Browsing by Author "Duda, Stephany N."
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Item Age-specific mortality rate ratios in adolescents and youth aged 10–24 years living with perinatally versus nonperinatally acquired HIV(Wolters Kluwer, 2021) Desmonde, Sophie; Ciaranello, Andrea L.; Malateste, Karen; Musick, Beverly; Patten, Gabriela; Thien Vu, An; Edmonds, Andrew; Neilan, Anne M.; Duda, Stephany N.; Wools-Kaloustian, Kara; Davies, Mary-Ann; Leroy, Valériane; Biostatistics and Health Data Science, School of MedicineObjective: To measure mortality incidence rates and incidence rate ratios (IRR) in adolescents and youth living with perinatally acquired HIV (YPHIV) compared with those living with nonperinatally acquired HIV (YNPHIV), by region, by sex, and during the ages of 10-14, 15-19, and 20-24 years in IeDEA. Design and methods: All those with a confirmed HIV diagnosis, antiretroviral therapy (ART)-naive at enrollment, and who have post-ART follow-up while aged 10-24 years between 2004 and 2016 were included. We estimated post-ART mortality incidence rates and 95% confidence intervals (95% CI) per 100 person-years for YPHIV (enrolled into care <10 years of age) and YNPHIV (enrolled ≥10 years and <25 years). We estimate mortality IRRs in a negative binomial regression model, adjusted for sex, region time-varying age, CD4+ cell count at ART initiation (<350 cells/μl, ≥350 cells/μl, unknown), and time on ART (<12 and ≥12 months). Results: Overall, 104 846 adolescents and youth were included: 21 340 (20%) YPHIV (50% women) and 83 506 YNPHIV (80% women). Overall mortality incidence ratios were higher among YNPHIV (incidence ratio: 2.3/100 person-years; 95% CI: 2.2-2.4) compared with YPHIV (incidence ratio: 0.7/100 person-years; 95% CI: 0.7-0.8). Among adolescents aged 10-19 years, mortality was lower among YPHIV compared with YNPHIV (all IRRs <1, ranging from 0.26, 95% CI: 0.13-0.49 in 10-14-year-old boys in the Asia-Pacific to 0.51, 95% CI: 0.30-0.87 in 15-19-year-old boys in West Africa). Conclusion: We report substantial amount of deaths occurring during adolescence. Mortality was significantly higher among YNPHIV compared to YPHIV. Specific interventions including HIV testing and early engagement in care are urgently needed to improve survival among YNPHIV.Item Availability of screening and treatment for common mental disorders in HIV clinic settings: data from the global International epidemiology Databases to Evaluate AIDS (IeDEA) Consortium, 2016–2017 and 2020(Wiley, 2023) Parcesepe, Angela M.; Stockton, Melissa; Remch, Molly; Wester, C. William; Bernard, Charlotte; Ross, Jeremy; Haas, Andreas D.; Ajeh, Rogers; Althoff, Keri N.; Enane, Leslie; Pape, William; Minga, Albert; Kwobah, Edith; Tlali, Mpho; Tanuma, Junko; Nsonde, Dominique; Freeman, Aimee; Duda, Stephany N.; Nash, Denis; Lancaster, Kathryn; IeDEA Consortium; Pediatrics, School of MedicineIntroduction: Common mental disorders (CMDs) are highly prevalent among people with HIV. Integrating mental healthcare into HIV care may improve mental health and HIV treatment outcomes. We describe the reported availability of screening and treatment for depression, anxiety and post-traumatic stress disorder (PTSD) at global HIV treatment centres participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) Consortium in 2020 and changes in availability at sites in low- or middle-income countries (LMICs) between 2016/2017 and 2020. Methods: In 2020, 238 sites contributing individual-level data to the IeDEA Consortium and in 2016/2017 a stratified random sample of IeDEA sites in LMICs were eligible to participate in site surveys on the availability of screening and treatment for CMDs. We assessed trends over time for 68 sites across 27 LMICs that participated in both surveys. Results: Among the 238 sites eligible to participate in the 2020 site survey, 227 (95%) participated, and mental health screening and treatment data were available for 223 (98%) sites across 41 countries. A total of 95 sites across 29 LMICs completed the 2016/2017 survey. In 2020, 68% of sites were in urban settings, and 77% were in LMICs. Overall, 50%, 14% and 12% of sites reported screening with a validated instrument for depression, anxiety and PTSD, respectively. Screening plus treatment in the form of counselling was available for depression, anxiety and PTSD at 46%, 13% and 11% of sites, respectively. Screening plus treatment in the form of medication was available for depression, anxiety and PTSD at 36%, 11% and 8% of sites, respectively. Among sites that participated in both surveys, screening for depression was more commonly available in 2020 than 2016/2017 (75% vs. 59%, respectively, p = 0.048). Conclusions: Reported availability of screening for depression increased among this group of IeDEA sites in LMICs between 2016/2017 and 2020. However, substantial gaps persist in the availability of mental healthcare at HIV treatment sites across global settings, particularly in resource-constrained settings. Implementation of sustainable strategies to integrate mental health services into HIV care is needed.Item Brief Report: Pediatric Cancer Burden and Treatment Resources Within the Pediatric IeDEA Consortium(Wolters Kluwer, 2017-09-01) Brown, Steven A.; Abbas, Salma; Davies, Mary-Ann; Bunupuradah, Torsak; Sohn, Annette H.; Technau, Karl-Günter; Renner, Lorna; Leroy, Valériane; Edmonds, Andrew; Yotebieng, Marcel; McGowan, Catherine C.; Duda, Stephany N.; Mofenson, Lynne; Musick, Beverly; Wools-Kaloustian, Kara; Biostatistics, School of Public HealthINTRODUCTION: The incidence and treatment of cancer in HIV-infected children from resource-limited settings has not been extensively studied. OBJECTIVES: Develop and implement a cross-sectional survey to evaluate pediatric cancer burden, diagnostic modalities in use, and treatment availability as perceived by HIV clinic staff at regional International Epidemiology Databases to Evaluate AIDS (IeDEA) sites. METHODS: IeDEA regional investigators developed a cross-sectional clinical site survey which included questions on the numbers and types of pediatric cancers observed, modalities used to treat identified cancers, and treatment options available at individual sites in the Asia-Pacific, Latin America, Central Africa, East Africa, West Africa, and Southern Africa regions. RESULTS: Kaposi sarcoma, non-Hodgkin lymphoma, and Burkitt lymphoma were reported by site personnel to be the most prevalent types of cancer in the pediatric HIV population. Survey results indicate that access to comprehensive cancer treatment modalities is very limited for children in these regions despite HIV care and treatment sites reporting that they diagnose pediatric cancers. Responses also showed that evaluating cancer in the pediatric HIV population is a challenge due to a lack of resources and varying treatment availability within regions. CONCLUSIONS: Further study is needed to increase our understanding of the changing epidemiology of cancer in HIV-infected pediatric populations. Increased financial and technical resources are critical to aid in the advancement of health services to support treatment of these children in resource-constrained settings.Item Characteristics and comprehensiveness of adult HIV care and treatment programmes in Asia-Pacific, sub-Saharan Africa and the Americas: results of a site assessment conducted by the International epidemiologic Databases to Evaluate AIDS (IeDEA) Collaboration(International AIDS Society, 2014-12-15) Duda, Stephany N.; Farr, Amanda M.; Lindegren, Mary Lou; Blevins, Meredith; Wester, C. William; Wools-Kaloustian, Kara; Ekouevi, Didier K.; Eger, Matthias; Hemingway-Foda, Jennifer; Cooper, David A.; Moore, Richard D.; McGowan, Catherine C.; Nash, Denis; Department of Medicine, IU School of MedicineINTRODUCTION: HIV care and treatment programmes worldwide are transforming as they push to deliver universal access to essential prevention, care and treatment services to persons living with HIV and their communities. The characteristics and capacity of these HIV programmes affect patient outcomes and quality of care. Despite the importance of ensuring optimal outcomes, few studies have addressed the capacity of HIV programmes to deliver comprehensive care. We sought to describe such capacity in HIV programmes in seven regions worldwide. METHODS: Staff from 128 sites in 41 countries participating in the International epidemiologic Databases to Evaluate AIDS completed a site survey from 2009 to 2010, including sites in the Asia-Pacific region (n=20), Latin America and the Caribbean (n=7), North America (n=7), Central Africa (n=12), East Africa (n=51), Southern Africa (n=16) and West Africa (n=15). We computed a measure of the comprehensiveness of care based on seven World Health Organization-recommended essential HIV services. RESULTS: Most sites reported serving urban (61%; region range (rr): 33-100%) and both adult and paediatric populations (77%; rr: 29-96%). Only 45% of HIV clinics that reported treating children had paediatricians on staff. As for the seven essential services, survey respondents reported that CD4+ cell count testing was available to all but one site, while tuberculosis (TB) screening and community outreach services were available in 80 and 72%, respectively. The remaining four essential services - nutritional support (82%), combination antiretroviral therapy adherence support (88%), prevention of mother-to-child transmission (PMTCT) (94%) and other prevention and clinical management services (97%) - were uniformly available. Approximately half (46%) of sites reported offering all seven services. Newer sites and sites in settings with low rankings on the UN Human Development Index (HDI), especially those in the President's Emergency Plan for AIDS Relief focus countries, tended to offer a more comprehensive array of essential services. HIV care programme characteristics and comprehensiveness varied according to the number of years the site had been in operation and the HDI of the site setting, with more recently established clinics in low-HDI settings reporting a more comprehensive array of available services. Survey respondents frequently identified contact tracing of patients, patient outreach, nutritional counselling, onsite viral load testing, universal TB screening and the provision of isoniazid preventive therapy as unavailable services. CONCLUSIONS: This study serves as a baseline for on-going monitoring of the evolution of care delivery over time and lays the groundwork for evaluating HIV treatment outcomes in relation to site capacity for comprehensive care.Item Comprehensiveness of HIV care provided at global HIV treatment sites in the IeDEA consortium: 2009 and 2014(Wiley, 2017-01-06) Fritz, Cristin Q.; Blevins, Meridith; Lindegren, Mary Lou; Wools-Kaloutsian, Kara; Musick, Beverly S.; Cornell, Morna; Goodwin, Kelly; Addison, Dianne; Dusingize, Jean Claude; Messou, Eugène; Poda, Armel; Duda, Stephany N.; McGowan, Catherine C.; Law, Matthew G.; Moore, Richard D.; Freeman, Aimee; Nash, Denis; Wester, C. William; Medicine, School of MedicineINTRODUCTION: An important determinant of the effectiveness of HIV treatment programs is the capacity of sites to implement recommended services and identify systematic changes needed to ensure that invested resources translate into improved patient outcomes. We conducted a survey in 2014 of HIV care and treatment sites in the seven regions of the International epidemiologic Database to Evaluate AIDS (IeDEA) Consortium to evaluate facility characteristics, HIV prevention, care and treatment services provided, laboratory capacity, and trends in the comprehensiveness of care compared to data obtained in the 2009 baseline survey. METHODS: Clinical staff from 262 treatment sites in 45 countries in IeDEA completed a site survey from September 2014 to January 2015, including Asia-Pacific with Australia (n = 50), Latin America and the Caribbean (n = 11), North America (n = 45), Central Africa (n = 17), East Africa (n = 36), Southern Africa (n = 87), and West Africa (n = 16). For the 55 sites with complete data from both the 2009 and 2014 survey, we evaluated change in comprehensiveness of care. RESULTS: The majority of the 262 sites (61%) offered seven essential services (ART adherence, nutritional support, PMTCT, CD4+ cell count testing, tuberculosis screening, HIV prevention, and outreach). Sites that were publicly funded (64%), cared for adults and children (68%), low or middle Human Development Index (HDI) rank (68%, 68%), and received PEPFAR support (71%) were most often fully comprehensive. CD4+ cell count testing was universally available (98%) but only 62% of clinics offered it onsite. Approximately two-thirds (69%) of sites reported routine viral load testing (44-100%), with 39% having it onsite. Laboratory capacity to monitor antiretroviral-related toxicity and diagnose opportunistic infections varied widely by testing modality and region. In the subgroup of 55 sites with two surveys, comprehensiveness of services provided significantly increased across all regions from 2009 to 2014 (5.7 to 6.5, p < 0.001). CONCLUSION: The availability of viral load monitoring remains suboptimal and should be a focus for site capacity, particularly in East and Southern Africa, where the majority of those initiating on ART reside. However, the comprehensiveness of care provided increased over the past 5 years and was related to type of funding received (publicly funded and PEPFAR supported).Item Design and implementation of a global site assessment survey among HIV clinics participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium(Public Library of Science, 2023) Brazier, Ellen; Maruri, Fernanda; Wester, C. William; Musick, Beverly; Freeman, Aimee; Parcesepe, Angela; Hossmann, Stefanie; Christ, Benedikt; Kimmel, April; Humphrey, John; Freeman, Esther; Enane, Leslie A.; Lancaster, Kathryn E.; Ballif, Marie; Golub, Jonathan E.; Nash, Denis; Duda, Stephany N.; International epidemiology Databases to Evaluate AIDS (IeDEA) consortium; Medicine, School of MedicineIntroduction: Timely descriptions of HIV service characteristics and their evolution over time across diverse settings are important for monitoring the scale-up of evidence-based program strategies, understanding the implementation landscape, and examining service delivery factors that influence HIV care outcomes. Methods: The International epidemiology Databases to Evaluate AIDS (IeDEA) consortium undertakes periodic cross-sectional surveys on service availability and care at participating HIV treatment sites to characterize trends and inform the scientific agenda for HIV care and implementation science communities. IeDEA's 2020 general site assessment survey was developed through a consultative, 18-month process that engaged diverse researchers in identifying content from previous surveys that should be retained for longitudinal analyses and in developing expanded and new content to address gaps in the literature. An iterative review process was undertaken to standardize the format of new survey questions and align them with best practices in survey design and measurement and lessons learned through prior IeDEA site assessment surveys. Results: The survey questionnaire developed through this process included eight content domains covered in prior surveys (patient population, staffing and community linkages, HIV testing and diagnosis, new patient care, treatment monitoring and retention, routine HIV care and screening, pharmacy, record-keeping and patient tracing), along with expanded content related to antiretroviral therapy (differentiated service delivery and roll-out of dolutegravir-based regimens); mental health and substance use disorders; care for pregnant/postpartum women and HIV-exposed infants; tuberculosis preventive therapy; and pediatric/adolescent tuberculosis care; and new content related to Kaposi's sarcoma diagnostics, the impact of COVID-19 on service delivery, and structural barriers to HIV care. The survey was distributed to 238 HIV treatment sites in late 2020, with a 95% response rate. Conclusion: IeDEA's approach for site survey development has broad relevance for HIV research networks and other priority health conditions.Item Implications of COVID-19 for HIV Research: data sources, indicators, and longitudinal analyses(Wiley, 2020-10) Rebeiro, Peter F.; Duda, Stephany N.; Wools-Kaloustian, Kara K.; Nash, Denis; Althoff, Keri N.; Medicine, School of MedicineItem Integrating services for HIV and multidrug-resistant tuberculosis: A global cross-sectional survey among ART clinics in low- and middle-income countries(PLOS, 2022-03) Zürcher, Kathrin; Cox, Samyra R.; Ballif, Marie; Enane, Leslie A.; Marcy, Olivier; Yotebieng, Marcel; Reubenson, Gary; Imsanguan, Worarat; Otero, Larissa; Suryavanshi, Nishi; Duda, Stephany N.; Egger, Matthias; Tornheim, Jeffrey A.; Fenner, Lukas; International Epidemiology Databases to Evaluate AIDS (IeDEA); Pediatrics, School of MedicineTuberculosis (TB) is the leading cause of death among PLHIV and multidrug-resistant-TB (MDR-TB) is associated with high mortality. We examined the management for adult PLHIV coinfected with MDR-TB at ART clinics in lower income countries. Between 2019 and 2020, we conducted a cross-sectional survey at 29 ART clinics in high TB burden countries within the global IeDEA network. We used structured questionnaires to collect clinic-level data on the TB and HIV services and the availability of diagnostic tools and treatment for MDR-TB. Of 29 ART clinics, 25 (86%) were in urban areas and 19 (66%) were tertiary care clinics. Integrated HIV-TB services were reported at 25 (86%) ART clinics for pan-susceptible TB, and 14 (48%) clinics reported full MDR-TB services on-site, i.e. drug susceptibility testing [DST] and MDR-TB treatment. Some form of DST was available on-site at 22 (76%) clinics, while the remainder referred testing off-site. On-site DST for second-line drugs was available at 9 (31%) clinics. MDR-TB treatment was delivered on-site at 15 (52%) clinics, with 10 individualizing treatment based on DST results and five using standardized regimens alone. Bedaquiline was routinely available at 5 (17%) clinics and delamanid at 3 (10%) clinics. Although most ART clinics reported having integrated HIV and TB services, few had fully integrated MDR-TB services. There is a continued need for increased access to diagnostic and treatment options for MDR-TB patients and better integration of MDR-TB services into the HIV care continuum.Item International epidemiology databases to evaluate AIDS (IeDEA) in sub-Saharan Africa, 2012–2019(BMJ Publishing Group, 2020-05-15) Chammartin, Frédérique; Dao Ostinelli, Cam Ha; Anastos, Kathryn; Jaquet, Antoine; Brazier, Ellen; Brown, Steven; Dabis, Francois; Davies, Mary-Ann; Duda, Stephany N.; Malateste, Karen; Nash, Denis; Wools-Kaloustian, Kara; von Groote, Per M.; Egger, Matthias; Biostatistics, School of Public HealthPurpose: The objectives of the International epidemiology databases to evaluate AIDS (IeDEA) are to (i) evaluate the delivery of combination antiretroviral therapy (ART) in children, adolescents and adults in sub-Saharan Africa, (ii) to describe ART regimen effectiveness, durability and tolerability, (iii) to examine HIV-related comorbidities and coinfections and (iv) to examine the pregnancy-related and HIV-related outcomes of women on ART and their infants exposed to HIV or ART in utero or via breast milk. Participants: IeDEA is organised in four regions (Central, East, Southern and West Africa), with 240 treatment and care sites, six data centres at African, European and US universities, and almost 1.4 million children, adolescents and adult people living with HIV (PLWHIV) enrolled. Findings to date: The data include socio-demographic characteristics, clinical outcomes, opportunistic events, treatment regimens, clinic visits and laboratory measurements. They have been used to analyse outcomes in PLWHIV-1 or PLWHIV-2 who initiate ART, including determinants of mortality, of switching to second-line and third-line ART, drug resistance, loss to follow-up and the immunological and virological response to different ART regimens. Programme-level estimates of mortality have been corrected for loss to follow-up. We examined the impact of coinfection with hepatitis B and C, and the epidemiology of different cancers and of (multidrug resistant) tuberculosis, renal disease and of mental illness. The adoption of 'Treat All', making ART available to all PLWHIV regardless of CD4+ cell count or clinical stage was another important research topic. Future plans: IeDEA has formulated several research priorities for the 'Treat All' era in sub-Saharan Africa. It recently obtained funding to set up sentinel sites where additional data are prospectively collected on cardiometabolic risks factors as well as mental health and liver diseases, and is planning to create a drug resistance database.Item 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 MedicineIntroduction: 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.