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

NCT07507461 | Completed

• 1 other identifier: B1422192025
• Study Type: interventional
• Target: 1,229
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Healthcare; Integration; Schistosomiasis; Soil-Transmitted Helminth (STH) Infections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

  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

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

Study Arms (2)

PHC Integrated SCH/STH treatment

EXPERIMENTAL

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

Standard MDA treatment

ACTIVE COMPARATOR

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

Interventions

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.

PHC Integrated SCH/STH treatment

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.

Standard MDA treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Amref Health Africa: lead

Study Sites (1)

Community Based, no facility

Kakamega, Kenya

Location

MeSH Terms

Conditions

Infections; Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized controlled trial, with a controlled before-and-after structure

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: April 2, 2026
• Study Start: May 22, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)