Health TrialsbyHealthPanel

Sustainability and Precision Prevention Project

ConditionSustainability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-60
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Biweekly monitoring and feedback (BMF)

    Behavioral

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

  • 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.

  • 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.

  • 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.

Treatment groups

3,705 Participants
are divided into 3 treatment groups
Group A: Stage 1Experimental treatment 1 intervention
Group B: Stage 2Experimental treatment 3 interventions
Group C: Stage 3Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Fidelity of Implementation

Adherence to the core activities (number of core activities taught as intended)

Time frame
Years 1, 2, 3, and 4
2

Sustainability

Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years

Time frame
Year 4
3

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.

Time frame
Years 1 and 3
4

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.

Time frame
Yeasr 1 and 3

Secondary outcomes

1

Youth risk and protective behaviors

The Health-Risk and Protective Factors (HRPF) survey

Time frame
Years 1, 2, and 4
2

Youth sensation seeking

The Health-Risk and Protective Factors (HRPF) survey

Time frame
Years 1, 2, 3, and 4
3

Neighborhood risk

The Health-Risk and Protective Factors (HRPF) survey

Time frame
Years 1, 2, 3, and 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

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

Collaborator

Ministry of Health, Bahamas

Collaborator

Source ClinicalTrials.gov
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