Evaluation of the SafeSpace App Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-18
SponsorChild Trends
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
SafeSpace Sexual Health
BehavioralThe 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
BehavioralThis 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: SafeSpace Sexual HealthExperimental treatment 1 intervention
Group B: SafeSpace General HealthActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Past 3 months at baseline; past 9 months at long-term follow-upSecondary outcomes
1
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
Time frame
Past 3 months at baseline; past 9 months at long-term follow-up2
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
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.3
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
Time frame
Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up4
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
Time frame
Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Child Trends
Lead sponsor
Power to Decide
Collaborator
Healthy Teen Network
Collaborator
MyHealthEd, Inc
Collaborator
Source ClinicalTrials.gov