Evaluation of the SafeSpace App Intervention

Health Behavior Clinical Trial

— SafeSpace  

Official title:

Evaluation of the SafeSpace App Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043596
• Other study ID #: 1309
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: September 29, 2026

Study information

• Verified date: November 2023
• Source: Child Trends
• Contact: Elizabeth Cook, MSPH
• Phone: 240-223-9323
• Email: ecook[@]childtrends.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 29, 2026
• Est. primary completion date: March 11, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Health Care Utilization
• Sexually Transmitted Diseases
• Sexually Transmitted Infections
• Unprotected Sex

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Child Trends	Bethesda	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Child Trends	Healthy Teen Network, MyHealthEd, Inc, Power to Decide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penile-vaginal sex without a condom or a more effective method of contraception	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	Past 3 months at baseline; past 9 months at long-term follow-up
Secondary	Penile-vaginal sex or anal sex without a condom every time	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	Past 3 months at baseline; past 9 months at long-term follow-up
Secondary	Utilization of sexual health services	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	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.
Secondary	Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.	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. For this scale, there is a minimum score of 0 and a maximum score of 7 with a higher score indicating a better outcome	Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Secondary	Sexual agency during every recent sexual experience or no recent sexual experiences	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	Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up