Sustainability and Precision Prevention Project

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sustainability
• Intervention / Treatment: Behavioral: FOYC+CImPACT; Behavioral: Biweekly monitoring and feedback (BMF); Behavioral: Site-based assistance and mentorship (SAM); Behavioral: Enhanced site-based assistance and mentorship (Enhanced SAM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 3705
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deogwoon Kim, PhD; Email: deogwoon.kim13@umassmed.edu
• Study Contact Backup: Name: Lynette Deveaux; Phone Number: 1-242-454-8488; Email: lyndeveaux@yahoo.com

Study Locations

• The Bahamas
  • Nassau, The Bahamas
    • Recruiting
    • HIV/AIDS Office, FOY program
    • Contact: Lynette Deveaux; Phone Number: 1-242-454-8488; Email: lyndeveaux@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1; All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1).	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.
Experimental: 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.	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.; 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.
Experimental: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity of Implementation	Adherence to the core activities (number of core activities taught as intended)	Years 1, 2, 3, and 4
Sustainability	Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years	Year 4
Condom use	Self-reported condom use in the last sexual intercourse and frequency of condom use in general (always, often, sometimes, or never)	Years 1, 2, 3, and 4
Sustainment determinants	The Sustainment Measurement System Scale (SMSS) is a 35-item instrument that evaluates sustainment determinants and outcomes (one sustainment outcome subscale and seven determinant domain subscales). Items are rated on a 5-point scale, from 1 = Little or no extent to 5 = Great extent. Subscale scores are calculated as the average of the items within the subscale, ranging from 1 to 5. Higher scores on all subscales indicate greater agreement with the subscale.	Years 1 and 3
Inner and outer context factors affecting implementation	The Program Sustainability Assessment Tools (PSAT) is an eight-domain, 40-item instrument that assesses a program's capacity for sustainability. Items are rated on a 7-point scale from 1 = Little or no extent to 7 = A very great extent. Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 1-7). Higher scores indicate a great level of sustainability capacity.	Yeasr 1 and 3
School implementation climate	The School Implementation Climate Scale (SICS) is a seven-domain, 21-item instrument assessing a school's climate for implementing an evidence-based practice. Items are rated on a 5-point scale (0 = Not at all; 4 = Very great extent). Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 0-4). Higher scores indicate a more favorable implementation climate.	Years 1 and 3
Condom use skills	The Condom-Use Skills Checklist is an 8-item scale assessing youth's understanding of correct condom use. Each item is answered True/False. Scores are calculated as the total number of correct responses. Scores range from 0 to 8, with higher scores indicating greater knowledge of condom-use skills.	Years 1, 2, 3, and 4
Self-efficacy	A 5-item self-efficacy for condom use scale will be utilized to assess students' self-perceived ability to use condoms. Items are rated on a 5-point scale (1 = Strongly disagree; 5 = Strongly agree). Scores are calculated as the average of all items, with a range of 1 to 5. Higher scores indicate greater self-efficacy for condom use.	Years 1, 2, 3, and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Youth risk and protective behaviors	The Health-Risk and Protective Factors (HRPF) survey	Years 1, 2, and 4
Youth sensation seeking	The Health-Risk and Protective Factors (HRPF) survey	Years 1, 2, 3, and 4
Neighborhood risk	The Health-Risk and Protective Factors (HRPF) survey	Years 1, 2, 3, and 4

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ministry of Health, Bahamas
• Investigators: Principal Investigator: Bo Wang, PhD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: August 25, 2025
• First Submitted That Met QC Criteria: August 25, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No