Recruitment is done at the Household level in selected communities
Ondo, Ondo, Taraba and Akwa Ibom, Nigeria
Location status: Recruiting
NCT Number: NCT07707817
Neglected Tropical Diseases (NTDs) are among the most common groups of diseases affecting over one billion people globally and are disproportionately concentrated in remote, underserved, and marginalized communities. Efforts toward NTD elimination have largely relied on preventive chemotherapy (PC), large-scale distribution of free, safe, and effective medicines to at-risk populations. One major challenge threatening elimination efforts is the poor participation of mobile and migrant populations (MMPs) in treatment programs. Despite this gap, few studies have explored strategies to improve access among these underserved populations.
This study aims to determine the burden of NTDs among MMPs and explore strategies for expanding access to preventive chemotherapy through social and occupational networks using community mapping and participatory action research approaches in Nigeria.
This project is a multi-site implementation research study involving 15 communities across three Nigerian states-Taraba, Akwa Ibom, and Ondo-representing pastoralist, fishing, and agrarian settings, respectively. The study comprises four phases. The first two formative phases will assess the baseline burden of NTDs and coverage of preventive chemotherapy interventions using community surveys, parasitological and serological assessments, mapping, and participatory workshops to identify migration patterns, anchor points, and social and occupational networks that could support expansion of PC. The third phase will use participatory approaches to co-construct context-specific strategies for expanding access to preventive chemotherapy among MMPs. In the fourth phase, the co-developed strategies will be implemented and evaluated for impact using established implementation research frameworks and mixed methods approaches.
Through this project, investigators will develop and evaluate a novel strategy for expanding access to PC among MMPs. The study will generate evidence on the feasibility, acceptability, reach, and sustainability of the proposed approach and is expected to inform adaptable implementation models for inclusive NTD programming in Nigeria and similar endemic settings.
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Request Info5 year and older
All sexes
Interventional
Not applicable
Ondo, Ondo, Taraba and Akwa Ibom, Nigeria
Location status: Recruiting
Neglected tropical diseases (NTDs) are among the most common groups of diseases globally, affecting more than one billion people and disproportionately burdening remote, underserved, and marginalized populations. The World Health Organization (WHO) broadly classifies most NTDs into two categories based on their recommended management approaches. Case-management NTDs-including Buruli ulcer, human African trypanosomiasis, rabies, Guinea worm disease, lymphoedema, leprosy, trichiasis, leishmaniasis, yaws, dengue, and mycetoma-require individualized diagnosis and treatment because of management complexity or the absence of effective large-scale diagnostic and therapeutic tools. In contrast, preventive chemotherapy NTDs (PC-NTDs), such as onchocerciasis, schistosomiasis, lymphatic filariasis, trachoma, and soil-transmitted helminthiasis, are primarily controlled through mass drug administration (MDA) delivered to at-risk populations to reduce morbidity and interrupt transmission. Other NTDs that do not neatly fit within these categories, such as rabies, snakebite envenoming, and dengue, require alternative prevention and control approaches. In many endemic countries, PC-NTDs constitute the largest proportion of the NTD burden and therefore have well-established control programs.
Over the last decade, NTDs have increasingly gained recognition as a major global health priority, culminating in the WHO NTD Road Map 2021-2030, which outlines ambitious targets for the control, elimination, or eradication of all NTDs in alignment with the Sustainable Development Goals. Despite these commitments, progress toward achieving the 2030 elimination targets for several PC-NTDs remains insufficient. In the African Region, where more than 40% of the global NTD burden is concentrated, only 19 of 54 countries had eliminated at least one NTD as of 2025. Persistent gaps in intervention coverage among vulnerable and underserved populations continue to threaten progress toward NTD elimination goals. Several programmatic bottlenecks have been identified, including but not limited to poor community awareness, perceived severity of the disease, perceived benefits of interventions, inadequate human and financial resources for programming, conflict and insecurity, political instability, and increasing migration and population mobility. While many of these barriers have received considerable global attention, migration and population mobility are increasingly emerging as critical yet understudied challenges. Population movement may occur because of conflict, insecurity, environmental pressures, seasonal labor, or other livelihood-related factors (trade, pastoralism, fishing, leisure, schooling), all of which may disrupt access to routine public health interventions. However, the specific implications of migration for MDA delivery, treatment continuity, and coverage remain poorly understood. Similarly, evidence-based strategies for optimizing PC-NTD programs among highly mobile and migrant populations remain limited.
Nigeria, the most populous country in sub-Saharan Africa, accounts for approximately one-quarter of the continent's NTD burden and has yet to eliminate any major NTD. For more than a decade, our team has collaborated with the Nigerian government and implementing partners to support NTD elimination efforts across the country. Although substantial progress has been made in reducing disease prevalence, improving morbidity management, and responding to outbreaks, migration continues to pose a major challenge to achieving optimal treatment coverage and has received limited attention within existing elimination strategies. Population movement within Nigeria and across neighboring borders are often driven by seasonal climatic patterns, insecurity and economic opportunities, and is facilitated by extensive river systems, trade corridors, grazing routes, and arable lands that sustain economic activities. These populations, herein referred to as mobile and migrant populations (MMPs), are frequently absent during MDA campaigns. Consequently, they often experience non-treatment, limited awareness of MDA activities, limited engagement with health-workers, and increasing community fatigue. Collectively, these dynamics may contribute to treatment refusals, sustain disease transmission, and slow progress toward elimination goals. The investigators therefore posit the need to improve MDA access, reach, and coverage among MMPs through approaches that strengthen involvement, trust, ownership, and the perceived value of MDA among MMPs that have historically been underrepresented in routine health programs.
This study aims to develop and evaluate a novel delivery model that utilizes community mapping and participatory research approaches to strengthen access to MDA among MMPs. The process will begin by generating a detailed understanding of migration realities, including migratory routes, movement timing, seasonal patterns, and key drivers of mobility, to identify where, when, and how MMPs move across different settings. The study will also explore the social and occupational networks that exist along these migratory pathways and assess how these networks can be strategically leveraged to expand MDA access and delivery. Ultimately, the overarching aim of the study is to evaluate whether this co-constructed delivery model can improve access, reach, and coverage of MDA among MMPs in Nigeria compared with standard delivery approaches. Specifically, the study will explore migratory routes, movement patterns, and drivers influencing participation in MDA; identify the social and occupational structures that shape mobility and access to healthcare; and examine how these existing networks can be strategically leveraged to improve MDA delivery, reporting, and community engagement. In addition, the study will assess the livelihood-linked incentives and complementary services prioritized by MMPs and evaluate how integrating these preferences into intervention design may strengthen demand for and participation in preventive chemotherapy programs. Finally, the study will examine the contextual, behavioral, and structural factors influencing implementation, while exploring how participatory processes foster trust, ownership, inclusivity, feasibility, sustainability, and scalability of the proposed delivery model across diverse migratory settings in Nigeria.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants will be eligible for inclusion if they:
Exclusion criteria
Participants will be excluded if they:
Unlike routine MAM, which primarily relies on fixed household-based distribution strategies, the modified MAM will be developed through community-based participatory research (CBPR) with MMPs and other stakeholders to better accommodate their mobility patterns and livelihood activities. The intervention will include: (i) selection of convenient and accessible community anchor sites for medicine distribution; (ii) flexible timing of medicine distribution to coincide with periods when MMPs are available; (iii) integration of community-prioritized livelihood additionalities to enhance participation, engagement, and demand for treatment; and (iv) implementation of an electronic system for the collection, documentation, and transmission. The medicines administered, dosage schedules, and eligibility criteria will remain consistent with World Health Organization (WHO) recommendations.
Other names: Mass Administration of Medicine, Mass Drug Administration, Preventive Chemotherapy
Medicines administered to prevent and treat soil-transmitted helminthiasis
Other names: Mebendazole
Medicines administered to prevent and treat schistosomiasis
Medicines administered to prevent and treat onchocerciasis
Medicines administered to prevent and treat lymphatic filariasis
Time frame: Baseline ( to estimate reach in the previous MAM) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Reach is defined as the proportion of eligible MMPs who were offered preventive chemotherapy during the modified MAM campaign. Reach will be assessed using coverage evaluation surveys and reported as the percentage of eligible participants who answered "Yes" to receiving an offer of treatment.
Time frame: Baseline (previous MAM campaign) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Coverage is defined as the proportion of eligible MMPs who received and swallowed the offered preventive chemotherapy during the modified MAM campaign. Coverage will be assessed using coverage evaluation surveys and reported as the percentage of eligible participants who answered "Yes."
Time frame: Baseline (previous MAM campaign) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Compliance is defined as the proportion of MMPs who swallowed all preventive chemotherapy medicines after receiving them during the modified MAM campaign. Compliance will be assessed using coverage evaluation surveys and reported as the percentage of participants providing affirmative responses.
Time frame: Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Acceptability is defined as the perception among MMPs that the modified MAM strategy is satisfactory, agreeable, and acceptable. Acceptability will be assessed using binary (Yes/No) questions covering the delivery location, timing, and personnel involved in medicine distribution and reported as the percentage of affirmative responses.
Time frame: Baseline (prior to implementation of the modified MAM strategy; within the fourth month of the study).
Prevalence will be measured as the proportion of sampled MMP children testing positive for at least one preventive chemotherapy-targeted neglected tropical disease (schistosomiasis, soil-transmitted helminthiasis, lymphatic filariasis, or onchocerciasis) using WHO-recommended diagnostic methods. Disease-specific prevalence will also be reported.
Time frame: Immediately following validation of the modified MAM strategy during the final participatory planning meeting (within the fourth month of the study).
Adoption is defined as the initial decision or action to employ an innovation or implementation strategy. Adoption of the modified MAM strategy will be assessed as the proportion of planned anchor sites that agree to implement the co-designed modified MAM strategy following the participatory planning process. Adoption will be measured using structured interviews with implementers and reported as the percentage of planned anchor sites providing an affirmative ("Yes") response.
Time frame: Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Penetration is defined as the extent to which an implementation strategy becomes integrated within the intended service setting. Penetration will be measured as the proportion of planned anchor sites that successfully implement the modified MAM strategy during the intervention period. Data will be collected through monitoring visits and structured interviews and reported as the percentage of planned anchor sites implementing the strategy.
Time frame: Throughout implementation of the modified MAM campaign and immediately after campaign completion (up to 4 weeks after intervention initiation).
Implementation fidelity is defined as the degree to which the modified MAM strategy is implemented according to the study protocol. Fidelity will be assessed using structured monitoring visits and implementation checklists evaluating adherence to agreed delivery locations, delivery timing, selected personnel, treatment documentation using village registers, and transmission of treatment reports using mobile phones. Results will be reported as the percentage of planned implementation components delivered as intended.
Time frame: Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Appropriateness is defined as the perceived fit, relevance, or compatibility of an implementation strategy for a particular setting or target population. Appropriateness of the modified MAM strategy will be assessed among mobile and migrant populations (MMPs) and community drug distributors using a study-specific binary (Yes/No) questionnaire covering delivery locations, timing, personnel, treatment documentation, and reporting procedures. Results will be reported as the percentage of respondents providing affirmative ("Yes") responses.
Time frame: Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Feasibility is defined as the extent to which an implementation strategy can be successfully used or carried out within a particular setting. Feasibility of the modified MAM strategy will be assessed among MMPs and community drug distributors using a study-specific binary (Yes/No) questionnaire. Results will be reported as the percentage of respondents indicating that participation in or implementation of the modified MAM strategy was easy.
Time frame: Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
Sustainability is defined as the extent to which an implementation strategy can be maintained within routine programme operations over time. Sustainability of the modified MAM strategy will be assessed among implementers using a study-specific binary (Yes/No) questionnaire. Results will be reported as the percentage of implementers indicating that they could continue implementing the modified MAM strategy without additional monitoring or external support.
Time frame: From intervention initiation through completion of the modified MAM campaign (approximately 4 weeks).
Implementation cost is defined as the operational resources required to implement the modified MAM strategy. Costs will be estimated using programme expenditure records, resource utilization data, and structured interviews with implementers. Outcomes will include the total implementation cost, cost by implementation activity, and the average implementation cost per anchor site and per participant treated.
Time frame: Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).
Spatial migration patterns refer to the movement pathways of MMPs, including places of origin, transit points, temporary settlements, and destinations during a typical annual migration cycle. Spatial migration patterns will be identified through participatory mapping workshops.
Time frame: Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).
Temporal migration patterns describe the timing, frequency, duration, and seasonality of migration among MMPs during a typical annual cycle. Temporal migration patterns will be identified through participatory mapping workshops.
Time frame: Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).
Migration drivers are the social, economic, environmental, occupational, cultural, and security-related factors influencing migration decisions and mobility patterns among MMPs. Migration drivers will be identified through participatory mapping workshops.
Time frame: Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).
Community priorities include contextual factors such as preferred delivery locations, timing, trusted personnel, communication channels, and community networks that can be leveraged to align the modified MAM strategy with the lifestyle and mobility patterns of MMPs. Community priorities will be identified through participatory mapping workshops.
Time frame: Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).
Livelihood additionalities are complementary livelihood support interventions identified by MMPs that could be integrated with the modified MAM strategy to improve participation, engagement, and demand for treatment. Examples include agricultural support, animal health services, financial empowerment, educational support, market access, and other community-prioritized interventions. Livelihood additionalities will be identified through participatory mapping workshops.
Contact information is provided by the study sponsor or research team.
Uwemedimo Friday Ekpo
Other
A Community Mapping and Participatory Research Protocol for Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations Through Social and Occupational Networks in Nigeria: MISSION Nigeria
Acronym: MISSION
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