Soil Transmitted Helminth (STH) InfectionsNCT07507461
Protocol for Integrating Mass Drug Administration Into Primary Health Care in Western Kenya
A study testing Primary Healthcare-Integrated Service Delivery and Standard Mass Drug Adminitsration service delivery in people with Soil Transmitted Helminth (STH) Infections and Schistosomiasis Infection, run by Amref Health Africa at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soil Transmitted Helminth (STH) Infections, Schistosomiasis Infection
- What is being tested?
- Primary Healthcare-Integrated Service Delivery and Standard Mass Drug Adminitsration service delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,229 participants
- Where
- 1 siteKenya
- Study dates
- 22 May 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Being tested
- Primary Healthcare-Integrated Service Delivery, Standard Mass Drug Adminitsration service delivery
- Keywords
- Primary Healthcare, Integration, Schistosomiasis, Soil-Transmitted Helminth (STH) Infections
- Medical subject headings
- Infections, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Healthcare-Integrated Service DeliveryOther
- 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 deliveryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard Mass Drug Adminitsration service delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: From enrollment through the endline survey at 3 months after initiation of MDA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start22 May 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soil Transmitted Helminth (STH) InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled trial, with a controlled before-and-after structure
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amref Health Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507461
- Sponsor's protocol ID
- B1422192025
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muchangi JM, Omondi W, Ndirangu M, Karutu C, Chami I, Wangalwa G, Juma C, Ofire M, Ofwete R, Kithuki K, Mwamburi M, Kamau S, Kariuki L, Kibati P, Athanasio J, Njuhi G, Opanga Y, Musombi E. Feasibility of mainstreaming schistosomiasis and soil transmitted helminthiasis mass drug administration into primary healthcare: a baseline survey for a community case study in Western Kenya. BMC Health Serv Res. 2026 May 16;26(1):963. doi: 10.1186/s12913-026-14699-5.
PubMed 42143304
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Community Case Study on Integrating Schistosomiasis and Soil-Transmitted Helminthiasis Mass Drug Administration Into Primary Health Care in Western Kenya
- ClinicalTrials.gov ID
- NCT07507461
- Acronym / sponsor ID
- B1422192025
- Keywords
- Primary Healthcare, Integration, Schistosomiasis, Soil-Transmitted Helminth (STH) Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,229 participants (actual)
- Lead sponsor
- Amref Health AfricaUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized controlled trial, with a controlled before-and-after structure
| Arm | Type | Receives |
|---|---|---|
| PHC Integrated SCH/STH treatment | Experimental | Other: Primary Healthcare-Integrated Service DeliveryThe 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 |
| Standard MDA treatment | Active comparator | Other: Standard Mass Drug Adminitsration service deliveryThe control group will comprise communities and health facilities operating under the conventional MDA model, where SCH/STH treatment is delivered independently of PHC services. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | PHC Integrated SCH/STH treatment |
| Standard Mass Drug Adminitsration service deliveryCampaign-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. | Other | Standard MDA treatment |
Primary outcome
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.
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.
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.
2 secondary outcomes
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Derived from this study: PubMed 42143304Muchangi JM, Omondi W, Ndirangu M, Karutu C, Chami I, Wangalwa G, Juma C, Ofire M, Ofwete R, Kithuki K, Mwamburi M, Kamau S, Kariuki L, Kibati P, Athanasio J, Njuhi G, Opanga Y, Musombi E. Feasibility of mainstreaming schistosomiasis and soil transmitted helminthiasis mass drug administration into primary healthcare: a baseline survey for a community case study in Western Kenya. BMC Health Serv Res. 2026 May 16;26(1):963. doi: 10.1186/s12913-026-14699-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Healthcare-Integrated Service Delivery and Standard Mass Drug Adminitsration service delivery in people with Soil Transmitted Helminth (STH) Infections and Schistosomiasis Infection, run by Amref Health Africa at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07507461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.