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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06043596
Other study ID # 1309
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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