Clinical trial NCT06043596: Evaluation of the SafeSpace App Intervention
Official title: Evaluation of the SafeSpace App Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Health Care Utilization
Unprotected Sex
Sexually Transmitted Infections
Lead sponsor: Child Trends
Sponsor class: OTHER
Collaborators: name: Power to Decide
name: Healthy Teen Network
name: MyHealthEd, Inc
First posted: 2023-09-21
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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.


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.

Primary outcomes:
measure: Penile-vaginal sex without a condom or a more effective method of contraception
timeFrame: Past 3 months at baseline; past 9 months at long-term follow-up
Secondary outcomes:
measure: Penile-vaginal sex or anal sex without a condom every time
timeFrame: Past 3 months at baseline; past 9 months at long-term follow-up
measure: Utilization of sexual health services
timeFrame: 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.
measure: Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.
timeFrame: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
measure: Sexual agency during every recent sexual experience or no recent sexual experiences
timeFrame: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Child Trends
state: Maryland
Study officials:
affiliation: Child Trends
name: Jennifer Manlove, PhD
role: STUDY_DIRECTOR
affiliation: Child Trends
name: Elizabeth L Cook, MSPH
role: STUDY_DIRECTOR
affiliation: Power to Decide
name: Riley Steiner, PhD
role: PRINCIPAL_INVESTIGATOR
References: