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Sustainability and Precision Prevention Project

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07153042
Enrollment
3705
Registered
2025-09-03
Start date
2025-10-01
Completion date
2029-11-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sustainability

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.

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.

Interventions

BEHAVIORALBiweekly monitoring and feedback (BMF)

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

BEHAVIORALSite-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.

BEHAVIORALEnhanced 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.

BEHAVIORALFOYC+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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Ministry of Health, Bahamas
CollaboratorUNKNOWN
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Condom useYears 1, 2, 3, and 4Self-reported condom use in the last sexual intercourse and frequency of condom use in general (always, often, sometimes, or never)
School implementation climateYears 1 and 3The 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.
Condom use skillsYears 1, 2, 3, and 4The 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.
Self-efficacyYears 1, 2, 3, and 4A 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.
Fidelity of ImplementationYears 1, 2, 3, and 4Adherence to the core activities (number of core activities taught as intended)
SustainabilityYear 4Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years
Sustainment determinantsYears 1 and 3The 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.
Inner and outer context factors affecting implementationYeasr 1 and 3The 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.

Secondary

MeasureTime frameDescription
Youth sensation seekingYears 1, 2, 3, and 4The Health-Risk and Protective Factors (HRPF) survey
Neighborhood riskYears 1, 2, 3, and 4The Health-Risk and Protective Factors (HRPF) survey
Youth risk and protective behaviorsYears 1, 2, and 4The Health-Risk and Protective Factors (HRPF) survey

Countries

The Bahamas

Contacts

Primary ContactLynette Deveaux
lyndeveaux@yahoo.com1-242-454-8488
Backup ContactDeogwoon Kim, PhD
deogwoon.kim13@umassmed.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026