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

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.

Study Overview

• Status: Completed
• Conditions: Schistosomiasis Infection; Soil Transmitted Helminth (STH) Infections
• Intervention / Treatment: Other: Primary Healthcare-Integrated Service Delivery; Other: Standard Mass Drug Adminitsration service delivery

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

• Study Type: Interventional
• Enrollment (Actual): 1229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kakamega, Kenya
    • Community Based, no facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. All eligible community members, including school-age children (SAC; 5-14 years) and adults (15 years and above) receiving targeted treatment for SCH.
2. Preschool-age children (PRESAC; 1-4 years), school-age children (SAC; 5-14 years), and adults (15 years and above) receiving targeted treatment for STH.
3. Must be residents of the target counties (Vihiga, Kakamega, Bungoma, and Trans-Nzoia).

Exclusion Criteria Residents in wards outside the 122 non-Interruption of Transmission (non-IoT) wards.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PHC Integrated SCH/STH treatment; The intervention group includes communities and health facilities earmarked for future integration of STH/SCH treatment into primary health care (PHC). They are also drawn from the 122 non-IOT wards, enabling comparability with control areas.; 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 service 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: Transitioning 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 like DHIS2 and eCHIS	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.
Active Comparator: Standard MDA treatment; The control group will comprise communities and health facilities operating under the conventional MDA model, where SCH/STH treatment is delivered independently of PHC services.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of primary healthcare facilities achieving high feasibility of integrating STH/SCH treatment into the primary healthcare system, as measured by a multi-domain feasibility questionnaire with a maximum score of 10.	Feasibility of integrating STH/SCH treatment into the primary healthcare system will be assessed using a structured multi-domain feasibility questionnaire administered to facility managers and key health workers. The questionnaire covers implementation experiences, perceived changes, contextual influences, service provision, integrated treatment services, CHP training and refresher trainings, stock-outs, outreach treatments, data reporting, and related barriers and facilitators, reflecting the qualitative and quantitative domains analyzed in the study. Scores of 0-4 will be classified as low feasibility, 5-6 as moderate, and 7-10 as high feasibility.	12 weeks after initiation of STH/SCH treatment integration into the primary healthcare system
Mass drug administration coverage in the target population, comparing reported coverage and survey-based coverage in the intervention and control groups	MDA coverage will be assessed as the percentage of the target population that received treatment, using both facility-reported coverage data and survey-based coverage obtained from household survey data. Coverage will be reported separately for the intervention and control groups, and the difference between reported and survey-based coverage will be compared.	From enrollment through the endline survey at 3 months after initiation of MDA
Implementation cost of integrating STH/SCH treatment into the primary healthcare system, measured as cost per treated individual in the intervention and control groups	The implementation cost of integrating STH/SCH treatment into the primary healthcare system will be estimated from a health-system/program perspective, using a bottom-up micro-costing approach based on locally available market prices, government wage structures, and international reference prices. Costs will include personnel time, drugs, supplies, transport, supervision, training, and other program-specific resources associated with routine PHC-integrated delivery and 5-day campaign-based de-worming. Total costs will be converted to 2025 USD and reported as the mean cost per treated individual (and per primary healthcare facility, where applicable) over the implementation period. These cost estimates will be combined with effectiveness data on infection cases averted to calculate the incremental cost-effectiveness ratio (ICER; cost per infection case averted) for the PHC-integrated model compared with the campaign-based model.	From intervention implementation through the endline assessment at 3 months after initiation of STH/SCH treatment integration, with 5-year projected costs and effects used for the cost-effectiveness analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who complied who actually swallowed the de-worming tablets among those who were offered them during the study period in the intervention and control groups.	Adherence to MDA will be assessed as the proportion of participants who completed actually ingested the treatment, based on self-reported or caregiver-reported information from the household survey. The outcome will be reported as the percentage of participants who complied with treatment in each study arm.	From enrollment through the endline survey at 3 months after initiation of MDA.
Proportion of participants who were never treated in the intervention and control groups	This will be defined as participants who were never reached with SCH/STH treatment. This will be assessed using household survey data and reported as the percentage of participants who did not receive treatment in each study arm. The questionnaire will capture the the cited reasons for non-treatment and determine the frequencies.	From enrollment through the endline survey at 3 months after initiation of MDA

Collaborators and Investigators

• Sponsor: Amref Health Africa

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Schistosomiasis; Integration; Primary Healthcare; Soil-Transmitted Helminth (STH) Infections
• Additional Relevant MeSH Terms: Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Trematode Infections; Infections; Schistosomiasis
• Other Study ID Numbers: B1422192025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No