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    Gates open research

    Gates open research

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    1Characterizing Multi-Criteria Decision Analysis, Risk Stratification, and Hotspot Analysis Methods to Optimise Health Policymaking and Evidence Translation for Medicines in Low- and Middle-Income Countries: A Scoping Review [version 1; Peer Review: Awaiting Peer Review]
    Luke E. Norris, Patricia N. Okorie, Tessa Rose Cornell, Louise A. Kelly-Hope, Lily-May Hudson

    Background Implementing new medicines or health interventions in lower-income and middle-income countries (LMICs) may be complex and challenging, and there is a need for practical structured approaches and tools to support the translation of evidence into practice, including the implementation of evidence-informed interventions and health policy making. Objective This scoping review aimed to characterise three data analytical methodologies - multi-criteria decision analysis (MCDA), risk stratification, and hotspot analysis - to evaluate their use in guiding the implementation of medicines for human health in LMICs between 2010-2025. Methods Scientific articles were searched in databases PubMed and Scopus following guidelines from the Preferred Items for Systematic Reviews and Meta-Analysis (PRISMA). Data were extracted in relation to the study aims, geographic scope and scale, author affiliations, disease focus, medicine type (categorised as oral drugs or vaccines), target population, medicine implementation phase, use of templates or tools, and main steps of the methodological process. In addition, grey literature was searched by reviewing conference abstracts, national public health websites and journals. Results From the 4,920 articles screened, a total of 40 articles (MCDA=8, risk stratification= 22, hotspot analysis=10) were included from 28 countries across five global regions, mostly Africa. Most articles focused on communicable infectious diseases, and drugs (oral regimens) and vaccines in the pre-implementation stage at a sub-national level. The processes and techniques used for each analytical method varied widely, limiting comparability. However, common methodological steps were identified and used to construct preliminary templates to summarise the processes involved in applying each methodology and support their potential adaptations for decision-making around medicine implementation. Conclusion These analytical methodologies provide a structured basis for further developing practical templates and decision-support tools to enhance the medicine translation; however, efforts are needed to raise awareness, strengthen capacity, and facilitate greater uptake.

    2026
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    2Analytical Performance and Clinical Usability of a Low-Cost Vaginal Swab for Sensitive Detection of High-Risk Human Papillomavirus [version 1; Peer Review: Awaiting Peer Review]
    Vimarsh Joshi, Rebecca Amaru, William Bennett, Jessica Wicker, Bridgette Mastaglio, Leyla Solis, Lindsey B Turnbull, Ninette Cohen, Jared Luchetta, Victor Omballa

    Background Cervical cancer remains a global health burden, with >600,000 new cases and 340,000 deaths reported in 2020. To reduce this burden, affordable and scalable human papillomavirus (HPV) diagnostics - ranging from at-home to centralized laboratory testing - are needed. Specimen collection plays a key role in analytical performance, sample integrity/stability, platform compatibility and user comfort. Methods We evaluated the analytical performance and temperature stability of high-risk HPV (hrHPV) plasmid DNA and human cervical cancer cell lines on a low-cost Steripack XpressCollect flocked nylon swab using the Atila ScreenFire HPV risk stratification (RS) assay, the Cepheid Xpert HPV assay, and the Molbio Truenat HPV-HR Plus assay. We assessed the clinical usability among women seeking sexual and reproductive healthcare in New York, New York. Results The Atila ScreenFire HPV RS assay was more sensitive in detection of HPV. We demonstrated statistically improved elution efficiency from the low-cost Steripack XpressCollect flocked nylon swab relative to Copan FLOQSwabs. Additionally, dry-stored flocked nylon swabs preserved sample integrity better than swabs stored in Tris-EDTA buffer over time with varying temperatures. Frozen HPV lysates remained stable for up to three months including during freeze/thaw cycles. Among healthcare provider-collected swabs, 7.5% were HPV positive and among the self-collected swabs, 20% were HPV positive. Of those with self-collected swabs, 97% had no previous self-swabbing experience, 71% preferred self-swabbing to healthcare provider-collected swabbing, 93% found it very easy or easy to self-swab and 100% were willing to provide self-swabbing at follow-up. Conclusion The use of dry-stored, nylon-flocked vaginal swabs paired with platform-agnostic assays, like the Atila ScreenFire HPV RS and other genotyping assay, offers a practical and robust solution for hrHPV genotyping in resource-limited settings. Additionally, self-swabbing using low-cost vaginal swabs was highly accepted and retained equivalent sensitivity, further justifying its widespread use in underserved communities.

    2026
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    3The Current Status of the Demographic and Health Surveys Program [version 1; Peer Review: Awaiting Peer Review]
    Madeleine Short Fabic

    -->This open letter offers insight into the status of The Demographic and Health Surveys Program and invites readers and other members of the global health community to continue joining in collaborative, future-oriented design and creation for the program’s longevity and evolution.

    2026
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    4Long-acting Injectables for Global Health: Drug Development Considerations and Applications in Malaria and Tuberculosis [version 1; Peer Review: Awaiting Peer Review]
    Fran Berlioz-Seux, Jeremy Burrows, Benoît Bestgen, Zedong Dong, Tomas Cihlar, Nathalie Gobeau, Debra Flood, Paul Jackson,René Holm, Mike Morimoto, Linu John, Hanu Ramachandruni,

    Long-acting injectable (LAI) drug formulations represent a transformative modality in modern therapeutics, delivering medications that maintain therapeutic effects over extended periods. While initially developed to improve patient adherence and acceptability for applications such as hormonal contraception and chronic conditions, including psychiatric disorders, their recent success in HIV treatment and prevention has catalyzed a growing interest in their application to global health priorities. While there are effective oral drug regimens available for tuberculosis (TB) treatment and malaria chemoprevention, their dosing regimens challenge patient adherence. By providing sustained pharmacological activity over extended periods, LAIs decouple therapeutic efficacy from patient adherence and simplify drug dosing regimens, enhancing real-world effectiveness. This position paper synthesizes the emerging consensus on the application of LAIs for global health from a multidisciplinary expert workshop convened by Medicines for Malaria Venture (MMV) and the Gates Foundation in Chicago on March 17–19, 2026. Contributions considered compound selection, formulation design, pharmacokinetic and pharmacodynamic requirements, safety and tolerability profiles, toxicology packages for first-in-human studies, regulatory pathways, and the challenges of human dose prediction. Emphasis was placed on the importance of preclinical-to-clinical translation, particularly through the application of pharmacometric tools and model-informed drug development. The workshop highlighted strategic priorities for advancing the LAI field, including coordinated cross-sector approaches, pre-competitive data sharing, and communities of practice to address critical knowledge gaps. These actions aim to realize the potential for expanding LAI technologies to advance global health.

    2026
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    5Health System Readiness for Immediate Kangaroo Mother Care (ikmc) among Network of Care Facilities in the Sidama Region, Ethiopia: a Mixed-Method Study [version 1; Peer Review: Awaiting Peer Review]
    Setisemhal Getachew, Hailemariam Negash, Akalewold Alemayehu, Dorka Woldesenbet Keraga, Meles Solomon, Mekdes Shifeta Argaw, Siren Rettedal, Fitsum Woldegabriel Belay,Anayda Portela,Sachiyo Yoshida, Abiy Seifu Estifanos

    Introduction Despite Ethiopia’s remarkable progress in reducing deaths among children under five, neonatal mortality remains high. The provision of immediate Kangaroo Mother Care (iKMC) for clinically unstable preterm and low-birth-weight (LBW) newborns has proven effective in lowering neonatal mortality related to preterm newborns. This study aimed to assess Ethiopia’s health system readiness to integrate iKMC into Level 2 small and sick newborn care (SSNC) units, with a focus on a selected network-of-care facilities in the Sidama region. Methods We employed a mixed-method design. Through a cross-sectional quantitative facility mapping across a network of 25 facilities, data were electronically captured and analyzed in SPSS using descriptive statistics. The qualitative assessment included in-depth interviews and focus group discussions with mothers and family members of preterm or LBW newborns and a range of stakeholders. Data were coded, thematized, and analyzed using the World Health Organization health systems building blocks and the SSNC continuum of care. Results Out of the 25 facilities, 8 (32.0%) had inpatient newborn care units (NCUs) and attended to 16,843 (68.4%) of all mapped births, 1,044 (96.6%) of all preterm births, and 1,143 (94.0%) of all LBW births recorded in the 12-months preceding the assessment. Four facilities with NCUs, admitting 93.4% of preterm and 88.2% of LBW newborns from the catchment area, were identified as eligible to introduce iKMC. All four iKMC-eligible facilities provided antenatal corticosteroids, had trained dedicated health workers to care for preterm or LBW newborns, and offered KMC. Although insufficient, they also had SSNC devices and infrastructure. The qualitative assessment identified facilitators and barriers related to the health system, families’ knowledge, attitudes, engagement, and support, and mothers’ household responsibilities. Conclusion Despite notable health system gaps, hospitals with inpatient NCUs demonstrated modest readiness and willingness to introduce iKMC and create a mother-newborn couplet model of care approach.

    2026
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