Sustainability and Precision Prevention Project

NCT07153042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3705

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Sustainability

Interventions

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Ministry of Health, Bahamas

    collaborator UNKNOWN
  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Bo Wang, PhD · UMass Chan Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2029-08-31
Completion
2029-11-30

Countries

  • The Bahamas

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153042 on ClinicalTrials.gov