An interventional study of Primary Healthcare-Integrated Service Delivery and Standard Mass Drug Adminitsration service delivery in Soil Transmitted Helminth (STH) Infections and Schistosomiasis Infection, sponsored by Amref Health Africa. Completed at 1 site in Kenya. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Amref Health Africa · Not applicable, Interventional, and Health services research
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:
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:
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
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 1,229 is above the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Amref Health Africa is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Schistosomiasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria
Exclusion Criteria Residents in wards outside the 122 non-Interruption of Transmission (non-IoT) wards.
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
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
* 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.
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.
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: From enrollment through the endline survey at 3 months after initiation of MDA
Plan to share: No
Ran from May 2025 to primary completion in Oct 2025, 4 months.
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Amref Health Africa