Gates Open ResearchPub Date : 2025-09-09eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16362.1
Jane A Shaw, Caleb Petersen, Andriette Hiemstra, Maynard Meiring, Osagie A Eribo, Christian Otum, Ilana van Rensburg, Ayanda Shabangu, Bronwyn Smith, Firdows Noor, Gerhard Walzl, Kevin B Urdahl, Dave Lewinsohn, Stephanus T Malherbe, Nelita du Plessis
{"title":"Mycobacterium tuberculosis growth inhibition by peripheral blood mononuclear cells from household contacts is not affected by previous SARS-CoV-2 infection.","authors":"Jane A Shaw, Caleb Petersen, Andriette Hiemstra, Maynard Meiring, Osagie A Eribo, Christian Otum, Ilana van Rensburg, Ayanda Shabangu, Bronwyn Smith, Firdows Noor, Gerhard Walzl, Kevin B Urdahl, Dave Lewinsohn, Stephanus T Malherbe, Nelita du Plessis","doi":"10.12688/gatesopenres.16362.1","DOIUrl":"10.12688/gatesopenres.16362.1","url":null,"abstract":"<p><strong>Background: </strong>There is a concern that SARS-CoV-2 infection may drive poor outcomes after <i>Mycobacterium tuberculosis</i> Mtb exposure and infection. We performed an <i>ex vivo</i> Mtb killing assay using peripheral blood mononuclear cells (PBMC) from three groups: healthy household contacts of people with active TB with and without serologic evidence of previous SARS-CoV-2 infection (COV+HHC and COV-HHC), and participants with active TB and previous SARS-CoV-2 (COV+TB+).</p><p><strong>Methods: </strong>Twenty participants per group from Cape Town, South Africa were classified according to SARS-CoV-2 anti-S and anti-N antibody tests. We infected PBMC from each participant at a MOI of 0.001 with Mtb strain H37Rv in a 4-day growth inhibition assay. Mycobacteria were quantified through inoculation into Bactec Mycobacteria Growth Indicator Tube (MGIT) liquid culture. PBMC from a subset of participants were infected in the presence of autologous time-matched serum and Mtb-uninfected control PBMCs were included.</p><p><strong>Results: </strong>There was no difference in the time to detection of Mtb or the normalised Mtb growth ratio (log10CFUsample - log10CFUcontrol) between groups in the standard protocol, or when infected cells from the COV+HHC and COV+TB+ (n=10 each) groups were cultured with autologous time-matched serum. The group with active TB demonstrated the best Mtb growth control. Extracellular Mtb measured by culturing the supernatants of the infected cell cultures also did not show any difference between groups. Five (14.3%) uninfected controls were culture positive.</p><p><strong>Conclusion: </strong>Our results show that previous SARS-CoV-2 does not affect the Mtb killing ability of circulating mononuclear immune cells <i>in vitro.</i> Previous SARS-CoV-2 is unlikely to affect the outcome of Mtb infection through this mechanism.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"69"},"PeriodicalIF":0.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12420909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-08-27eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16360.1
Shaun Palmer, Rebecca A Clark, Bridgette J Connell, Vanessa Mwebaza Muwanga, Arthur Coelho, Paul Ogongo, Carly Young
{"title":"Driving innovation from discovery to access: Meeting report of the 7 <sup>th</sup> Global Forum on TB Vaccines (8-10 October 2024, Rio de Janeiro, Brazil).","authors":"Shaun Palmer, Rebecca A Clark, Bridgette J Connell, Vanessa Mwebaza Muwanga, Arthur Coelho, Paul Ogongo, Carly Young","doi":"10.12688/gatesopenres.16360.1","DOIUrl":"10.12688/gatesopenres.16360.1","url":null,"abstract":"<p><p>We urgently need novel, effective, and accessible vaccines to end tuberculosis (TB) as a public health crisis. The 7th Global Forum on TB Vaccines was convened from 8-10 October 2024 in Rio de Janeiro, Brazil. Under the theme of \"Driving innovation from discovery to access,\" the program covered the breadth of TB vaccine research and development (R&D) through implementation, while underscoring the need for greater innovation and investments to advance development and ensure rapid, affordable, and equitable access. Participants shared the latest research on: approaches to diversify the TB vaccine pipeline, candidates advancing through late-stage trials toward licensure, and efforts to ensure new TB vaccines reach the populations that most need them. The forum provided a platform to learn from diverse experts across the field, including researchers, industry, funders, civil society, and affected communities. Participants examined cross-cutting enablers throughout, including opportunities to establish novel partnership and financing models, enhance open science, optimize R&D practices, and strengthen leadership and engagement with community members and high burden countries alike. In this report, we synthesize key themes and findings from the meeting, highlighting progress and priorities in the TB vaccine field.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"65"},"PeriodicalIF":0.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12391588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144950573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Advanced HIV disease during the first six months on antiretroviral therapy in Zambia: research protocol for a prospective, observational, multi-cohort study.","authors":"Thandiwe Ngoma, Aniset Kamanga, Nancy Scott, Allison Morgan, Anushka Reddy Marri, Taurai Makwalu, Lloyd Mulenga, Suilanji Sivile, Mariet Benade, Prudence Haimbe, Hilda Shakwelele, Sydney Rosen","doi":"10.12688/gatesopenres.16359.1","DOIUrl":"10.12688/gatesopenres.16359.1","url":null,"abstract":"<p><strong>Background: </strong>The proportion of HIV-positive individuals who present for initiation or re-initiation of antiretroviral therapy (ART) with advanced HIV disease (AHD) and are at risk for morbidity and mortality remains high throughout sub-Saharan Africa. In Zambia, where 20% of ART initiators are diagnosed with AHD, little is known about the characteristics of those starting ART with AHD, why treatment initiation is delayed, how AHD clinical management influences clinical and non-clinical outcomes, or implementation of national AHD guidelines at facility level.</p><p><strong>Protocol: </strong>AHD-Zambia is a mixed-methods observational study to describe AHD clients and care during the first six months after starting or re-starting ART in Zambia. The study will be conducted at 24 public sector primary health facilities in four provinces. It will enroll ART clients screened for AHD during a three-month data collection period (Cohort 1), clients screened for AHD in the 12 months prior to the data collection period (Cohort 2), patients hospitalized for AHD-related conditions (Cohort 3); and clinical providers at the study sites who manage clients with AHD (Cohort 4). Data collection will include quantitative surveys, medical record review during the 12 months before and after enrollment, qualitative interviews, and focus group discussions. Facility-level indicators will also be collected. Outcomes will include detailed profiles of AHD clients and their 6 and 12-month retention in care and viral suppression, provider and client views on barriers to and preferences for AHD care, and assessment of facility fidelity to AHD guidelines.</p><p><strong>Discussion: </strong>This study will generate a comprehensive profile of clients presenting with AHD in Zambia, including clinical, demographic, social, and behavioral characteristics, treatment outcomes, and barriers to providing guideline-compliant care. Findings will provide insight into the delivery of AHD services, identify gaps in implementation, and support improvements to retention and care during the early treatment period.</p><p><strong>Registration: </strong>Clinicaltrials.gov NCT06904456.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"66"},"PeriodicalIF":0.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12391586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144950571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-08-27eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16358.1
Musiliu Adeolu Adewole
{"title":"Precolonial Centralization, Koranic Education and School Participation in Nigeria.","authors":"Musiliu Adeolu Adewole","doi":"10.12688/gatesopenres.16358.1","DOIUrl":"10.12688/gatesopenres.16358.1","url":null,"abstract":"<p><p>Several studies have documented the persistence of economic development outcomes across space and over long periods. Other studies have argued that the reversal of fortune has also occurred over time and space. Since different areas of current Nigeria were once under the rule of states with different degrees of political centralization and later investment in Koranic, this study seeks to explore whether areas or districts under a more centralized political system are more likely to participate in large-scale school expansion programs, such as the 1976 Universal Primary Education (UPE) and 1999 Universal Basic Education (UBE). To check for evidence of the reversal of fortune, we determine whether the degree of state centralization on school participation is more or less in areas that have large investments in Koranic education. OLS results show that while an index of state centralization has a positive and significant impact on enrolment in UPE and UBE programs, the effect is negative and statistically significant for those with heavy investment in Koranic education (measured by district fraction of 1914-46 cohorts with Koranic education). The results are robust to adding an extensive range of explanatory variables and specification tests. While the structure of the economy at the onset of Islamic activities in Nigeria may have made investment in Koranic education worthwhile, the contemporary world does not require Koranic education to make either regional or national advancement possible. Thus, there is a clear case of mismatch between the demands of modern economic life and the skills possessed by a large section. Thus, well-designed policies are required to address this mismatch and accelerate inclusive economic development.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"67"},"PeriodicalIF":0.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12391587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144950510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-28eCollection Date: 2024-01-01DOI: 10.12688/gatesopenres.15399.2
Katherine Gleave, Giorgio Praulins, Rosemary Susan Lees
{"title":"Better methods, better data: landscaping the priorities for improving methodologies in vector control.","authors":"Katherine Gleave, Giorgio Praulins, Rosemary Susan Lees","doi":"10.12688/gatesopenres.15399.2","DOIUrl":"10.12688/gatesopenres.15399.2","url":null,"abstract":"<p><p>This article addresses the evolving challenges in evaluating insecticide-based tools for vector control. In response to the emergence of insecticide resistance in major malaria vectors, novel chemistries and products are coming to market, and there is a need to review the available testing methodologies. Commonly used methods for evaluating insecticides, such as the World Health Organization (WHO) cone bioassay, are inadequate for the diverse range of tools now available. Innovation to Impact (I2I) has studied the variability in laboratory methods, with the aim of identifying key factors that contribute to variation and providing recommendations to tighten up protocols. The I2I Methods Landscape is a living document which presents a review of existing methods for evaluating vector control tools, with the scope currently extending to insecticide-treated nets (ITNs) and indoor residual sprays (IRS). The review reveals a lack of validation for many commonly used vector control methods, highlighting the need for improved protocols to enhance reliability and robustness of the data that is generated to make decisions in product development, evaluation, and implementation. A critical aspect highlighted by this work is the need for tailored methods to measure endpoints relevant to the diverse modes of action of novel insecticides. I2I envisage that the Methods Landscape will serve as a decision-making tool for researchers and product manufacturers in selecting appropriate methods, and a means to prioritise research and development. We call for collective efforts in the pro-active development, validation, and consistent implementation of suitable methods in vector control to produce the data needed to make robust decisions.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"8 ","pages":"27"},"PeriodicalIF":0.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11259587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-28eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16354.1
Bonface Mujuri, Immaculate Kathomi
{"title":"The Role of Technical and Vocational Education relative to Academic Schooling in the Transition of the Youth to Labour Markets in Kenya.","authors":"Bonface Mujuri, Immaculate Kathomi","doi":"10.12688/gatesopenres.16354.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.16354.1","url":null,"abstract":"<p><p>This paper explores the role of Technical and Vocational Education & Training (TVET) relative to academic education in the transition of youths to the labor market in Kenya. Kenya's education system has experienced tremendous changes and diversification over the years, from replacing the old curriculum with the 8-4-4 system, and later transitioning to a competency-based curriculum, not to mention an overhaul of TVET via the Technical and Vocational Education and Training Act No. 29 of 2013. Due to these reforms, enrolment in TVET institutions has progressed upward over the past five years. The growth of the TVET sector has been promoted to help curb the rising rates of youth unemployment, but the evidence of the effectiveness of reforms to date has been sparse. The study provides evidence on two issues: (i) the effect of TVET on youth employment relative to academic education and (ii) the structure and status of the TVET sector in Kenya. We used quantitative and qualitative methodologies to generate the evidence. Findings demonstrate that youth with a TVET background have strong prospects of securing employment than those without TVET skills. However, the data from KIIs reveal gaps in the TVET sector that hinder graduates from competing effectively with their university counterparts in the labor market. The study recommends a review of the curriculum to promote holistic TVET training and match it with current technological innovations.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"51"},"PeriodicalIF":0.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12304420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-28eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16357.1
Misheck Mphande, Isabella Robson, Julie Hubbard, Eric Lungu, Elijah Chikuse, Khumbo Phiri, Morna Cornell, Sam Phiri, Thomas J Coates, Kathryn Dovel
{"title":"Developing a male-specific counselling curriculum for HIV treatment in Malawi.","authors":"Misheck Mphande, Isabella Robson, Julie Hubbard, Eric Lungu, Elijah Chikuse, Khumbo Phiri, Morna Cornell, Sam Phiri, Thomas J Coates, Kathryn Dovel","doi":"10.12688/gatesopenres.16357.1","DOIUrl":"10.12688/gatesopenres.16357.1","url":null,"abstract":"<p><strong>Background: </strong>Men living with HIV in sub-Saharan Africa have sub-optimal engagement in antiretroviral therapy (ART) programs. Generic ART counselling in Malawi does not meet men's needs.</p><p><strong>Methods: </strong>We developed a male-specific ART counselling curriculum, adapted from the Malawi Ministry of Health curriculum, based on literature review of men's needs and motivations for treatment. We piloted the curriculum with men in six communities, with focus group discussions to assess knowledge of ART, motivators and barriers to care, and perceptions of the male-specific curriculum (n=85). We analysed data in Atlas.ti using grounded theory. We finalised the curriculum in a half-day meeting with Ministry and partner stakeholders (n=5) and implemented it in two randomized trials (IDEaL and ENGAGE). We describe the steps to develop, test and finalize the curriculum.</p><p><strong>Results: </strong>We adapted three existing topics (status disclosure, treatment as prevention, and ART side effects) and added four new topics (how treatment contributes to men's goals, feeling healthy on treatment, navigating health systems, and self-compassion for the cyclical nature of lifelong treatment). Key motivators included: family wellbeing, having additional children, being financially stability, and earning/keeping respect. Men reported little prior understanding of how ART contributed to their personal goals, and were most interested in treatment as prevention, benefits of disclosure/social support, how to navigate health systems, and side effects with new regimens. Respondents stated that the male-specific counselling challenged the idea that men were incapable of overcoming treatment barriers to lifelong medication.</p><p><strong>Conclusion: </strong>Men need male-specific ART counselling curriculum to address their needs and increase access to and retention in HIV care. In the Malawi context, topics should include how treatment contributes to men's goals, navigating health systems, self-compassion for lifelong treatment, and taking treatment while healthy. Other countries with high HIV burdens and limited resources could follow the steps outlined in this paper. This curriculum is being evaluated within the two randomized trials.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"52"},"PeriodicalIF":0.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12304421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-24eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16356.1
Gerard E Ryan, Nicholas Tierney, Nick Golding, Daniel J Weiss
{"title":"traveltime: an R package to calculate travel time across a landscape from user-specified locations.","authors":"Gerard E Ryan, Nicholas Tierney, Nick Golding, Daniel J Weiss","doi":"10.12688/gatesopenres.16356.1","DOIUrl":"10.12688/gatesopenres.16356.1","url":null,"abstract":"<p><p>Understanding and mapping the time to travel among locations is useful for many activities from urban planning to public health and myriad others. Here we present a software package - traveltime - written in and for the language R. traveltime enables a user to create a raster map of the travel time over an area of interest from a user-specified set of locations defined by geographic coordinates. The result is a raster of the area of interest where the value in each cell is the lowest travel time in minutes to the nearest of the supplied locations. We envisage this software having diverse applications including: estimating sampling bias, allocating defibrillators, setting health districts, or mapping access to vehicle chargers and agricultural facilities. The work-flow requires two key steps: preparing a friction surface for the area of interest, and then calculating travel time over that surface for the points of interest. traveltime is available from R-Universe and GitHub, and documented at https://idem-lab.github.io/traveltime/.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"50"},"PeriodicalIF":0.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144729566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-24eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16355.1
Alexandria J R Harrott, Collins M Morang'a, Richard D Pearson, Mona-Liza Sakyi, Ahmed Osumanu, Enock K Amoako, Fagdéba David Bara, Myra Hosmillo, Kess Rowe, Yaw Aniweh, Gordon A Awandare, Francis Zeukeng, Ian Goodfellow, Cristina V Ariani, Lucas N Amenga-Etego, William L Hamilton
{"title":"An expanded method for malaria parasite genetic surveillance using targeted nanopore sequencing.","authors":"Alexandria J R Harrott, Collins M Morang'a, Richard D Pearson, Mona-Liza Sakyi, Ahmed Osumanu, Enock K Amoako, Fagdéba David Bara, Myra Hosmillo, Kess Rowe, Yaw Aniweh, Gordon A Awandare, Francis Zeukeng, Ian Goodfellow, Cristina V Ariani, Lucas N Amenga-Etego, William L Hamilton","doi":"10.12688/gatesopenres.16355.1","DOIUrl":"10.12688/gatesopenres.16355.1","url":null,"abstract":"<p><p>Malaria causes around 250 million cases and over 600,000 deaths annually, with the heaviest burden falling on young children living in sub-Saharan Africa. Molecular surveillance of <i>Plasmodium</i> parasites and <i>Anopheles</i> mosquito vectors are key components of effective malaria control decision-making. Previously, we have designed and implemented a nanopore-based workflow for targeted <i>P. falciparum</i> molecular surveillance in Ghana, which we call DRAG1 (drug resistance + antigen multiplex PCR). Here, we describe an updated and expanded multiplex assay ('DRAG2') with additional amplicon targets that incorporate more antimalarial drug resistance markers, the polymorphic surface antigen <i>merozoite surface protein 2</i> ( <i>msp2</i>), and the 18S ribosomal RNA (rRNA) gene for <i>Plasmodium</i> species detection. We describe the performance of the DRAG2 assay over a range of parasitaemias and sample types (venous blood and dried blood spots), with suggested systems of quality control including the use of synthetic plasmids for positive controls and recommended coverage thresholds. The plasmids are highly economical, and engineered to include both 'test' single nucleotide polymorphisms (SNPs), such as known drug resistance markers, and 'control' SNPs, which are not found in nature and thus signal contamination if detected in clinical samples. We provide standard operating procedures (SOPs) for use by teams aiming to implement the assay in their laboratory. In summary, we describe an updated nanopore-based method for malaria molecular surveillance, including detailed consideration of quality control processes and SOPs. These are important steps in the transition from research tool to diagnostic assay, which will require further testing in endemic settings and regulatory processes and approvals.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"49"},"PeriodicalIF":0.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144729565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gates Open ResearchPub Date : 2025-07-15eCollection Date: 2025-01-01DOI: 10.12688/gatesopenres.16352.1
Valerie L Flax, Narjis Rizvi, Umesh Charantimath, Saleem Jessani, Avinash Kavi, Sarah Saleem, Manjunath Somannavar, Shivaprasad S Goudar, Anika Hannan, Elizabeth M McClure, Simal Thind, Rosemary Frasso, Richard Derman
{"title":"PRIORITY IR: Protocol for implementation research on single-dose postpartum IV iron to treat iron-deficiency anemia among women in India and Pakistan.","authors":"Valerie L Flax, Narjis Rizvi, Umesh Charantimath, Saleem Jessani, Avinash Kavi, Sarah Saleem, Manjunath Somannavar, Shivaprasad S Goudar, Anika Hannan, Elizabeth M McClure, Simal Thind, Rosemary Frasso, Richard Derman","doi":"10.12688/gatesopenres.16352.1","DOIUrl":"10.12688/gatesopenres.16352.1","url":null,"abstract":"<p><strong>Background: </strong>Anemia among women of reproductive age has remained highly prevalent globally. Intravenous (IV) iron is well tolerated and proven effective for treating postpartum iron deficiency anemia in high-income countries, but evidence from LMICs, where oral iron is standard treatment, is limited. The PRIORITY trial will test the effectiveness of IV iron compared to oral iron for postpartum women with moderate anemia in eight LMIC sites. An implementation research (IR) study will be conducted alongside the PRIORITY trial in India and Pakistan to gather information on the intervention characteristics and the implementation process, and to assess feasibility, acceptability, fidelity, and cost of implementation for providing IV iron to postpartum women with moderate iron deficiency anemia.</p><p><strong>Methods: </strong>The PRIORITY IR study will use a mixed methods convergent parallel design guided by two frameworks: the Consolidated Framework for Implementation Research and Proctor's implementation outcomes. The IR study will be conducted in the Belagavi, India and Karachi, Pakistan PRIORITY trial sites. Participants will include postpartum women in the IV iron intervention arm of the trial, family members, health workers administering IV iron, hospital administrators, postpartum women who refuse to be part of the trial (Pakistan only), and postpartum women in the oral iron arm of the trial (India only). Data collection methods will include surveys, in-depth interviews, a supervision checklist, and a cost assessment. Survey and supervision checklist data will be analyzed descriptively. Interview data will be analyzed using a directed content analysis approach.</p><p><strong>Discussion: </strong>The PRIORITY IR study will contribute important information about implementation processes and strategies and feasibility, acceptability, fidelity, and costs for postpartum IV iron implementation. Results of the study can provide guidance for implementing effective anemia treatment in LMIC contexts with a high anemia burden.</p><p><strong>Registration: </strong>NCT05590260 (21/10/2022), CTRI/2022/10/046632 (19/10/2022), CTRI/2023/05/053302 (31/05/2023).</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"9 ","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12264235/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}