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Not yet recruitingNCT07927114ClinicalTrials.gov record

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

Hypertension (HTN) · Telehealth · Community Health Workers

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
40 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
3200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
Core Strategies

Not reported in this registry record.

Other: Core Strategies

Enhanced Strategies

Not reported in this registry record.

Other: Enhanced Strategies

Core Strategies OTHER

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

Enhanced Strategies OTHER

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Implementation: Penetration

Time frame: Months 0-18

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

Effectiveness: Population-level hypertension control

Time frame: Months 12-18

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

GPRTMbita, KenyaStatus unknown

Study team and timeline

Lead sponsor
University of California, San Francisco
Study start
Jun 1, 2027 Estimated
Primary completion
Jun 1, 2029 Estimated
Study completion
Jun 1, 2029 Estimated
First posted
Nov 9, 2026 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

Official study title

Community-based Implementation of Hypertension Screening and Telehealth Systems in Kenya

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026