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Completed

NCT Number: NCT07507461

Protocol for Integrating 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.

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Key information

Conditions

Soil Transmitted Helminth (STH) Infections Helminthiasis Infections Parasitic Diseases Schistosomiasis Schistosomiasis Infection Trematode Infections Vector Borne Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Based, no facility

Kakamega, Kenya

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All eligible community members, including school-age children (SAC; 5-14 years) and adults (15 years and above) receiving targeted treatment for SCH.
  • 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.
  • 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.

Treatment and study plan

Primary Healthcare-Integrated Service Delivery

Other
  • 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.

Standard Mass Drug Adminitsration service delivery

Other

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.

Primary outcomes

  1. 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.

    Time frame: 12 weeks after initiation of STH/SCH treatment integration into the primary healthcare system

    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.

  2. Mass drug administration coverage in the target population, comparing reported coverage and survey-based coverage in the intervention and control groups

    Time frame: From enrollment through the endline survey at 3 months after initiation of MDA

    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.

  3. Implementation cost of integrating STH/SCH treatment into the primary healthcare system, measured as cost per treated individual in the intervention and control groups

    Time frame: 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

    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.

Secondary outcomes

  1. 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.

    Time frame: From enrollment through the endline survey at 3 months after initiation of MDA.

    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.

  2. Proportion of participants who were never treated in the intervention and control groups

    Time frame: From enrollment through the endline survey at 3 months after initiation of MDA

    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.

Sponsors and collaborators

Lead sponsor

Amref Health Africa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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