National Implementation of an Evidence-Based HIV Prevention Program: Multilevel Scale-Up Strategies and Precision Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,705
- 试验地点
- 1
- 主要终点
- Fidelity of Implementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fidelity of Implementation
时间窗: Years 1, 2, 3, and 4
Adherence to the core activities (number of core activities taught as intended)
Sustainability
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Years 1, 2, 3, and 4
Adherence to the core activities (number of core activities taught as intended)
Sustainability
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Bo Wang
Professor
University of Massachusetts, Worcester