Clinical Research Directory

Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations

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.

Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh

Background (brief): 1. Burden: Soil-transmitted helminth (STH) infections are a major public health problem, primarily affecting children. Although STH prevalence has decreased to 14% in Bangladesh, over 47 million preschool- and school-age children still live in high-risk areas. 2. Knowledge gap: Albendazole shows 94-100% efficacy against A. lumbricoides but only 39-60% against T. trichuria. Ivermectin is also effective against hookworm and T. trichuria. Combining ivermectin with albendazole may be more effective than using either drug alone, but this combined therapy for STH has not yet been studied in Bangladesh. 3. Relevance: STHs significantly impact children's nutrition, hindering health, growth, cognition, and learning. The national deworming program achieved 98.3% treatment coverage, but only 76.2% of PSAC were dewormed using self-prescribed medicines. Hypothesis (if any): The combination therapy of Albendazole and Ivermectin is more effective than Albendazole alone for treating soil-transmitted helminths in preschool-age children in Bangladesh Objectives: 1. To compare the safety and efficacy of Albendazole and Ivermectin combination therapy with Albendazole monotherapy in preschool-aged children 2. To evaluate post-treatment egg reduction rates for various helminths at different time points 3. To determine the median time to re-infection following different anti-helminth interventions for various STH Methods: This Phase IIa single-blinded, randomized controlled trial will evaluate the safety and efficacy of ivermectin and albendazole combination therapy versus standard albendazole monotherapy for STH in 2-5 years in rural Belkuchi, Sirajganj. A total of 110 PSAC with confirmed STH will be randomly assigned to two treatment arms. Field activities and laboratory analysis will use the Kato-Katz technique for microscopic examination. Outcome measures/variables: * Evaluate the safety and efficacy of ivermectin and albendazole combination therapy for STH * Evaluate the statistically significant impact on patient clinical outcomes, cure rate, and egg reduction rate * Correlate changes in Cure Rate and Egg Reduction Rate for different STH at various time points