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NCT Number: NCT06043596

Evaluation of the SafeSpace App Intervention

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.

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Key information

Conditions

Health Behavior Behavior Communicable Diseases Disease Attributes Genital Diseases Health Care Utilization Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Infections Treatment Adherence and Compliance Unprotected Sex Unsafe Sex Urogenital Diseases

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Child Trends

Bethesda, Maryland, 20814, United States

Location status: Recruiting

Location contact

Elizabeth Cook

CONTACT

[email protected]

240-223-9323

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SafeSpace Sexual Health

Behavioral

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 Health

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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.

    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

  3. 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

    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

  4. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Cook, MSPH

CONTACT

[email protected]

240-223-9323

Jennifer Manlove, PhD

CONTACT

[email protected]

240-223-9262

Sponsors and collaborators

Lead sponsor

Child Trends

Other

Collaborators

  • Healthy Teen Network
  • MyHealthEd, Inc
  • Power to Decide

Registry information

Acronym: SafeSpace

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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