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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Douglas Black
- Telefonnummer: 415-806-3016
- E-post: douglas.black@ucsf.edu
Studiesteder
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Mbita, Kenya
- GPRT
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Ta kontakt med:
- Janice Litunya, MBChB
- Telefonnummer: +254-710-710593
- E-post: litunyajaniceo@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Eksperimentell: Enhanced Strategies
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Core Strategies components plus CHW and clinician champions coaching and motivation with support from practice facilitators |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Implementation: Penetration
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Matt Hickey, MD, University of California, San Francisco
- Hovedetterforsker: James Ayieko, MBChB, PhD, MPH, Kenya Medical Research Institute
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- COMPASS HTN
- R01HL180265 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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