Health BehaviorSafeSpaceNCT06043596
Evaluation of the SafeSpace App Intervention
A study testing SafeSpace Sexual Health and SafeSpace General Health in people with Health Behavior and Health Care Utilization, run by Child Trends at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Care Utilization, Unprotected Sex
- What is being tested?
- SafeSpace Sexual Health and SafeSpace General Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Child Trends
Bethesda, Maryland, 20814
Elizabeth Cook, 240-223-9323, ecook@childtrends.org
About this study
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.
- Conditions
- Health Behavior, Health Care Utilization, Unprotected Sex, Sexually Transmitted Infections
- Being tested
- SafeSpace Sexual Health, SafeSpace General Health
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care, Unsafe Sex, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeSpace Sexual HealthBehavioural
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.
SafeSpace General HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SafeSpace Sexual Health | Experimental | 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. Receives: Behavioral: SafeSpace Sexual Health |
| SafeSpace General Health | Active comparator | 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. Receives: Behavioral: SafeSpace General Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Past 3 months at baseline; past 9 months at long-term follow-up
Secondary outcomes (4)
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
Measured: Past 3 months at baseline; past 9 months at long-term follow-up
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
Measured: 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.
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
Measured: 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
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
Measured: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start12 Jun 2023
- Primary completion11 Mar 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Collaborators
- Power to Decide, Healthy Teen Network, MyHealthEd, Inc
- Responsible party
- Sponsor
- Investigators
- Jennifer Manlove, PhD, Study director, Child TrendsElizabeth L Cook, MSPH, Study director, Child TrendsRiley Steiner, PhD, Principal investigator, Power to Decide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043596
- Sponsor's protocol ID
- 1309
- Acronym
- SafeSpace
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SafeSpace App Intervention
- ClinicalTrials.gov ID
- NCT06043596
- Acronym / sponsor ID
- SafeSpace / 1309
- Conditions
- Health Behavior, Health Care Utilization, Unprotected Sex, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Collaborators
- Power to Decide, Healthy Teen Network, MyHealthEd, Inc
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 11 Mar 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| SafeSpace Sexual Health | Experimental | Behavioral: SafeSpace Sexual HealthThe 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. |
| SafeSpace General Health | Active comparator | Behavioral: SafeSpace General HealthParticipants 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Participants must not be currently pregnant or currently trying to become pregnant
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeSpace Sexual HealthThe 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. | Behavioural | SafeSpace Sexual Health |
| SafeSpace General HealthThis 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. | Behavioural | SafeSpace General Health |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Manlove, PhD study director
Child Trends
Elizabeth L Cook, MSPH study director
Child Trends
Riley Steiner, PhD principal investigator
Power to Decide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeSpace Sexual Health and SafeSpace General Health in people with Health Behavior and Health Care Utilization, run by Child Trends at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Cook, MSPH (240-223-9323, ecook@childtrends.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.