Sustainability and Precision Prevention Project

Official title

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

Overview

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

• 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.
• 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 pare

Primary outcome measures

• Fidelity of Implementation [Time frame: Years 1, 2, 3, and 4]
• Sustainability [Time frame: Year 4]
• Sustainment determinants [Time frame: Years 1 and 3]
• Inner and outer context factors affecting implementation [Time frame: Yeasr 1 and 3]
• School implementation climate [Time frame: Years 1 and 3]
• Condom use skills [Time frame: Years 1, 2, 3, and 4]
• Self-efficacy [Time frame: Years 1, 2, 3, and 4]
• Condom use [Time frame: Years 1, 2, 3, and 4]

Secondary outcome measures (3)

• Youth risk and protective behaviors [Time frame: Years 1, 2, and 4]
• Youth sensation seeking [Time frame: Years 1, 2, 3, and 4]
• Neighborhood risk [Time frame: Years 1, 2, 3, and 4]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Prevention

Study locations

The Bahamas · 1 center

• HIV/AIDS Office, FOY program — Nassau

Identifiers

NCT: NCT07153042 · STUDY00002463

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗