NCT07507461

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

Protocol for a Community Case Study on Integrating Schistosomiasis and Soil-Transmitted Helminthiasis Mass Drug Administration Into Primary Health Care in Western Kenya

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,229 (actual)
• Sponsor: Amref Health Africa · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a quasi-experimental study assessing the integration of deworming services for soil-transmitted helminths (STH) and schistosomiasis (SCH) into routine primary health care (PHC) systems across four counties in Western Kenya. It evaluates Kenya's readiness to transition from periodic mass drug administration (MDA) campaigns to a sustainable, facility- and community-based delivery model aligned with Universal Health Coverage (UHC) goals. The study design is a non-randomized, controlled before-and-after study using a mixed-methods approach. Data will be collected from households, health facilities, focus group discussions (FGDs), and key informant interviews (KIIs). The analysis focuses on five domains of integration: service delivery, health workforce, community engagement, health information systems, and sustainability. The primary objective is to compare pre-intervention (baseline) and post-intervention (endline) data over a three-month period to evaluate treatment coverage of SCH/STH in intervention (integrated into PHC) versus non-integrated (MDA campaign approach) sites. The controlled before-and-after design was chosen to assess the impact of integrating SCH/STH treatment into PHC while accounting for external factors that may influence coverage rates and disease prevalence. Randomization was not applied, as site selection was based on programmatic feasibility and the capacity of local health systems

Conditions

• Soil Transmitted Helminth (STH) Infections
• Schistosomiasis Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-22
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Kenya