did not have penile-vaginal sex OR always used pill, shot, patch, ring, IUD, implant, or condom during penile-vaginal sex

Secondary Outcome Measures

  1. Penile-vaginal sex or anal sex without a condom every time [Past 3 months at baseline; past 9 months at long-term follow-up]

    Yes = Had penile-vaginal sex or anal sex without using a condom every time OR had anal sex without use of a condom every time. No = No penile-vaginal sex AND no anal sex; or No = No penile-vaginal sex AND condom use during anal sex every time; or No = condom use during every penile vaginal sex AND no anal sex

  2. Utilization of sexual health services [Has received SRH services in the past 12 months or has an appointment scheduled in the next 3 months at baseline; Received SRH services in the past 9 months or has an appointment scheduled in the next 3 months at long-term follow-up.]

    Yes = has seen a health care provider (clinic or doctor's office) for any sexual or reproductive health services in the past 12 months No = did not see a health care provider for SRH services in the past 12 months

  3. Communication with a friend, partner, family member, or other trusted person about sexual and reproductive health. [Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up]

    Score of talking with trusted person in the past 3 months about topic categories including either sexual orientation or gender identity; when to have sex; receiving SRH services; STIs and contraception; consent or pleasure in the past 3 months

  4. Sexual agency during every recent sexual experience or no recent sexual experiences [Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up]

    Dependent on the frequency of a) communicating with their partners(s) about what they like, dislike, or want to try, b) asking their partner(s) what they like, dislike, or want to try, and c) asking or giving consent to their partner(s). Those who haven't engaged in sexual activity within the relevant time frame will be considered to have sexual agency

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 18 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

The study's priority population is youth in the U.S. who were assigned female or intersex at birth with a preference for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas.

To participate, youth must not be currently pregnant or currently trying to become pregnant, be 14 to 18 years old, have been assigned female or intersex at birth, and have daily access to an iPhone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Child Trends Bethesda Maryland United States 20814

Sponsors and Collaborators

  • Child Trends
  • Power to Decide
  • Healthy Teen Network
  • MyHealthEd, Inc

Investigators

  • Study Director: Jennifer Manlove, PhD, Child Trends
  • Study Director: Elizabeth L Cook, MSPH, Child Trends
  • Principal Investigator: Riley Steiner, PhD, Power to Decide

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Child Trends
ClinicalTrials.gov Identifier:
NCT06043596
Other Study ID Numbers:
  • 1309
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023