Sustainability and Precision Prevention Project

Официальное название

National Implementation of an Evidence-Based HIV Prevention Program: Multilevel Scale-Up Strategies and Precision Prevention

Обзор

This is a five-year hybrid type 3 effectiveness-implementation study evaluating multilevel strategies to sustain a nationwide implementation of an evidence-based HIV prevention curriculum in schools. Advanced machine learning methods are being used to enhance implementation strategies. A Sequential, Multiple Assignment, Randomized Trial (SMART) design will be employed.

Подробное описание

A hybrid type 3 effectiveness-implementation study is proposed, using a SMART adaptive implementation trial that will evaluate the value of multilevel strategies to sustain Focus on Youth in Caribbean + Caribbean Informed Parents and Children Together (FOYC+CImPACT) in schools and harness advanced machine learning to help promote the FOYC+CImPACT sustainability by iteratively enriching implementation strategies. This study will also identify the most effective implementation strategy for teachers who implement \<80% of core activities and for adolescents who are unlikely to respond to FOYC+CImPACT by using machine learning approaches. The primary outcome is program sustainability. Data from teachers, students, and focus groups will provide information on inner and outer contexts, strategies to promote implementation and sustainability, and program effectiveness.

Primary implementation of FOYC+CImPACT will be conducted by 156 grade-6 teachers in 65 government primary schools across four years. Annual FOYC booster sessions for students will be conducted by 49 Health and Family Life Education (HFLE) teachers in 30 junior high schools. Approximately 3,500 students will complete the full curricular assessment survey at the beginning and end of grade 6 and at the end of grades 7, 8, and 9.

Вмешательства

• Поведенческое Biweekly monitoring and feedback (BMF)
  School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
• Поведенческое Site-based assistance and mentorship (SAM)
  High-performing teachers will serve as team leaders and guide non-responding teachers on preparation and planning. The team leader will promote group activities and enhance interaction among teachers in these meetings.
• Поведенческое Enhanced site-based assistance and mentorship (Enhanced SAM)
  A FOYC coach (with FOYC implementation and training experience) will provide tailored in-person support, facilitate goal-setting, opportunities to interact with consultants, supportive text messaging, continuing education, networking strategies, and monthly check-ins.
• Поведенческое FOYC+CImPACT
  Focus on Youth in the Caribbean (FOYC) is an evidence-based, eight-session life skills curriculum designed to reduce risk-taking behaviors related to HIV/STI transmission and teen pregnancy. Woven throughout FOYC is a decision-making model that provides guidance and practice in problem solving with a focus on how to obtain factual information on sexual health. CImPACT is a single-session intervention including a 24-min educational video filmed in The Bahamas. The video focuses on effective pare

Первичные конечные точки

• Fidelity of Implementation [Срок оценки: Years 1, 2, 3, and 4]
• Sustainability [Срок оценки: Year 4]
• Sustainment determinants [Срок оценки: Years 1 and 3]
• Inner and outer context factors affecting implementation [Срок оценки: Yeasr 1 and 3]
• School implementation climate [Срок оценки: Years 1 and 3]
• Condom use skills [Срок оценки: Years 1, 2, 3, and 4]
• Self-efficacy [Срок оценки: Years 1, 2, 3, and 4]
• Condom use [Срок оценки: Years 1, 2, 3, and 4]

Вторичные конечные точки (3)

• Youth risk and protective behaviors [Срок оценки: Years 1, 2, and 4]
• Youth sensation seeking [Срок оценки: Years 1, 2, 3, and 4]
• Neighborhood risk [Срок оценки: Years 1, 2, 3, and 4]

Критерии участия

Критерии включения

• Grade 6 teachers who teach Health and Family Life Education (HFLE) and their classes in 65 government primary schools.
• Grade 7-9 HFLE teachers and their classes in 30 middle schools across 12 Bahamian islands.
• FOYC (Focus on Youth in the Caribbean) is delivered as part of the standard HFLE curriculum.
• Students who: 1) are enrolled in one of the participating schools as general education students in grade 6 (and followed through grades 7-9); and 2) speak and read English.

Критерии исключения

• Students who chose to opt out of participating in the study
• Students who do not speak or read English sufficiently to participate in study activities.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

The Bahamas · 1 центр

• HIV/AIDS Office, FOY program — Nassau

Идентификаторы

NCT: NCT07153042 · STUDY00002463

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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