Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations

NCT07707817 | Recruiting

• 2 other identifiers: IRB/26/017NTDSC 291F
• Study Type: interventional
• Target: 5,760
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Onchocerciasis (River Blindness); Schistosomiasis; Soil Transmitted Helminth (STH) Infections; Lymphatic Filariasis

Keywords

Neglected Tropical Diseases; Mobile and Migrant populations; Participatory Research; Implementation Science; Nigeria; Mass Drug Administration; Mass Administration of Medicines

Outcome Measures

Primary Outcomes (12)

• Reach percentage measured as the proportion of eligible mobile and migrant populations (MMPs) offered preventive chemotherapy during the modified mass administration of medicines (MAM) campaign

  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.

  Baseline ( to estimate reach in the previous MAM) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Coverage percentage measured as the proportion of eligible MMPs who swallowed preventive chemotherapy during the modified MAM campaign

  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."

  Baseline (previous MAM campaign) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Compliance percentage measured as the proportion of MMPs who swallowed all medicines received during the modified MAM campaign

  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.

  Baseline (previous MAM campaign) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Acceptability rate (%) of the modified MAM strategy among mobile and migrant populations measured using a study-specific binary questionnaire informed by Proctor's Implementation Outcomes Framework

  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.

  Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Prevalence of preventive chemotherapy-targeted neglected tropical diseases among mobile and migrant population children

  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.

  Baseline (prior to implementation of the modified MAM strategy; within the fourth month of the study).

• Adoption rate (%) measured as the proportion of planned anchor sites intending to implement the modified mass administration of medicines (MAM) strategy

  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.

  Immediately following validation of the modified MAM strategy during the final participatory planning meeting (within the fourth month of the study).

• Penetration rate (%) measured as the proportion of planned anchor sites implementing the modified mass administration of medicines (MAM) strategy

  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.

  Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Implementation fidelity (%) measured as adherence to the planned components of the modified mass administration of medicines (MAM) strategy

  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.

  Throughout implementation of the modified MAM campaign and immediately after campaign completion (up to 4 weeks after intervention initiation).

• Appropriateness rate (%) of the modified mass administration of medicines (MAM) strategy among mobile and migrant populations and community drug distributors measured using a study-specific binary questionnaire informed by Proctor's Implementation Outcom

  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.

  Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Feasibility rate (%) of the modified mass administration of medicines (MAM) strategy among mobile and migrant populations and community drug distributors measured using a a binary questionnaire informed by Proctor's Implementation Outcomes Framework

  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.

  Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Sustainability rate (%) measured as the proportion of implementers able to continue the modified mass administration of medicines (MAM) strategy without additional monitoring or external support

  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.

  Immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).

• Implementation cost of the modified mass administration of medicines (MAM) strategy measured using programme expenditure and resource utilization records

  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.

  From intervention initiation through completion of the modified MAM campaign (approximately 4 weeks).

Secondary Outcomes (5)

• Spatial migration patterns of mobile and migrant populations identified through participatory mapping

  Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).

• Temporal migration patterns of mobile and migrant populations identified through participatory mapping

  Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).

• Migration drivers identified among mobile and migrant populations through participatory assessment

  Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).

• Community-defined implementation priorities for the modified MAM strategy

  Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).

• Community-prioritized livelihood support interventions to enhance participation in the modified MAM strategy

  Baseline (during participatory workshops conducted prior to implementation of the modified MAM strategy; within the fourth month of the study).

Study Arms (1)

Mobile and Migrant Populations

OTHER

Mobile and migrant populations in our context refer to individuals or groups who are frequently absent during mass drug administration (MDA) campaigns due to one or more factors, including conflict and insecurity, environmental pressures, seasonal labor migration, or livelihood-related activities such as trade, pastoralism, fishing, leisure, schooling, and other forms of mobility.

Other: Modified Mass Administration of Medicines Strategy; Drug: Albendazole 400 mg; Drug: Praziquantel 40 mg/kg; Drug: Ivermectin; Drug: Ivermectin + albendazole

Interventions

Modified Mass Administration of Medicines Strategy OTHER

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.

Also known as: Mass Administration of Medicine, Mass Drug Administration, Preventive Chemotherapy

Mobile and Migrant Populations

Albendazole 400 mg DRUG

Medicines administered to prevent and treat soil-transmitted helminthiasis

Also known as: Mebendazole

Mobile and Migrant Populations

Praziquantel 40 mg/kg DRUG

Medicines administered to prevent and treat schistosomiasis

Mobile and Migrant Populations

Ivermectin DRUG

Medicines administered to prevent and treat onchocerciasis

Mobile and Migrant Populations

Ivermectin + albendazole DRUG

Medicines administered to prevent and treat lymphatic filariasis

Mobile and Migrant Populations

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Are children aged 5-14 years or adult heads of households residing in households identified as belonging to mobile or migrant populations.
• Reside permanently or semi-permanently within the study communities
• Have missed one or more previous rounds of onchocerciasis and/or lymphatic filariasis MDA.
• Are willing to provide the required biological specimens and participate in interviews, surveys, and participatory workshops or discussions as required by the study protocol.
• Provide informed consent or assent with parental/guardian consent where applicable for minors.

You may not qualify if:

• Participants will be excluded if they:
• Are temporary visitors without meaningful residence in the study communities.
• Do not belong to the identified mobile or migrant populations targeted by the study.
• Are unable or unwilling to provide the required biological specimens or participate in study procedures.
• Decline informed consent or assent, or whose parent or guardian declines consent for participation.
• Are severely ill or have medical conditions that, in the opinion of study personnel, would make participation unsafe or inappropriate.

Sponsors & Collaborators

• Uwemedimo Friday Ekpo: lead
• Mission To Save The Helpless: collaborator
• Marian University: collaborator
• Hellen Keller International: collaborator
• Nigerian Federal Ministry of Health: collaborator

Study Sites (1)

Recruitment is done at the Household level in selected communities

Ondo, Ondo, Taraba and Akwa Ibom, Nigeria

RECRUITING

Related Publications (13)

• Schürmann, A., J. Kleemann, M. Teucher, C. Fürst, and C. Conrad. 2022. Migration in West Africa: a visual analysis of motivation, causes, and routes. Ecology and Society. 27(3):16. Available at https://ecologyandsociety.org/vol27/iss3/art16/

  BACKGROUND

• Mogaji H, Alexandra Alzate LY, Figueredo LA, Araujo Virgens JH, Aliaga MA, Argibay HD, Salles I, Pereira Moreira A, Lima E Silva TJ, Cristina Dos Santos S, Batista R, Cardoso E, Neves Santos EC, Leal Dos Santos E, Rodrigues Dos Santos E, da Mata Barreto T, Dos Santos Mattos TA, Nery N Jr, Cruz J, Carneiro I, Lustosa R, Dedavid Ferreira VC, Reis M, Ko AI, Costa F, Begon M, Khalil H. Co-production of informal settlement health: a community based participatory research program for building healthy communities in urban informal settlements of Salvador, Brazil. Front Public Health. 2026 Mar 10;14:1754353. doi: 10.3389/fpubh.2026.1754353. eCollection 2026.

  PMID: 41883820 BACKGROUND

• 36. RE-AIM Framework. Available at https://re-aim.org/

  BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.

  PMID: 20147663 BACKGROUND

• Sangare M, Coulibaly YI, Ravichandran P, Diabate AF, Duguay C, Vlassoff C, Kulkarni MA, Krentel A. Exploring the impact of mobile and migrant populations on mass drug administration coverage and effectiveness in Africa: A scoping review protocol. PLoS One. 2025 May 29;20(5):e0324949. doi: 10.1371/journal.pone.0324949. eCollection 2025.

  PMID: 40440352 BACKGROUND

• Sangare M, Diabate AF, Coulibaly YI, Tanapo D, Thera SO, Dolo H, Dicko I, Coulibaly O, Sall B, Traore F, Doumbia S, Kulkarni MA, Nutman TB, Krentel A. Understanding the barriers and facilitators related to never treatment during mass drug administration among mobile and migrant populations in Mali: a qualitative exploratory study. BMJ Glob Health. 2024 Oct 9;9(10):e015671. doi: 10.1136/bmjgh-2024-015671.

  PMID: 39384331 BACKGROUND

• 25. UN Migration. Climate change, disasters, insecurity, and displacement: The impact of flooding on youth marginalization and human mobility in Nigeria. Available at https://environmentalmigration.iom.int/blogs/climate-change-disasters-insecurity-and-displacement-impact-flooding-youth-marginalization-and-human-mobility-nigeria

  BACKGROUND

• Mogaji HO, Olamiju FO, Oyinlola F, Achu I, Adekunle ON, Udofia LE, Edelduok EG, Yaro CA, Oladipupo OO, Kehinde AY, Oyediran F, Aderogba M, Makau-Barasa LK, Ekpo UF. Prevalence, intensity and risk factors of soil-transmitted helminthiasis after five effective rounds of preventive chemotherapy across three implementation units in Ondo State, Nigeria. PLoS Negl Trop Dis. 2025 Jan 6;19(1):e0012533. doi: 10.1371/journal.pntd.0012533. eCollection 2025 Jan.

  PMID: 39761330 BACKGROUND

• Ekpo UF, Olamiju FO, Mogaji HO, Ovia SN, Oladipupo OO, Kehinde AY, Oyediran FO, Aderogba M, Makau-Barasa LK. Sensitivity of Three Impact Assessment Methodologies in Adjusting Preventive Chemotherapy Treatment Decisions for Schistosomiasis Elimination in Ondo State, Nigeria. Am J Trop Med Hyg. 2025 Feb 18;112(5):987-999. doi: 10.4269/ajtmh.24-0352. Print 2025 May 7.

  PMID: 39965211 BACKGROUND

• Mogaji HO, Okoh HI, Lawal AM, Ojo KH, Marcus AJ, Aaron NO, Adeleye DR, Olamiju FO, Ekpo UF. A Post-Lockdown Assessment of Albendazole Treatment Coverage in Mass Drug Administration Campaigns Implemented Before and During COVID-19 Pandemic in Ekiti, Southwest Nigeria. Int J Public Health. 2023 Feb 9;68:1605510. doi: 10.3389/ijph.2023.1605510. eCollection 2023.

  PMID: 36846154 BACKGROUND

• 3. World Health Organization. Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021-2030. Geneva. World Health Organization;2020

  BACKGROUND

• Hotez PJ, Asojo OA, Adesina AM. Nigeria: "Ground Zero" for the high prevalence neglected tropical diseases. PLoS Negl Trop Dis. 2012;6(7):e1600. doi: 10.1371/journal.pntd.0001600. Epub 2012 Jul 31. No abstract available.

  PMID: 22860138 BACKGROUND

Related Links

• RE-AIM Framework

MeSH Terms

Conditions

Onchocerciasis; Onchocerciasis, Ocular; Schistosomiasis; Infections; Elephantiasis, Filarial; Neglected Diseases

Interventions

Mass Drug Administration; Albendazole; Mebendazole; Praziquantel; Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Eye Infections, Parasitic; Vector Borne Diseases; Eye Infections; Eye Diseases; Trematode Infections; Mosquito-Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Disease Eradication; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines; Macrolides; Polyketides; Lactones

Study Officials

• Uwem Ekpo, PhD

  Akwa Ibom State University

  PRINCIPAL INVESTIGATOR

• Hammed Mogaji, PhD

  Marian University

  STUDY DIRECTOR

Central Study Contacts

Uwem Ekpo, PhD

CONTACT

+2348092024306; uwemekpo@aksu.edu.ng

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study will employ a single-arm interventional design in which all selected communities will receive the modified mass administration of medicines (MAM) strategy. All participants will receive the same WHO-recommended anthelminthic medicines and dosing schedules; the intervention differs from routine practice only in the delivery and implementation strategy. The effectiveness and feasibility of the modified MAM approach will be evaluated by comparing implementation and outcome measures collected before and after the intervention within the same study population.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) will be shared as they become available throughout the course of the project. The study protocol will be made publicly available following publication, while study instruments, de-identified datasets, metadata, and analysis scripts used for data management and statistical analyses will be shared at later stages during the lifetime of the project. All shared data will be de-identified in accordance with applicable ethical and data protection requirements. Data and associated materials will be deposited in appropriate open repositories and will remain accessible for an indefinite period to support transparency, reproducibility, and secondary analyses. Access to these resources will be unrestricted and available to all interested users.
• Access Criteria: Data and associated materials will be deposited in appropriate open repositories and will remain accessible for an indefinite period to support transparency, reproducibility, and secondary analyses. Access to these resources will be unrestricted and available to all interested users here at https://zenodo.org/records/20585239

Locations

NG (1)