Evaluation of the SafeSpace App Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SafeSpace Sexual Health, SafeSpace General Health.
- Who it may be relevant to
- Registry conditions: Health Behavior, Health Care Utilization, Unprotected Sex, Sexually Transmitted Infections. Basic parameters: 14 years — 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Penile-vaginal sex without a condom or a more effective method of contraception [Time frame: Past 3 months at baseline; past 9 months at long-term follow-up]
Secondary outcome measures (4)
- Penile-vaginal sex or anal sex without a condom every time [Time frame: Past 3 months at baseline; past 9 months at long-term follow-up]
- Utilization of sexual health services [Time frame: 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.]
- Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months. [Time frame: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up]
- Sexual agency during every recent sexual experience or no recent sexual experiences [Time frame: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Child Trends — Bethesda
Identifiers
NCT: NCT06043596 · 1309