持続可能性と精密予防プロジェクト
エビデンスに基づいたHIV予防プログラムの全国的実装：マルチレベルスケールアップ戦略と精密予防
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Deogwoon Kim, PhD
- メール：deogwoon.kim13@umassmed.edu
研究連絡先のバックアップ
- 名前：Lynette Deveaux
- 電話番号：1-242-454-8488
- メール：lyndeveaux@yahoo.com
研究場所
-
-
-
Nassau、バハマ
- 募集
- HIV/AIDS Office, FOY program
-
コンタクト：
- Lynette Deveaux
- 電話番号：1-242-454-8488
- メール：lyndeveaux@yahoo.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Stage 1
All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1). |
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. |
|
実験的：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. |
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. School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers. 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. |
|
実験的：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. |
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. School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers. 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. 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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fidelity of Implementation
時間枠：Years 1, 2, 3, and 4
|
Adherence to the core activities (number of core activities taught as intended) |
Years 1, 2, 3, and 4
|
|
Sustainability
時間枠：Year 4
|
Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years |
Year 4
|
|
Sustainment determinants
時間枠：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. |
Years 1 and 3
|
|
Inner and outer context factors affecting implementation
時間枠：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. |
Yeasr 1 and 3
|
|
School implementation climate
時間枠：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. |
Years 1 and 3
|
|
Condom use skills
時間枠：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. |
Years 1, 2, 3, and 4
|
|
Self-efficacy
時間枠：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. |
Years 1, 2, 3, and 4
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|
Condom use
時間枠：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) |
Years 1, 2, 3, and 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Youth risk and protective behaviors
時間枠：Years 1, 2, and 4
|
The Health-Risk and Protective Factors (HRPF) survey |
Years 1, 2, and 4
|
|
Youth sensation seeking
時間枠：Years 1, 2, 3, and 4
|
The Health-Risk and Protective Factors (HRPF) survey |
Years 1, 2, 3, and 4
|
|
Neighborhood risk
時間枠：Years 1, 2, 3, and 4
|
The Health-Risk and Protective Factors (HRPF) survey |
Years 1, 2, 3, and 4
|
協力者と研究者
協力者
捜査官
- 主任研究者：Bo Wang, PhD、UMass Chan Medical School
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00002463
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All IPD collected during the trial, after deidentification.
IPD 共有時間枠
Immediately following publication. No end date.
IPD 共有アクセス基準
Anyone who wishes to access the data
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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