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Evaluation of the SafeSpace App Intervention (SafeSpace)

Primary Purpose

Health Behavior, Health Care Utilization, Unprotected Sex

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SafeSpace Sexual Health
SafeSpace General Health
Sponsored by
Child Trends
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

The study's priority population is youth in the U.S. who were assigned female or intersex at birth with a preference for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas. To participate, youth must not be currently pregnant or currently trying to become pregnant, be 14 to 18 years old, have been assigned female or intersex at birth, and have daily access to an iPhone.

Sites / Locations

  • Child TrendsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SafeSpace Sexual Health

SafeSpace General Health

Arm Description

The proposed intervention is a 10-week app-based program, SafeSpace Sexual Health. SafeSpace Sexual Health will be implemented using a secure, anonymous mobile app that uses authentic stories to engage young people with sexual health information and resources. The program addresses healthy relationships, anatomy and physiology, identity, adolescent development, STIs/HIV, pregnancy and reproduction, decision-making, personal safety, communication, and accessing healthcare. Each lesson includes a story written by youth with lived experience, two to three key facts developed by sexual health experts, a reflection prompt, and two to three reputable resources.

Participants in the control condition will participate in a 10-week app-based general health program, SafeSpace General Health. Lessons address general health topics including self-care, stress, sleep, nutrition, physical activity, substance use, driving and seatbelt use, and social media. Each lesson contains 2-3 key facts created by public health experts and reputable resources. Similar to SafeSpace Sexual Health, youth will receive SafeSpace General Health over 10 weeks, although SafeSpace General Health includes one lesson per week and does not contain youth stories or reflection prompts.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Communication with a friend, partner, family member, or other trusted person about sexual and reproductive health.
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
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

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Child Trends
Collaborators
Power to Decide, Healthy Teen Network, MyHealthEd, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT06043596
Brief Title
Evaluation of the SafeSpace App Intervention
Acronym
SafeSpace
Official Title
Evaluation of the SafeSpace App Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
March 11, 2026 (Anticipated)
Study Completion Date
September 29, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Child Trends
Collaborators
Power to Decide, Healthy Teen Network, MyHealthEd, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Health Care Utilization, Unprotected Sex, Sexually Transmitted Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SafeSpace Sexual Health
Arm Type
Experimental
Arm Description
The proposed intervention is a 10-week app-based program, SafeSpace Sexual Health. SafeSpace Sexual Health will be implemented using a secure, anonymous mobile app that uses authentic stories to engage young people with sexual health information and resources. The program addresses healthy relationships, anatomy and physiology, identity, adolescent development, STIs/HIV, pregnancy and reproduction, decision-making, personal safety, communication, and accessing healthcare. Each lesson includes a story written by youth with lived experience, two to three key facts developed by sexual health experts, a reflection prompt, and two to three reputable resources.
Arm Title
SafeSpace General Health
Arm Type
Active Comparator
Arm Description
Participants in the control condition will participate in a 10-week app-based general health program, SafeSpace General Health. Lessons address general health topics including self-care, stress, sleep, nutrition, physical activity, substance use, driving and seatbelt use, and social media. Each lesson contains 2-3 key facts created by public health experts and reputable resources. Similar to SafeSpace Sexual Health, youth will receive SafeSpace General Health over 10 weeks, although SafeSpace General Health includes one lesson per week and does not contain youth stories or reflection prompts.
Intervention Type
Behavioral
Intervention Name(s)
SafeSpace Sexual Health
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SafeSpace General Health
Intervention Description
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 Measure Information:
Title
Penile-vaginal sex without a condom or a more effective method of contraception
Description
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-up
Secondary Outcome Measure Information:
Title
Penile-vaginal sex or anal sex without a condom every time
Description
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-up
Title
Utilization of sexual health services
Description
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.
Title
Communication with a friend, partner, family member, or other trusted person about sexual and reproductive health.
Description
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
Time Frame
Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Title
Sexual agency during every recent sexual experience or no recent sexual experiences
Description
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-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The study's priority population is youth in the U.S. who were assigned female or intersex at birth with a preference for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas. To participate, youth must not be currently pregnant or currently trying to become pregnant, be 14 to 18 years old, have been assigned female or intersex at birth, and have daily access to an iPhone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Cook, MSPH
Phone
240-223-9323
Email
ecook@childtrends.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Manlove, PhD
Phone
240-223-9262
Email
jmanlove@childtrends.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Manlove, PhD
Organizational Affiliation
Child Trends
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth L Cook, MSPH
Organizational Affiliation
Child Trends
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Riley Steiner, PhD
Organizational Affiliation
Power to Decide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Trends
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cook
Phone
240-223-9323
Email
ecook@childtrends.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the SafeSpace App Intervention

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