Health Behavior, Health Care Utilization, Sexually Transmitted Infections, Unprotected Sex
Conditions
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.
Interventions
BEHAVIORALSafeSpace 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.
BEHAVIORALSafeSpace 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.
Sponsors
Power to Decide
Healthy Teen Network
MyHealthEd, Inc
Child Trends
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penile-vaginal sex without a condom or a more effective method of contraception | Past 3 months at baseline; past 9 months at long-term follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penile-vaginal sex or anal sex without a condom every time | Past 3 months at baseline; past 9 months at long-term follow-up | 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 |
| Utilization of sexual health services | 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. | 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 |
| Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months. | Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up | 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 |
| Sexual agency during every recent sexual experience or no recent sexual experiences | Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up | 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 |
Countries
United States
Contacts
Primary ContactElizabeth Cook, MSPH
Backup ContactJennifer Manlove, PhD
Outcome results
None listed