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  1. Article ; Online: Malaria prevention: advancing clinical trials to policy.

    Laufer, Miriam K / Mungwira, Randy G / Divala, Titus H

    The Lancet. Infectious diseases

    2024  Volume 24, Issue 5, Page(s) 439–440

    MeSH term(s) Humans ; Malaria/prevention & control ; Clinical Trials as Topic ; Health Policy ; Antimalarials/therapeutic use
    Chemical Substances Antimalarials
    Language English
    Publishing date 2024-01-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(23)00808-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: COVID-19 self-testing: Countries accelerating policies ahead of WHO guidelines during pandemics, a global consultation.

    Sakala, Melody / Johnson, Cheryl / Chirombo, James / Sacks, Jilian A / Baggaley, Rachel / Divala, Titus

    PLOS global public health

    2024  Volume 4, Issue 3, Page(s) e0002369

    Abstract: The widespread use of antigen-detection rapid diagnostic tests (Ag-RDTs) has revolutionized SARS-CoV-2 (COVID-19) testing, particularly through the option of self-testing. The full extent of Ag-RDT utilization for self-testing, however, remains largely ... ...

    Abstract The widespread use of antigen-detection rapid diagnostic tests (Ag-RDTs) has revolutionized SARS-CoV-2 (COVID-19) testing, particularly through the option of self-testing. The full extent of Ag-RDT utilization for self-testing, however, remains largely unexplored. To inform the development of WHO guidance on COVID-19 self-testing, we conducted a global consultation to gather the views and experiences of policy makers, researchers, and implementers worldwide. The consultation was conducted by disseminating a WHO questionnaire through professional networks via email and social media, encouraging onward sharing. We used a cross-sectional design with both closed and open-ended questions related to policy and program information concerning the regulation, availability, target population, indications, implementation, benefits, and challenges of COVID-19 self-testing (C19ST). We defined self-testing as tests performed and interpreted by an untrained individual, often at home. Descriptive summaries, cross-tabulations, and proportions were used to calculate outcomes at the global level and by WHO region and World Bank income classifications. All information was collated and reported according to WHO guideline development standards and practice for global consultations. Between 01 and 11 February 2022, 844 individuals from 139 countries responded to the survey, with 45% reporting affiliation with governments and 47% operating at the national level. 504 respondents from 101 countries reported policies supporting C19ST for a range of use cases, including symptomatic and asymptomatic populations. More respondents from low-and-middle-income countries (LMICs) than high-income countries (HICs) reported a lack of an C19ST policy (61 vs 11 countries) and low population-level reach of C19ST. Respondents with C19ST experience perceived that the tests were mostly acceptable to target populations, provided significant benefits, and highlighted several key challenges to be addressed for increased success. Reported costs varied widely, ranging from specific programmes enabling free access to certain users and others with high costs via the private sector. Based on this consultation, systems for the regulatory review, policy development and implementation of C19ST appeared to be much more common in HIC when compared to LIC in early 2022, though most respondents indicated self-testing was available to some extent (101 out of 139 countries) in their country. Addressing such global inequities is critical for ensuring access to innovative and impactful interventions in the context of a public health emergency of international concern. The challenges and opportunities highlighted by key stakeholders could be valuable to consider as future testing strategies are being set for outbreak-prone diseases.
    Language English
    Publishing date 2024-03-18
    Publishing country United States
    Document type Journal Article
    ISSN 2767-3375
    ISSN (online) 2767-3375
    DOI 10.1371/journal.pgph.0002369
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Investigating the characteristics of health-related data collection tools used in randomised controlled trials in low-income and middle-income countries: protocol for a systematic review.

    Karthikeyan, Rithvik / Al-Shamaa, Noor / Kelly, Eve Jacqueline / Henn, Patrick / Shiely, Frances / Divala, Titus / Fadahunsi, Kayode Philip / O'Donoghue, John

    BMJ open

    2024  Volume 14, Issue 1, Page(s) e077148

    Abstract: Introduction: Health-related data collection tools, including digital ones, have become more prevalent across clinical studies in the last number of years. However, using digital data collection tools in low-income and middle-income countries presents ... ...

    Abstract Introduction: Health-related data collection tools, including digital ones, have become more prevalent across clinical studies in the last number of years. However, using digital data collection tools in low-income and middle-income countries presents unique challenges. In this review, we aim to provide an overview of the data collection tools currently being used in randomised controlled trials (RCTs) conducted in low-resource settings and evaluate the tools based on the characteristics outlined in the modified Mobile Survey Tool framework. These include functionality, reliability, usability, efficiency, maintainability, portability, effectiveness, cost-benefit, satisfaction, freedom from risk and context coverage. This evidence may provide a guide to selecting a suitable data collection tool for researchers planning to conduct research in low-income and middle-income countries for future studies.
    Methods and analysis: Searches will be conducted in four electronic databases: PubMed, CINAHL, Web of Science and EMBASE. For inclusion, studies must be a RCT, mention a health-related data collection tool and conducted in a low- and middle-income country. Only studies with available full-text and written in English will be included. The search was restricted to studies published between January 2005 and June 2023. This systematic review will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) tool. Two review authors will screen the titles and abstracts of search results independently for inclusion. In the initial screening process, the full-text articles will be retrieved if the abstract contains limited information about the study. Disagreements will be resolved through discussion. If the disagreement cannot be resolved, a third author (JO'D) will adjudicate. The study selection process will be outlined in a PRISMA flow-diagram. Data will be analysed using a narrative synthesis approach. The included studies and their outcomes will be presented in a table.
    Ethics and dissemination: Formal ethical approval is not required as primary data will not be collected in this study. The findings from this systematic review will be published in a peer-reviewed journal.
    Prospero registration number: CRD42023405738.
    MeSH term(s) Humans ; Cost-Benefit Analysis ; Data Collection ; Developing Countries ; Poverty ; Randomized Controlled Trials as Topic ; Review Literature as Topic ; Systematic Reviews as Topic
    Language English
    Publishing date 2024-01-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2023-077148
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: The remarkable tenacity of sulfadoxine-pyrimethamine.

    Divala, Titus H / Cohee, Lauren M / Laufer, Miriam K

    The Lancet. Infectious diseases

    2019  Volume 19, Issue 5, Page(s) 460–461

    MeSH term(s) Africa ; Drug Combinations ; Humans ; Malaria ; Plasmodium falciparum ; Pregnancy ; Pyrimethamine ; Sulfadoxine
    Chemical Substances Drug Combinations ; fanasil, pyrimethamine drug combination (37338-39-9) ; Sulfadoxine (88463U4SM5) ; Pyrimethamine (Z3614QOX8W)
    Language English
    Publishing date 2019-03-25
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(18)30796-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The Association among Malaria in Pregnancy, Neonatal inflammation, and Neurocognitive Development in a Cohort of Malawian Infants.

    Buchwald, Andrea G / Boudova, Sarah / Peterson, Ingrid / Divala, Titus / Mungwira, Randy / Mawindo, Patricia / Gladstone, Melissa / Cairo, Cristiana / Laufer, Miriam K

    The American journal of tropical medicine and hygiene

    2022  Volume 107, Issue 5, Page(s) 1036–1040

    Abstract: Malaria in pregnancy (MIP) causes poor birth outcomes, but its impact on neurocognitive development has not been well characterized. Between 2012 and 2014, we enrolled 307 mother-infant pairs and monitored 286 infants for neurocognitive development using ...

    Abstract Malaria in pregnancy (MIP) causes poor birth outcomes, but its impact on neurocognitive development has not been well characterized. Between 2012 and 2014, we enrolled 307 mother-infant pairs and monitored 286 infants for neurocognitive development using the Malawi Developmental Assessment Tool at 6, 12, and 24 months of age. MIP was diagnosed from peripheral blood and placental specimens. Cord blood cytokine levels were assessed for a subset of neonates. Predictors of neurodevelopment were examined using mixed-effect logistic regression for developmental delay. Among the participants, 78 mothers (25.4%) had MIP, and 45 infants (15.7%) experienced severe neurocognitive delay. MIP was not associated with differences in cord blood cytokine levels or neurocognitive development. Preterm birth, low birthweight, increasing maternal education level, and increasing interleukin 6 levels were associated significantly with delay. The results highlight the prevalence of severe delay and a need for broad access to early childhood support in this setting.
    MeSH term(s) Child, Preschool ; Infant ; Infant, Newborn ; Pregnancy ; Female ; Humans ; Premature Birth ; Placenta ; Malaria/complications ; Malaria/epidemiology ; Inflammation ; Cytokines
    Chemical Substances Cytokines
    Language English
    Publishing date 2022-10-17
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2942-7
    ISSN 1476-1645 ; 0002-9637
    ISSN (online) 1476-1645
    ISSN 0002-9637
    DOI 10.4269/ajtmh.22-0409
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Book ; Online: Uso de pruebas de diagnóstico rápido de detección de antígenos del SARS-CoV-2 para el autodiagnóstico de la COVID-19

    Divala, Titus / Sakala, Melody / Chirombo, James / Baggaley, Rachel / Sacks, Jilian A. / Johnson, Cheryl

    orientaciones provisionales, 9 de marzo de 2022: anexo D de la web. encuesta mundial sobre el autodiagnóstico de la COVID-19 con PDR-Ag del SARS-CoV-2

    2022  

    Abstract: 5 p. ...

    Abstract 5 p.
    Keywords COVID-19 ; COVID-19 Testing ; Betacoronavirus ; Disease Outbreaks ; Diagnostic Tests ; Routine ; Sensitivity and Specificity ; Reagent Kits ; Diagnostic ; Self-Testing ; Guidelines as Topic ; Surveys and Questionnaires ; diagnosis
    Language Spanish
    Publisher Organización Mundial de la Salud
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Book ; Online: Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing

    Divala, Titus / Sakala, Melody / Chirombo, James / Baggaley, Rachel / Sacks, Jilian A. / Johnson, Cheryl

    interim guidance, 9 March 2022: web annex D: global survey on COVID-19 self-testing using SARS-CoV-2 Ag-RDTs

    2022  

    Abstract: 6 p. ...

    Abstract 6 p.
    Keywords COVID-19 ; COVID-19 Testing ; Betacoronavirus ; Disease Outbreaks ; Diagnostic Tests ; Routine ; Sensitivity and Specificity ; Reagent Kits ; Diagnostic ; Self-Testing ; Guidelines as Topic ; Surveys and Questionnaires ; diagnosis
    Language English
    Publisher World Health Organization
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Africa faces difficult choices in responding to COVID-19.

    Divala, Titus / Burke, Rachael M / Ndeketa, Latif / Corbett, Elizabeth L / MacPherson, Peter

    Lancet (London, England)

    2020  Volume 395, Issue 10237, Page(s) 1611

    MeSH term(s) Africa/epidemiology ; Betacoronavirus ; COVID-19 ; Communicable Disease Control/methods ; Communicable Disease Control/organization & administration ; Coronavirus Infections/mortality ; Coronavirus Infections/prevention & control ; Health Services Accessibility ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/mortality ; Pneumonia, Viral/prevention & control ; Risk Assessment ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-05-12
    Publishing country England
    Document type Letter
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(20)31056-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Effect of adverse events on non-adherence and study non-completion in malaria chemoprevention during pregnancy trial: A nested case control study.

    Patson, Noel / Mukaka, Mavuto / Peterson, Ingrid / Divala, Titus / Kazembe, Lawrence / Mathanga, Don / Laufer, Miriam K / Chirwa, Tobias

    PloS one

    2022  Volume 17, Issue 1, Page(s) e0262797

    Abstract: Background: In drug trials, adverse events (AEs) burden can induce treatment non-adherence or discontinuation. The non-adherence and discontinuation induce selection bias, affecting drug safety interpretation. Nested case-control (NCC) study can ... ...

    Abstract Background: In drug trials, adverse events (AEs) burden can induce treatment non-adherence or discontinuation. The non-adherence and discontinuation induce selection bias, affecting drug safety interpretation. Nested case-control (NCC) study can efficiently quantify the impact of the AEs, although choice of sampling approach is challenging. We investigated whether NCC study with incidence density sampling is more efficient than NCC with path sampling under conditional logistic or weighted Cox models in assessing the effect of AEs on treatment non-adherence and participation in preventive antimalarial drug during pregnancy trial.
    Methods: Using data from a trial of medication to prevent malaria in pregnancy that randomized 600 women to receive chloroquine or sulfadoxine-pyrimethamine during pregnancy, we conducted a NCC study assessing the role of prospectively collected AEs, as exposure of interest, on treatment non-adherence and study non-completion. We compared estimates from NCC study with incidence density against those from NCC with path sampling under conditional logistic and weighted Cox models.
    Results: Out of 599 women with the outcomes of interest, 474 (79%) experienced at least one AE before delivery. For conditional logistic model, the hazard ratio for the effect of AE occurrence on treatment non-adherence was 0.70 (95% CI: 0.42, 1.17; p = 0.175) under incidence density sampling and 0.68 (95% CI: 0.41, 1.13; p = 0.137) for path sampling. For study non-completion, the hazard ratio was 1.02 (95% CI: 0.56, 1.83; p = 0.955) under incidence density sampling and 0.85 (95% CI: 0.45, 1.60; p = 0.619) under path sampling. We obtained similar hazard ratios and standard errors under incidence density sampling and path sampling whether weighted Cox or conditional logistic models were used.
    Conclusion: NCC with incidence density sampling and NCC with path sampling are practically similar in efficiency whether conditional logistic or weighted Cox analytical methods although path sampling uses more unique controls to achieve the similar estimates.
    Trial registration: ClinicalTrials.gov: NCT01443130.
    MeSH term(s) Antimalarials/therapeutic use ; Case-Control Studies ; Chemoprevention/methods ; Chloroquine/therapeutic use ; Data Analysis ; Drug Combinations ; Female ; Humans ; Incidence ; Malaria/drug therapy ; Malaria/epidemiology ; Medication Adherence/psychology ; Models, Theoretical ; Pregnancy ; Pregnancy Complications, Parasitic/epidemiology ; Pyrimethamine/therapeutic use ; Sulfadoxine/therapeutic use
    Chemical Substances Antimalarials ; Drug Combinations ; fanasil, pyrimethamine drug combination (37338-39-9) ; Sulfadoxine (88463U4SM5) ; Chloroquine (886U3H6UFF) ; Pyrimethamine (Z3614QOX8W)
    Language English
    Publishing date 2022-01-19
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0262797
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: "We usually see a lot of delay in terms of coming for or seeking care": an expert consultation on COVID testing and care pathways in low- and middle-income countries.

    Bonnet, Gabrielle / Bimba, John / Chavula, Chancy / Chifamba, Harunavamwe N / Divala, Titus / Lescano, Andres G / Majam, Mohammed / Mbo, Danjuma / Suwantika, Auliya A / Tovar, Marco A / Yadav, Pragya / Corbett, Elisabeth L / Vassall, Anna / Jit, Mark

    Research square

    2023  

    Abstract: Background: Rapid diagnostic testing may support improved treatment of COVID patients. Understanding COVID testing and care pathways is important for assessing the impact and cost-effectiveness of testing in the real world, yet there is limited ... ...

    Abstract Background: Rapid diagnostic testing may support improved treatment of COVID patients. Understanding COVID testing and care pathways is important for assessing the impact and cost-effectiveness of testing in the real world, yet there is limited information on these pathways in low-and-middle income countries (LMICs). We therefore undertook an expert consultation to better understand testing policies and practices, clinical screening, the profile of patients seeking testing or care, linkage to care after testing, treatment, lessons learnt and expected changes in 2023 in LMICs.
    Methods: We organized a qualitative consultation with ten experts from seven LMICs identified through purposive sampling. We conducted structured interviews during six regional consultations, and undertook a thematic analysis of the responses to our questions.
    Results: Participants reported that, after initial efforts to scale-up testing (which often encountered delays), the policy priority given to COVID testing has declined. Comorbidities putting patients at heightened risk (e.g., diabetes) mainly relied on self-identification. The decision to test following clinical screening was highly context- and location-specific, often dictated by local epidemiology and test availability. When rapid diagnostic tests were available, public sector healthcare providers tended to rely on them for diagnosis, while private sector providers predominantly used polymerase chain reaction (PCR) tests. Positive test results were generally taken at 'face value' by clinicians, although negative tests with a high index of suspicion may be confirmed with PCR. However, even with a positive result, patients were not always linked to care in a timely manner because of reluctance to receiving care or delays in returning to care centres upon clinical deterioration. Countries often lacked multiple components of the range of therapeutics advised in WHO guidelines: notably so for oral antivirals designed for high-risk mild patients. Severely ill patients mostly received corticosteroids and, in higher-resourced settings, tocilizumab.
    Conclusions: Testing does not always prompt enhanced care, due to reluctance on the part of patients and limited therapeutic availability within clinical settings. Any analysis of the impact or cost-effectiveness of testing policies post pandemic needs to either consider investment in optimal treatment pathways or constrain estimates of benefits based on actual practice.
    Language English
    Publishing date 2023-10-04
    Publishing country United States
    Document type Preprint
    DOI 10.21203/rs.3.rs-3384843/v1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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