National Implementation of an Evidence-Based HIV Prevention Program: Multilevel Scale-Up Strategies and Precision Prevention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,705
- Locations
- 1
- Primary Endpoint
- Fidelity of Implementation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Stage 1
All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1).
Intervention: FOYC+CImPACT (Behavioral)
Stage 2
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.
Intervention: Site-based assistance and mentorship (SAM) (Behavioral)
Stage 2
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.
Intervention: FOYC+CImPACT (Behavioral)
Stage 3
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.
Intervention: Biweekly monitoring and feedback (BMF) (Behavioral)
Stage 3
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.
Intervention: Site-based assistance and mentorship (SAM) (Behavioral)
Stage 3
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.
Intervention: FOYC+CImPACT (Behavioral)
Stage 3
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.
Intervention: Enhanced site-based assistance and mentorship (Enhanced SAM) (Behavioral)
Stage 2
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.
Intervention: Biweekly monitoring and feedback (BMF) (Behavioral)
Outcomes
Primary Outcomes
Fidelity of Implementation
Time Frame: Years 1, 2, 3, and 4
Adherence to the core activities (number of core activities taught as intended)
Sustainability
Time Frame: Year 4
Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years
Sustainment determinants
Time Frame: Years 1 and 3
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.
Inner and outer context factors affecting implementation
Time Frame: Yeasr 1 and 3
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.
School implementation climate
Time Frame: Years 1 and 3
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.
Condom use skills
Time Frame: Years 1, 2, 3, and 4
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.
Self-efficacy
Time Frame: Years 1, 2, 3, and 4
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.
Fidelity of Implementation
Time Frame: Years 1, 2, 3, and 4
Adherence to the core activities (number of core activities taught as intended)
Sustainability
Time Frame: Year 4
Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years
Sustainment determinants
Time Frame: Years 1 and 3
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.
Inner and outer context factors affecting implementation
Time Frame: Yeasr 1 and 3
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.
School implementation climate
Time Frame: Years 1 and 3
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.
Condom use skills
Time Frame: Years 1, 2, 3, and 4
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.
Self-efficacy
Time Frame: Years 1, 2, 3, and 4
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.
Condom use
Time Frame: Years 1, 2, 3, and 4
Self-reported condom use in the last sexual intercourse and frequency of condom use in general (always, often, sometimes, or never)
Secondary Outcomes
- 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)
Investigators
Bo Wang
Professor
University of Massachusetts, Worcester