Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3705 participants
INTERVENTIONAL
2025-10-01
2029-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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Stage 1
All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1).
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.
Stage 2
Based on their performance in Year 1, teachers who do not meet the benchmark (implementing \> 80% of core activities) will be randomized to receive 1) "Biweekly Monitoring and Feedback (BMF)" or 2) "BMF+Site-Based Assistance Mentorship (SAM)." Responders (completing at least 80% of core activities) will continue with UI.
Biweekly monitoring and feedback (BMF)
School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
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.
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.
Stage 3
At the end of Year 2 (stage 2), the performance of the teachers in all three intervention arms will be assessed again. Non-responders in the UI arm will be re-randomized to receive either BMF or BMF+SAM. Non-responders in the BMF-only group will be re-randomized to receive BMF+SAM or BMF+enhanced SAM. Non-responders in the BMF+SAM group will receive BMF+enhanced SAM.
Biweekly monitoring and feedback (BMF)
School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
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.
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.
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.
Interventions
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Biweekly monitoring and feedback (BMF)
School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Students who do not speak or read English sufficiently to participate in study activities.
10 Years
60 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Ministry of Health, Bahamas
UNKNOWN
University of Massachusetts, Worcester
OTHER
Responsible Party
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Bo Wang
Professor
Principal Investigators
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Bo Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
UMass Chan Medical School
Locations
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HIV/AIDS Office, FOY program
Nassau, , The Bahamas
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00002463
Identifier Type: -
Identifier Source: org_study_id
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