A Study to Evaluate the Best Ways to Implement a Community Health Worker-supported Telehealth Program for Managing High Blood Pressure in Kenya (COMPASS)
Community-based Implementation of Hypertension Screening and Telehealth Systems in Kenya
This study will compare two strategies involving community health workers and telehealth to help control high blood pressure among rural residents in Kenya: basic steps including training, developing protocols, and engaging leaders for supervision, compared to these steps plus additional support from healthcare worker champions and support from an outside facilitator. The program will be tested in 16 health centers and their surrounding catchment areas in Kenya to determine which approach works best.
調査の概要
詳細な説明
The study's goal is to examine the implementation and effectiveness of two strategies for integrating a community health worker (CHW)-facilitated hypertension telehealth intervention into routine care at primary health centers operated by Kenya's Ministry of Health (MoH). Investigators will conduct a type 2 hybrid implementation-effectiveness cluster randomized trial across 16 MoH primary health centers and surrounding communities in Homa Bay County to compare the impact of core and enhanced strategies on uptake of CHW telehealth and population-level hypertension control at 18 months. A waiver of consent will be obtained for the collection of data for the primary outcomes. CHWs, clinicians, implementation champions, practice facilitators, clinic directors, CHW supervisors and MOH leadership will take part in the implementation, in-depth interviews and surveys.
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：Douglas Black
- 電話番号：415-806-3016
- メール：douglas.black@ucsf.edu
研究場所
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Mbita、ケニア
- GPRT
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コンタクト：
- Janice Litunya, MBChB
- 電話番号：+254-710-710593
- メール：litunyajaniceo@gmail.com
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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
Patient-Level Inclusion Criteria for Primary Outcome Ascertainment (waiver of consent)
- Adults ≥40 years of age
- Residing within the "Community Unit" served by one of the 16 MoH primary care clinics included in the study
- Hypertension diagnosis (BP ≥140/90 mmHg on average of 2nd and 3rd measures on two separate occasions OR ≥160/100 mmHg on average of 2nd and 3rd measures on a single occasion OR currently on antihypertensive therapy)
Exclusion Criteria:
- None
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Core Strategies
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CHWs and clinicians receive case-based training, MoH leadership supervision, implementation blueprints with medication supply strengthening at participating health facilities |
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実験的：Enhanced Strategies
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Core Strategies components plus CHW and clinician champions coaching and motivation with support from practice facilitators |
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 |
|---|---|---|
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Implementation: Penetration
時間枠：Months 0-18
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Proportion of adults 40 years and older with hypertension who receive at least 1 telehealth hypertension visit |
Months 0-18
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Effectiveness: Population-level hypertension control
時間枠：Months 12-18
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Proportion of adults 40 years and older with hypertension who have controlled blood pressure (<140/90 mmHg) at last measure during months 12-18 |
Months 12-18
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協力者と研究者
協力者
捜査官
- 主任研究者：Matt Hickey, MD、University of California, San Francisco
- 主任研究者：James Ayieko, MBChB, PhD, MPH、Kenya Medical Research Institute
出版物と役立つリンク
一般刊行物
- Hickey MD, Owaraganise A, Ogachi S, Sunday H, Aoko C, Sang N, Agengo G, Kabami J, Kakande E, Mugoma EW, Schwab J, Sutter N, Black D, Muiru A, Chamie G, Petersen ML, Balzer LB, Bukusi EA, Havlir DV, Kamya MR, Ayieko J. A prospective cohort study of the SEARCH integrated HIV/hypertension community health worker-led intervention in rural Kenya and Uganda. J Int AIDS Soc. 2025 Jul;28 Suppl 3(Suppl 3):e26500. doi: 10.1002/jia2.26500.
- Hickey MD, Ayieko J, Kabami J, Owaraganise A, Kakande E, Ogachi S, Aoko CI, Wafula EM, Sang N, Sunday H, Revill P, Bansi-Matharu L, Shade SB, Chamie G, Balzer LB, Petersen ML, Havlir DV, Kamya MR, Phillips AN. Cost-effectiveness of leveraging existing HIV primary health systems and community health workers for hypertension screening and treatment in Africa: An individual-based modeling study. PLoS Med. 2025 Jan 24;22(1):e1004531. doi: 10.1371/journal.pmed.1004531. eCollection 2025 Jan.
- Hickey MD, Owaraganise A, Ogachi S, Sang N, Wafula EM, Kabami J, Sutter N, Temple J, Muiru A, Chamie G, Kakande E, Petersen ML, Balzer LB, Havlir DV, Kamya MR, Ayieko J. Community health worker-facilitated telehealth for moderate-severe hypertension care in Kenya and Uganda: A randomized controlled trial. PLoS Med. 2025 Jun 5;22(6):e1004632. doi: 10.1371/journal.pmed.1004632. eCollection 2025 Jun.
- Hickey MD, Ayieko J, Owaraganise A, Sim N, Balzer LB, Kabami J, Atukunda M, Opel FJ, Wafula E, Nyabuti M, Brown L, Chamie G, Jain V, Peng J, Kwarisiima D, Camlin CS, Charlebois ED, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV. Effect of a patient-centered hypertension delivery strategy on all-cause mortality: Secondary analysis of SEARCH, a community-randomized trial in rural Kenya and Uganda. PLoS Med. 2021 Sep 20;18(9):e1003803. doi: 10.1371/journal.pmed.1003803. eCollection 2021 Sep.
研究記録日
主要日程の研究
研究開始 (推定)
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
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