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Behavioral Intervention

SafeSpace App Intervention for Sexually Transmitted Infections (SafeSpace Trial)

N/A

Recruiting

Led By Riley Steiner, PhD

Research Sponsored by Child Trends

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth must not be currently pregnant or currently trying to become pregnant

Youth must be 14 to 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

SafeSpace Trial Summary

This trial will measure the impacts of using an app to promote sexual and reproductive health & wellbeing among young people assigned female/intersex.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves using an educational app rather than medication, traditional physical side effects are not expected; however, participants may experience increased screen time.

SafeSpace Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant nor trying to conceive.

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I am between 14 and 18 years old.

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I was assigned female or intersex at birth.

SafeSpace Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Penile-vaginal sex without a condom or a more effective method of contraception

Secondary outcome measures

Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.

Penile-vaginal sex or anal sex without a condom every time

Sexual agency during every recent sexual experience or no recent sexual experiences

+1 more

SafeSpace Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SafeSpace Sexual HealthExperimental Treatment1 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 HealthActive Control1 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Child TrendsLead Sponsor

16 Previous Clinical Trials

202,574 Total Patients Enrolled

Power to DecideOTHER

1 Previous Clinical Trials

634 Total Patients Enrolled

Healthy Teen NetworkOTHER

2 Previous Clinical Trials

3,621 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become involved in this research initiative?

"This research program requires participants to possess healthy habits and be aged between 14 and 18. Approximately 1000 participants are needed for the trial's success."

Answered by AI

Is this trial still accepting new participants?

"This trial, which was first posted on June 12th 2023 is still in the process of recruiting patients. The most recent update to the study's information occured on September 12th 2023."

Answered by AI

Does this clinical trial allow for minors to participate?

"The trial's inclusion criteria mandates that participants are aged 14 to 18. This study has recruited 55 people fitting this age bracket and 105 individuals who surpass the upper threshold of 65 years old."

Answered by AI

How many participants are being accepted into this clinical trial?

"Affirmative, the data hosted on clinicaltrials.gov corroborates that this trial is actively recruiting participants. The research study was inaugurated on June 12th 2023 and has been revised most recently on September 12th of the same year. 1000 patients are needed to be enrolled from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the SafeSpace App Intervention

2023. "Evaluation of the SafeSpace App Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043596.