NCT07153042

Sustainability and Precision Prevention Project

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,705 (estimated)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sustainability

Interventions

Type	Name	Description
BEHAVIORAL	Biweekly monitoring and feedback (BMF)	School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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 parent-adolescent communication and listening strategies related to difficult topics including "safe-sex" followed by two role-plays for the parent and youth, a discussion, and a condom demonstration.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-08-31
• Completion: 2029-11-30
• First posted: 2025-09-03
• Last updated: 2025-11-17

Locations

1 site across 1 country: The Bahamas