Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorUwemedimo Friday Ekpo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Modified Mass Administration of Medicines Strategy

    Other intervention

    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.

  • Albendazole 400 mg

    Drug

    Medicines administered to prevent and treat soil-transmitted helminthiasis

  • Praziquantel 40 mg/kg

    Drug

    Medicines administered to prevent and treat schistosomiasis

  • Ivermectin

    Drug

    Medicines administered to prevent and treat onchocerciasis

  • Ivermectin + albendazole

    Drug

    Medicines administered to prevent and treat lymphatic filariasis

Treatment groups

5,760 Participants
are divided into 1 treatment group
Group A: Mobile and Migrant PopulationsOther 5 interventions

Trial outcomes

Primary outcomes

1

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.

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).
2

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."

Time frame
Baseline (previous MAM campaign) and immediately after completion of the modified MAM campaign (up to 4 weeks after intervention).
3

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.

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

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.

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

Secondary outcomes

1

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

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).
2

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

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).
3

Migration drivers identified among mobile and migrant populations through participatory assessment

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).
4

Community-defined implementation priorities for the modified MAM strategy

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).

Other outcomes

Sponsors and contacts

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Uwemedimo Friday Ekpo

Lead sponsor

Akwa Ibom State University, Ikot Akpaden, Nigeria

Sponsor institution

Mission To Save The Helpless

Collaborator

Marian University

Collaborator

Hellen Keller International

Collaborator

Nigerian Federal Ministry of Health

Collaborator