Evaluation of the SafeSpace App Intervention

Обзор

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.

Вмешательства

• Поведенческое SafeSpace Sexual Health
  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.
• Поведенческое SafeSpace General Health
  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.

Первичные конечные точки

• Penile-vaginal sex without a condom or a more effective method of contraception [Срок оценки: Past 3 months at baseline; past 9 months at long-term follow-up]

Вторичные конечные точки (4)

• Penile-vaginal sex or anal sex without a condom every time [Срок оценки: Past 3 months at baseline; past 9 months at long-term follow-up]
• Utilization of sexual health services [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Child Trends — Bethesda

Идентификаторы

NCT: NCT06043596 · 1309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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