Browsing by Author "Wagner Cardoso, Sandra"

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    Disparities in Dolutegravir Uptake Affecting Females of Reproductive Age With HIV in Low- and Middle-Income Countries After Initial Concerns About Teratogenicity : An Observational Study
    (American College of Physicians, 2022) Romo, Matthew L.; Patel, Rena C.; Edwards, Jessie K.; Humphrey, John M.; Musick, Beverly S.; Bernard, Caitlin; Maina, Mercy W.; Brazier, Ellen; Castelnuovo, Barbara; Penner, Jeremy; Wyka, Katarzyna; Wagner Cardoso, Sandra; Ly, Penh Sun; Kunzekwenyika, Cordelia; Cortés, Claudia P.; Panczak, Radoslaw; Kelvin, Elizabeth A.; Wools-Kaloustian, Kara K.; Nash, Denis; International epidemiology Databases to Evaluate AIDS (IeDEA); Medicine, School of Medicine
    Background: The transition to dolutegravir-containing antiretroviral therapy (ART) in low- and middle-income countries (LMICs) was complicated by an initial safety signal in May 2018 suggesting that exposure to dolutegravir at conception was possibly associated with infant neural tube defects. On the basis of additional evidence, in July 2019, the World Health Organization recommended dolutegravir for all adults and adolescents living with HIV. Objective: To describe dolutegravir uptake and disparities by sex and age group in LMICs. Design: Observational cohort study. Setting: 87 sites that began using dolutegravir in 11 LMICs in the Asia-Pacific; Caribbean, Central and South America network for HIV epidemiology (CCASAnet); and sub-Saharan African regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. Patients: 134 672 patients aged 16 years or older who received HIV care from January 2017 through March 2020. Measurements: Sex, age group, and dolutegravir uptake (that is, newly initiating ART with dolutegravir or switching to dolutegravir from another regimen). Results: Differences in dolutegravir uptake among females of reproductive age (16 to 49 years) emerged after the safety signal. By the end of follow-up, the cumulative incidence of dolutegravir uptake among females 16 to 49 years old was 29.4% (95% CI, 29.0% to 29.7%) compared with 57.7% (CI, 57.2% to 58.3%) among males 16 to 49 years old. This disparity was greater in countries that began implementing dolutegravir before the safety signal and initially had highly restrictive policies versus countries with a later rollout. Dolutegravir uptake was similar among females and males aged 50 years or older. Limitation: Follow-up was limited to 6 to 8 months after international guidelines recommended expanding access to dolutegravir. Conclusion: Substantial disparities in dolutegravir uptake affecting females of reproductive age through early 2020 are documented. Although this disparity was anticipated because of country-level restrictions on access, the results highlight its extent and initial persistence.
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    Lessons learned from over a decade of data audits in international observational HIV cohorts in Latin America and East Africa
    (Cambridge University Press, 2023-11-03) Lotspeich, Sarah C.; Shepherd, Bryan E.; Kariuk, Marion Achieng; Wools-Kaloustian, Kara; McGowan, Catherine C.; Musick, Beverly; Semeere, Aggrey; Crabtree Ramírez, Brenda E.; Mkwashapi, Denna M.; Cesar, Carina; Ssemakadde, Matthew; Machado, Daisy Maria; Ngeresa, Antony; Ferreira, Flávia Faleiro; Lwali, Jerome; Marcelin, Adias; Wagner Cardoso, Sandra; Luque, Marco Tulio; Otero, Larissa; Cortés, Claudia P.; Duda, Stephany N.; Medicine, School of Medicine
    Introduction: Routine patient care data are increasingly used for biomedical research, but such "secondary use" data have known limitations, including their quality. When leveraging routine care data for observational research, developing audit protocols that can maximize informational return and minimize costs is paramount. Methods: For more than a decade, the Latin America and East Africa regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium have been auditing the observational data drawn from participating human immunodeficiency virus clinics. Since our earliest audits, where external auditors used paper forms to record audit findings from paper medical records, we have streamlined our protocols to obtain more efficient and informative audits that keep up with advancing technology while reducing travel obligations and associated costs. Results: We present five key lessons learned from conducting data audits of secondary-use data from resource-limited settings for more than 10 years and share eight recommendations for other consortia looking to implement data quality initiatives. Conclusion: After completing multiple audit cycles in both the Latin America and East Africa regions of the IeDEA consortium, we have established a rich reference for data quality in our cohorts, as well as large, audited analytical datasets that can be used to answer important clinical questions with confidence. By sharing our audit processes and how they have been adapted over time, we hope that others can develop protocols informed by our lessons learned from more than a decade of experience in these large, diverse cohorts.