Table_1_Developing inclusive digital health diagnostic for schistosomiasis: a need for guidance via target product profiles.xlsx

IntroductionThe INSPIRED project aims to develop inclusive Digital Optical Diagnostic Devices (DODDs) for schistosomiasis, to support disease management by enabling rapid diagnostic results, to improve efficient data management to guide decision-making and to provide healthcare workers with critical health information to facilitate follow-up action. Due to the non-availability of Target Product Profiles (TPPs) for guiding the development of digital diagnostics for schistosomiasis, we explored existing diagnostic TPPs.MethodsUsing a curated open access database (Notion database), we studied a selection of TPPs for diagnosing infectious diseases, focusing on specifications related to digital health products for Neglected Tropical Diseases (NTDs).ResultsEighteen TPPs originating from 12 documents, covering 13 specific diseases, were selected and their characteristics were labeled and entered into the database. Further exploration of the database revealed several gaps, including a lack of stakeholder input, sustainability, and TPP availability. Other significant gaps related to digital health platform interconnectivity and data stewardship specifically in relation to digital diagnostics, including DODDs.DiscussionThese findings reflect two possible scenarios: (1) there is currently no need for digital diagnostic devices for schistosomiasis and, by extension for other NTDs; or (2) those needs are not yet covered by TPPs. Therefore, we recommend that digital health diagnostics are included in the use cases for schistosomiasis control and elimination, at least in the ideal/desirable scenario, as this will guide research and incentivize investment in digital health diagnostics for schistosomiasis.</p

Combined effectiveness of anthelmintic chemotherapy and WASH among HIV-infected adults

<div><p>Introduction</p><p>Current global helminth control guidelines focus on regular deworming of targeted populations for morbidity control. However, water, sanitation, and hygiene (WASH) interventions may also be important for reducing helminth transmission. We evaluated the impact of different potential helminth protective packages on infection prevalence, including repeated treatment with albendazole and praziquantel with and without WASH access.</p><p>Methodology/Principal findings</p><p>We conducted a cohort study nested within a randomized trial of empiric deworming of HIV-infected adults in Kenya. Helminth infections and infection intensity were diagnosed using semi-quantitative real-time PCR. We conducted a manual forward stepwise model building approach to identify if there are packages of interventions that may be protective against an STH infection of any species (combined outcome) and each helminth species individually. We conducted secondary analyses using the same approach only amongst individuals with no anthelmintis exposure. We used interaction terms to test for potential intervention synergy. Approximately 22% of the 701 stool samples provided were helminth-infected, most of which were of low to moderate intensity. The odds of infection with any STH species were lower for individuals who were treated with albendazole (aOR:0.11, 95%CI: 0.05, 0.20, p<0.001), adjusting for age and sex. Although most WASH conditions demonstrated minimal additional benefit in reducing the probability of infection with any STH species, access to safe flooring did appear to offer some additional protection (aOR:0.34, 95%CI: 0.20, 0.56, p<0.001). For schistosomiasis, only treatment with praziquantel was protective (aOR:0.30 95%CI: 0.14, 0.60, p = 0.001). Amongst individuals who were not treated with albendazole or praziquantel, the most protective intervention package to reduce probability of STH infections included safe flooring (aOR:0.34, 95%CI: 0.20, 0.59, p<0.001) and latrine access (aOR:0.59, 95%CI: 0.35, 0.99, p = 0.05). Across all species, there was no evidence of synergy or antagonism between anthelmintic chemotherapy with albendazole or praziquantel and WASH resources.</p><p>Conclusions/Significance</p><p>Deworming is effective in reducing the probability of helminth infections amongst HIV-infected adults. With the exception of safe flooring, WASH offers minimal additional benefit. However, WASH does appear to significantly reduce infection prevalence in adults who are not treated with chemotherapy.</p><p>Trial registration</p><p>ClinicalTrials.gov, <a target="_blank">NCT00507221</a>.</p></div

Proportion of positive results, interquartile range (IQR), minimum-maximum range, and median per diagnostic test at three different time points (baseline) of 24 <i>S. haematobium</i>-positive subjects.

<p>Proportion of positive results, interquartile range (IQR), minimum-maximum range, and median per diagnostic test at three different time points (baseline) of 24 <i>S. haematobium</i>-positive subjects.</p

Prevalent helminth infections.

<p>Prevalent helminth infections.</p

Optimal protective helminth interventions in adults without access to treatment identified through stepwise model building, by species (adjusted for sex and age) ¹.

<p>Optimal protective helminth interventions in adults without access to treatment identified through stepwise model building, by species (adjusted for sex and age) <a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0005955#t005fn001" target="_blank">¹</a>.</p

Participant (N = 701) characteristics (non-imputed).

<p>Participant (N = 701) characteristics (non-imputed).</p

Infection prevalence and intensity group as measured by real-time PCR (Ct-values) and microscopy (egg output) at the different examination time points.

<p>Infection prevalence and intensity group as measured by real-time PCR (Ct-values) and microscopy (egg output) at the different examination time points.</p

Spearman's correlation coefficients between values of each diagnostic tool before treatment, and two and 18 months post-treatment (N = 114).

<p>* <i>Note</i>: P-values <0.0001.</p><p>^** Values of real-time PCR are negative as low PCR Ct-values reflect high parasite-specific DNA loads and vice versa.</p

Cumulative percentages and median (IQR) of positive results for each diagnostic test, based on measurement of single urine samples, at three different examination time points of 114 selected <i>Schistosomiasis haematobium</i>-positive schoolchildren.

<p>* <i>Note</i>: missing data cSEA at two months post-treatment (N = 26).</p

The relationship between body mass index and dose received using the WHO Tablet Pole.

<p>The increase in tablet interval (from ½ tablet to 1) at a height of 160 cm appears as a gap in the study population. The horizontal lines present the range of an appropriate praziquantel dose between 30–60 mg/kg.</p