Project Protocol and Overview

Title: Foldscope & Microfluidics: Accessible Diagnostics for Community-led Schistosomiasis Control

Protocol Summary: This study aims to evaluate the effectiveness of the Foldscope, a low-cost paper microscope, for diagnosing Schistosoma haematobium in urine samples within rural Nigerian communities in Ogun State. The project will assess diagnostic accuracy, community acceptability, and feasibility of implementation through collaboration with local community health extension workers and volunteers. The study will compare Foldscope-based microscopy with conventional methods, focusing on sensitivity, specificity, and cost-effectiveness. The expected benefit is the development of a sustainable, community-based tool for screening schistosomiasis in rural areas. 

Scope of the Problem

Schistosomiasis poses a significant public health challenge in Nigeria, where it disproportionately affects vulnerable populations in resource-limited and rural communities. Studies have found highest prevalence rates of schistosomiasis in school-aged children, and high prevalence of urogenital schistosomiasis in Sub-Saharan Africa despite ongoing mass drug administration with praziquantel (Archer et al., 2024; Faust et al., 2021; Mtethiwa et al., 2015). Classic symptoms include hematuria, abdominal pain, and fatigue (WHO, 2023). Of particular concern is the development of female genital schistosomiasis (FGS), which can harm female reproductive organs and increase the risk for infertility, as well as HPV infection. FGS has been highly associated with bladder cancer, particularly squamous cell carcinoma and cervical cancer, which is associated with the high rates of HPV infection in patients with FGS (Chatterji et al., 2024). Despite national control programs, efforts such as mass drug administration and environmental interventions have shown limited success in fully extinguishing disease burden in Sub-Saharan Africa due to continued transmission, emphasizing the need for innovative and sustainable diagnostic and surveillance strategies (Knopp et al., 2019). Diagnosis of schistosomiasis continues to face logistical barriers, particularly in rural areas with resource limitations, where new diagnostic solutions are needed (Archer et al., 2024). Climate change is exacerbating the schistosomiasis burden in endemic areas, as rising temperatures and altered rainfall patterns are expanding the geographical range and seasonality of Schistosoma snail vectors (Deure et al., 2024). As this problem poses multifactorial challenges, a community-based, low-expense solution for diagnosing Schistosoma haematobium in urinary samples is needed.

Project Objectives

• Evaluate the effectiveness of Foldscope-based microscopy: Assess the sensitivity and specificity of Foldscope technology in detecting Schistosoma haematobium eggs in urine samples, with a focus on field applicability in high-burden Nigerian communities.

• Assess qualitative feasibility of Foldscope-based microscopy: Understand how the Foldscope compares to traditional diagnostic methodologies by assessing ease of use, diagnostic time requirements, and training needs for community health providers.

• Assess community acceptability and barriers to implementation: Investigate how local health workers and community volunteers perceive the use of Foldscope for schistosomiasis screening, including ease of use, training requirements, and overall effectiveness in field conditions.

Step One: Lab Verification

In March 2025, we began lab-based verification of the Foldscope's capacity to visualize and diagnose schistosomiasis eggs. We analyzed the Foldscope relative to traditional light microscopy (gold standard) and compared the results of expert versus novice users. We found that the Foldscope has a 100% specificity for correctly diagnosing schistosomiasis (no false positives) and a 72% sensitivity for correctly ruling out schistosomiasis (few false negatives). 

Step Two: Field-Based Pilot Study

In April 2025, we will launch the beginning of our pilot study in Abeokuta, Nigeria. Here, we will be working in two rural communities to conduct preliminary assessments of the Foldscope's utility in diagnosing schistosomiasis. We will elicit in-depth feedback from participants and community stakeholders, collaborate closely with local academic, governmental and community leaders, and troubleshoot challenges that arise. 

Step Three: Expanded Field Study

In 2026, we hope to build off a successful pilot study by expanding our study sites and sample size. We will continue to work closely with our partners in Ogun State, Nigeria and plan to expand to new sites in southeast Tanzania. We will closely monitor the Foldscope's efficacy, community considerations such as usability and acceptability, practical Foldscope design changes, and improvements in clinical practice and outcomes to ensure the Foldscope is ready for expanded utilization. 

Step Four: Community-Led Diagnostics

The vision of the HIYH project is to equip communities with accessible tools to diagnose schistosomiasis infections, preventing disease and improving overall community well-being. After ensuring the Foldscope meets these metrics, we hope to roll out a multi-country community-sustained program. Equipping communities in endemic areas with the Foldscope, we envision training community diagnostic educators who can in turn serve as education liaisons to community health workers and frontline clinicians in their region. We are strongly focused on the tangible and practical sustainability of the program, including ensuring the physical parts needed are accessible/durable and developing networks of local stakeholders engaged in the ongoing support and education of community health workers using the Foldscopes in their own communities.