Sustainability and Precision Prevention Project

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Sustainability

Treatments: 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)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07153042

STUDY00002463

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,705 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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3,705 participants in 3 patient groups

Stage 1

Experimental group

Description:

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

Treatment:

Behavioral: FOYC+CImPACT

Stage 2

Experimental group

Description:

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.

Treatment:

Behavioral: Site-based assistance and mentorship (SAM)

Behavioral: FOYC+CImPACT

Behavioral: Biweekly monitoring and feedback (BMF)

Stage 3

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced site-based assistance and mentorship (Enhanced SAM)

Behavioral: Site-based assistance and mentorship (SAM)

Behavioral: FOYC+CImPACT

Behavioral: Biweekly monitoring and feedback (BMF)