ClinicalTrials.gg
Not yet recruitingNCT07927114COMPASSUpdated Nov 9, 2026

A Study to Evaluate the Best Ways to Implement a Community Health Worker-supported Telehealth Program for Managing High Blood Pressure in Kenya

An interventional study of Core Strategies and Enhanced Strategies in Hypertension (HTN), Telehealth and Community Health Workers, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in Kenya. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
3,200
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hypertension (HTN)
  • Telehealth
  • Community Health Workers

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Keywords

  • Hypertension
  • Telehealth
  • Kenya
  • Adults
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 3,200 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,200 participants (estimated)

Study arms

  • Active comparator
    Core Strategies

    Other: Core Strategies

  • Experimental
    Enhanced Strategies

    Other: Enhanced Strategies

Interventions

  • OtherCore Strategies

    CHWs and clinicians receive case-based training, MoH leadership supervision, implementation blueprints with medication supply strengthening at participating health facilities

  • OtherEnhanced Strategies

    Core Strategies components plus CHW and clinician champions coaching and motivation with support from practice facilitators

06

What researchers measure

Primary outcomes

  1. Implementation: Penetration

    Proportion of adults 40 years and older with hypertension who receive at least 1 telehealth hypertension visit

    Time frame: Months 0-18

  2. Effectiveness: Population-level hypertension control

    Proportion of adults 40 years and older with hypertension who have controlled blood pressure (\<140/90 mmHg) at last measure during months 12-18

    Time frame: Months 12-18

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 40622370 ↗
  • 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. PubMed 39854581 ↗
  • 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. PubMed 40472026 ↗
  • 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. PubMed 34543267 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927114
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jun 1, 2027 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Nov 9, 2026

Study contacts

Douglas Black
Contact
douglas.black@ucsf.edu
415-806-3016
Matt Hickey, MD
principal investigator · University of California, San Francisco
James Ayieko, MBChB, PhD, MPH
principal investigator · Kenya Medical Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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