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Protocol for Integrating Mass Drug Administration Into Primary Health Care in Western Kenya

NCT07507461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1229

Last updated 2026-04-02

No results posted yet for this study

Summary

This study aims to determine whether distributing deworming drugs through routine healthcare services at the first point of contact in the health system is an effective way to prevent and treat worm infections in Western Kenya. This will be compared to the current campaign-based method that operates outside the health system.

The main questions it aims to answer are:

* Is the alternative method suitable and achievable in the targeted area?
* What percentage of the population does this method cover? How does it compare with the current method?
* How cost-effective is this alternative method?

Researchers will compare outcomes in wards where the integrated method of drug administration is implemented (intervention arm) to wards where the standard campaign-based method is continued (control arm) to answer these questions.

Participants from both arms of the study will:

* Community members will respond to survey questions on their experience and access levels to deworming drugs. Some will also participate in Focus Group Discussions.
* Health facility heads will be interviewed to assess the health facility and collect cost data.
* Key stakeholders within the county administration will be engaged in key informant interviews.
* Community Health Promoters will participate in Focus Group Discussions.

Conditions

  • Soil Transmitted Helminth (STH) Infections
  • Schistosomiasis Infection

Interventions

OTHER

Primary Healthcare-Integrated Service Delivery

* Service Delivery: Embedding Mass Drug Administration (MDA) into routine service delivery channels within PHC platforms, including health facilities and schools. * Health Workforce: Training PHC staff in STH/SCH case management, adverse event reporting, and integration. * Community Engagement: Through the use of the electronic Community Health Information System (eCHIS), Community Health Promoters (CHPs) support treatment delivery and conduct household and school-based follow-ups. * Sustainability: Transition from donor-dependent MDA campaigns to county-led, sustainably budgeted deworming services, fully embedded within routine PHC planning. * Integration of NTD indicators into national data systems such as DHIS2 and eCHIS.

OTHER

Standard Mass Drug Adminitsration service delivery

Campaign-based MDA, which is primarily donor-funded, implemented through community drug distributors (CDDs), and conducted separately from routine health services. Control sites will be selected from among the 122 Non-Interruption of Transmission (Non-IoT) wards that follow this conventional model.

Sponsors & Collaborators

  • Amref Health Africa

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507461 on ClinicalTrials.gov