Sustainability and Precision Prevention Project

NCT07153042 | Recruiting

• 1 other identifier: STUDY00002463
• Study Type: interventional
• Target: 3,705
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

Secondary Outcomes (3)

• Youth risk and protective behaviors

  Years 1, 2, and 4

• Youth sensation seeking

  Years 1, 2, 3, and 4

• Neighborhood risk

  Years 1, 2, 3, and 4

Study Arms (3)

Stage 1

EXPERIMENTAL

All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1).

Behavioral: FOYC+CImPACT

Stage 2

EXPERIMENTAL

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: Biweekly monitoring and feedback (BMF); Behavioral: Site-based assistance and mentorship (SAM); Behavioral: FOYC+CImPACT

Stage 3

EXPERIMENTAL

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: Biweekly monitoring and feedback (BMF); Behavioral: Site-based assistance and mentorship (SAM); Behavioral: Enhanced site-based assistance and mentorship (Enhanced SAM); Behavioral: FOYC+CImPACT

Interventions

Biweekly monitoring and feedback (BMF) BEHAVIORAL

School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.

Stage 2; Stage 3

Site-based assistance and mentorship (SAM) BEHAVIORAL

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.

Stage 2; Stage 3

Enhanced site-based assistance and mentorship (Enhanced SAM) BEHAVIORAL

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.

Stage 3

FOYC+CImPACT BEHAVIORAL

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 1; Stage 2; Stage 3

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Ministry of Health, Bahamas: collaborator

Study Sites (1)

HIV/AIDS Office, FOY program

Nassau, The Bahamas

RECRUITING

Study Officials

• Bo Wang, PhD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynette Deveaux

CONTACT

1-242-454-8488; lyndeveaux@yahoo.com

Deogwoon Kim, PhD

CONTACT

deogwoon.kim13@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

TH (1)