SafeSpace App Intervention for Sexually Transmitted Infections

(SafeSpace Trial)

Overseen By Jennifer Manlove, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Child Trends

Disqualifiers: Pregnancy, Trying to become pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

1000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SafeSpace App Intervention for Sexually Transmitted Infections treatment?

Research shows that digital health tools, like smartphone apps, can help reduce the time it takes for people to be notified and treated for sexually transmitted infections. Additionally, interactive digital interventions have been found to support behavior change, such as increasing condom use, which can help prevent STIs. ^{1 2 3 4 5}

How is the SafeSpace App treatment different from other STI treatments?

The SafeSpace App is unique because it uses a digital platform to provide personalized support for sexual health, allowing users to access information and behavior change tools privately and conveniently on their mobile devices, unlike traditional face-to-face interventions. ^{1 3 6 7 8}

What is the purpose of 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.

Research Team

Jennifer Manlove, PhD

Principal Investigator

Child Trends

Riley Steiner, PhD

Principal Investigator

Power to Decide

Elizabeth L Cook, MSPH

Principal Investigator

Child Trends

Eligibility Criteria

This trial is for U.S. youth aged 14-18, assigned female or intersex at birth, especially Black and/or Latine, LGBTQ+, or those in rural areas with high teen birth rates. Participants need daily iPhone access and must not be pregnant nor trying to conceive.

Inclusion Criteria

I was assigned female or intersex at birth.

You are a young person from an area with elevated teenage birth rates.

I was assigned female or intersex at birth and identify as Black and/or Latine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the SafeSpace app for 10 weeks, receiving push notifications and completing lessons on sexual or general health.

10 weeks

Regular app engagement and push notifications

Short-term Follow-up

Participants complete a short-term follow-up survey 10 weeks after baseline to assess immediate impacts.

1 week

1 online survey

Long-term Follow-up

Participants complete a long-term follow-up survey 9 months after the short-term follow-up to assess sustained impacts.

9 months

1 online survey

Treatment Details

Interventions

• SafeSpace General Health
• SafeSpace Sexual Health

Trial Overview The study tests the SafeSpace Sexual Health App's effectiveness in promoting sexual health and reducing risks among young people compared to a control app focusing on general health. It involves regular app use over 10 weeks and completing surveys over a year.

Participant Groups

Group I: SafeSpace Sexual Health Experimental Treatment 1 Intervention

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.

Group II: SafeSpace General Health Active Control 1 Intervention

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.

SafeSpace Sexual Health is already approved in United States for the following indications:

Approved in United States as SafeSpace App for:

• Sexual health promotion
• Reducing sexual risk factors
• Promoting sexual and reproductive health and wellbeing among young people

Who Is Running the Clinical Trial?

Child Trends

Lead Sponsor

Trials

20

Recruited

208,000+

Power to Decide

Collaborator

Trials

3

Recruited

3,100+

Healthy Teen Network

Collaborator

Trials

3

Recruited

4,600+

MyHealthEd, Inc

Collaborator

Trials

1

Recruited

1,000+

Findings from Research

The Men's Safer Sex (MenSS) website is being tested in a pilot trial with 166 male participants aged 16 and over, aiming to assess its feasibility in increasing condom use and reducing sexually transmitted infections (STIs) among men who have had recent unprotected sex.

The primary outcome of the trial is to measure condom use at 3 months, while STI rates will be tracked through clinic records at 12 months, providing insights into the effectiveness of this digital intervention compared to usual sexual health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

The implementation of the Healthvana platform reduced the average time between STI testing and notification from 8 days to 6 days, indicating improved efficiency in communication.

Overall, the time from STI testing to treatment also decreased from 12 days to 10 days, demonstrating that Healthvana can enhance the speed of STI management in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Application to Reduce Time-to-Notification of Sexually Transmitted Infections. Cohen, AC., Zimmerman, F., Prelip, M., et al.[2019]

Digital health has been effectively used to enhance STI/HIV prevention messaging and increase the accessibility of testing, as shown in a review of 23 studies published between March 2018 and August 2019.

The use of digital platforms has also been linked to improved understanding and uptake of pre-exposure prophylaxis (PrEP), highlighting their potential in optimizing clinical interventions and supporting mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health for sexually transmitted infection and HIV services: a global scoping review. Cao, B., Bao, H., Oppong, E., et al.[2021]

A survey of 616 clients at the Melbourne Sexual Health clinic revealed that 80% had experience with personal computers and expected technology to be utilized in their care.

Only a small percentage of clients (9% for registration, 7% for health details, and 21% for sexual behavior) were unwilling to provide personal information through computer-assisted self-interviews, indicating a general acceptance of technology in sexual health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client acceptability of the use of computers in a sexual health clinic. Tideman, RL., Pitts, MK., Fairley, CK.[2015]

The gamified web application 'sjekkdeg.no' was developed to engage North-Norwegian youngsters in sexual health education and STD prevention, utilizing features like avatars and achievement rewards.

Preliminary results suggest that this interactive approach may effectively encourage users to learn about sexual health and STDs, potentially leading to changes in risky behaviors and a reduction in STD rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification strategy on prevention of STDs for youth. Gabarron, E., Schopf, T., Serrano, JA., et al.[2022]

A mobile health app designed to promote safe sex and increase condom use among youth was developed based on direct input from 17 young participants (15 individual interviews and 2 focus groups) in Stockholm, emphasizing the importance of youth engagement in intervention design.

The app's content includes sex education, practical condom usage tips, and supportive messaging, with various delivery modes suggested by youth, such as text messages and videos, highlighting the need for engaging and relatable educational tools to effectively promote safe sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. Nielsen, A., Bågenholm, A., De Costa, A.[2020]

Out of 1937 mobile apps related to HIV and STDs, only 55 met the criteria for effective prevention and care, with most apps providing basic disease information but lacking comprehensive resources for testing and safer sex practices.

Despite the potential of these apps, they are not widely downloaded or highly rated, indicating a need for public health practitioners to collaborate with developers to enhance their effectiveness and user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone applications for the care and prevention of HIV and other sexually transmitted diseases: a review. Muessig, KE., Pike, EC., Legrand, S., et al.[2021]

The Wrapped intervention, designed for young people aged 16-24 using STI self-sampling websites, aims to increase consistent condom use and reduce STI rates, with a feasibility randomized controlled trial involving at least 230 participants to test its effectiveness.

This study is crucial as it addresses the rising rates of STIs among young people and leverages the growing trend of online STI testing, providing insights that could shape future definitive trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial. Newby, K., Kwah, K., Schumacher, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Smartphone Application to Reduce Time-to-Notification of Sexually Transmitted Infections. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Digital health for sexually transmitted infection and HIV services: a global scoping review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Client acceptability of the use of computers in a sexual health clinic. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Gamification strategy on prevention of STDs for youth. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Mobile phone applications for the care and prevention of HIV and other sexually transmitted diseases: a review. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial. [2023]