Browsing by Author "Wools-Kaloustian, Kara K."

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    Association of Health Status and Nicotine Consumption with SARS-CoV-2 positivity rates
    (BMC, 2021-10) Duszynski, Thomas J.; Fadel, William; Wools-Kaloustian, Kara K.; Dixon, Brian E.; Yiannoutsos, Constantin; Halverson, Paul K.; Menachemi, Nir; Epidemiology, School of Public Health
    BACKGROUND: Much of what is known about COVID-19 risk factors comes from patients with serious symptoms who test positive. While risk factors for hospitalization or death include chronic conditions and smoking; less is known about how health status or nicotine consumption is associated with risk of SARS-CoV-2 infection among individuals who do not present clinically. METHODS: Two community-based population samples (including individuals randomly and nonrandomly selected for statewide testing, n = 8214) underwent SARS-CoV-2 testing in nonclinical settings. Each participant was tested for current (viral PCR) and past (antibody) infection in either April or June of 2020. Before testing, participants provided demographic information and self-reported health status and nicotine and tobacco behaviors (smoking, chewing, vaping/e-cigarettes). Using descriptive statistics and a bivariate logistic regression model, we examined the association between health status and use of tobacco or nicotine with SARS-CoV-2 positivity on either PCR or antibody tests. RESULTS: Compared to people with self-identified "excellent" or very good health status, those reporting "good" or "fair" health status had a higher risk of past or current infections. Positive smoking status was inversely associated with SARS-CoV-2 infection. Chewing tobacco was associated with infection and the use of vaping/e-cigarettes was not associated with infection. CONCLUSIONS: In a statewide, community-based population drawn for SARS-CoV-2 testing, we find that overall health status was associated with infection rates. Unlike in studies of COVID-19 patients, smoking status was inversely associated with SARS-CoV-2 positivity. More research is needed to further understand the nature of this relationship.
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    CD4 trajectory adjusting for dropout among HIV-positive patients receiving combination antiretroviral therapy in an East African HIV care centre
    (Wiley, 2014-08-14) Kiragga, Agnes N.; Lok, Judith J.; Musick, Beverly S.; Bosch, Ronald J.; Mwangi, Ann; Wools-Kaloustian, Kara K.; Yiannoutsos, Constantin T.; East Africa IeDEA Regional Consortium; Medicine, School of Medicine
    Objective: Estimates of CD4 response to antiretroviral therapy (ART) obtained by averaging data from patients in care, overestimate population CD4 response and treatment program effectiveness because they do not consider data from patients who are deceased or not in care. We use mathematical methods to assess and adjust for this bias based on patient characteristics. Design: We examined data from 25,261 HIV-positive patients from the East Africa IeDEA Consortium. Methods: We used inverse probability of censoring weighting (IPCW) to represent patients not in care by patients in care with similar characteristics. We address two questions: What would the median CD4 be "had everyone starting ART remained on observation?" and "were everyone starting ART maintained on treatment?" Results: Routine CD4 count estimates were higher than adjusted estimates even under the best-case scenario of maintaining all patients on treatment. Two years after starting ART, differences between estimates diverged from 30 cells/µL, assuming similar mortality and treatment access among dropouts as patients in care, to over 100 cells/µL assuming 20% lower survival and 50% lower treatment access among dropouts. When considering only patients in care, the proportion of patients with CD4 above 350 cells/µL was 50% adjusted to below 30% when accounting for patients not in care. One-year mortality diverged 6-14% from the naïve estimates depending on assumptions about access to care among lost patients. Conclusions: Ignoring mortality and loss to care results in over-estimation of ART response for patients starting treatment and exaggerates the efficacy of treatment programs administering it.
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    Clinical and programmatic outcomes of HIV-exposed infants enrolled in care at geographically diverse clinics, 1997-2021: A cohort study
    (Public Library of Science, 2022-09-15) Edmonds, Andrew; Brazier, Ellen; Musick, Beverly S.; Yotebieng, Marcel; Humphrey, John; Abuogi, Lisa L.; Adedimeji, Adebola; Keiser, Olivia; Msukwa, Malango; Carlucci, James G.; Maia, Marcelle; Pinto, Jorge A.; Leroy, Valériane; Davies, Mary-Ann; Wools-Kaloustian, Kara K.; IeDEA; Biostatistics, School of Public Health
    Background: Although 1·3 million women with HIV give birth annually, care and outcomes for HIV-exposed infants remain incompletely understood. We analyzed programmatic and health indicators in a large, multidecade global dataset of linked mother-infant records from clinics and programs associated with the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. Methods and findings: HIV-exposed infants were eligible for this retrospective cohort analysis if enrolled at <18 months at 198 clinics in 10 countries across 5 IeDEA regions: East Africa (EA), Central Africa (CA), West Africa (WA), Southern Africa (SA), and the Caribbean, Central, and South America network (CCASAnet). We estimated cumulative incidences of DNA PCR testing, loss to follow-up (LTFU), HIV diagnosis, and death through 24 months of age using proportional subdistribution hazard models accounting for competing risks. Competing risks were transfer, care withdrawal, and confirmation of negative HIV status, along with LTFU and death, when not the outcome of interest. In CA and EA, we quantified associations between maternal/infant characteristics and each outcome. A total of 82,067 infants (47,300 EA, 10,699 CA, 6,503 WA, 15,770 SA, 1,795 CCASAnet) born from 1997 to 2021 were included. Maternal antiretroviral therapy (ART) use during pregnancy ranged from 65·6% (CCASAnet) to 89·5% (EA), with improvements in all regions over time. Twenty-four-month cumulative incidences varied widely across regions, ranging from 12·3% (95% confidence limit [CL], 11·2%,13·5%) in WA to 94·8% (95% CL, 94·6%,95·1%) in EA for DNA PCR testing; 56·2% (95% CL, 55·2%,57·1%) in EA to 98·5% (95% CL, 98·3%,98·7%) in WA for LTFU; 1·9% (95% CL, 1·6%,2·3%) in WA to 10·3% (95% CL, 9·7%,10·9%) in EA for HIV diagnosis; and 0·5% (95% CL, 0·2%,1·0%) in CCASAnet to 4·7% (95% CL, 4·4%,5·0%) in EA for death. Although infant retention did not improve, HIV diagnosis and death decreased over time, and in EA, the cumulative incidence of HIV diagnosis decreased substantially, declining to 2·9% (95% CL, 1·5%,5·4%) in 2020. Maternal ART was associated with decreased infant mortality (subdistribution hazard ratio [sdHR], 0·65; 95% CL, 0·47,0·91 in EA, and sdHR, 0·51; 95% CL, 0·36,0·74 in CA) and HIV diagnosis (sdHR, 0·40; 95% CL, 0·31,0·50 in EA, and sdHR, 0·41; 95% CL, 0·31,0·54 in CA). Study limitations include potential misclassification of outcomes in real-world service delivery data and possible nonrepresentativeness of IeDEA sites and the population of HIV-exposed infants they serve. Conclusions: While there was marked regional and temporal heterogeneity in clinical and programmatic outcomes, infant LTFU was high across all regions and time periods. Further efforts are needed to keep HIV-exposed infants in care to receive essential services to reduce HIV infection and mortality.
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    Declining Tuberculosis Incidence Among People Receiving HIV Care and Treatment Services in East Africa, 2007–2012
    (Lippincott, Williams, and Wilkins, 2016-04) Saito, Suzue; Mpofu, Philani; Carter, E. Jane; Diero, Lameck; Wools-Kaloustian, Kara K.; Yiannoutsos, Constantin T.; Beverly, Musick S.; Tsiouris, Simon; Somi, Geoffrey R.; Ssali, John; Nash, Denis; Elul, Batya; Department of Medicine, IU School of Medicine
    Background: Antiretroviral therapy (ART) reduces the risk of Tuberculosis (TB) among people living with HIV (PLWH). With ART scale-up in sub-Saharan Africa over the past decade, incidence of TB among PLWH engaged in HIV care is predicted to decline. Methods: We conducted a retrospective analysis of routine clinical data from 168,330 PLWH receiving care at 35 facilities in Kenya, Tanzania, and Uganda during 2003–2012, participating in the East African region of the International Epidemiologic Databases to Evaluate AIDS. Temporal trends in facility-based annual TB incidence rates (per 100,000 person years) among PLWH and country-specific standardized TB incidence ratios using annual population-level TB incidence data from the World Health Organization were computed between 2007 and 2012. We examined patient-level and facility-level factors associated with incident TB using multivariable Cox models. Results: Overall, TB incidence rates among PLWH in care declined 5-fold between 2007 and 2012 from 5960 to 985 per 100,000 person years [P = 0.0003] (Kenya: 7552 to 1115 [P = 0.0007]; Tanzania: 7153 to 635 [P = 0.0025]; Uganda: 3204 to 242 [P = 0.018]). Standardized TB incidence ratios significantly decreased in the 3 countries, indicating a narrowing gap between incidence rates among PLWH and the general population. We observed lower hazards of incident TB among PLWH on ART and/or isoniazid preventive therapy and receiving care in facilities offering TB treatment onsite. Conclusions: Annual TB incidence rates among PLWH significantly declined during ART scale-up but remained higher than the general population. Increasing access to ART and isoniazid preventive therapy and co-location of HIV and TB treatment may further reduce TB incidence among PLWH.
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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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    Evaluating the Impact of a HIV Low-Risk Express Care Task-Shifting Program: A Case Study of the Targeted Learning Roadmap
    (Walter de Gruyter GmbH, 2016-12) Tran, Linh; Yiannoutsos, Constantin T.; Musick, Beverly S.; Wools-Kaloustian, Kara K.; Siika, Abraham; Kimaiyo, Sylvester; Laan, Mark J. van der; Petersen, Maya; Biostatistics, School of Public Health
    In conducting studies on an exposure of interest, a systematic roadmap should be applied for translating causal questions into statistical analyses and interpreting the results. In this paper we describe an application of one such roadmap applied to estimating the joint effect of both time to availability of a nurse-based triage system (low risk express care (LREC)) and individual enrollment in the program among HIV patients in East Africa. Our study population is comprised of 16,513 subjects found eligible for this task-shifting program within 15 clinics in Kenya between 2006 and 2009, with each clinic starting the LREC program between 2007 and 2008. After discretizing follow-up into 90-day time intervals, we targeted the population mean counterfactual outcome (i. e. counterfactual probability of either dying or being lost to follow up) at up to 450 days after initial LREC eligibility under three fixed treatment interventions. These were (i) under no program availability during the entire follow-up, (ii) under immediate program availability at initial eligibility, but non-enrollment during the entire follow-up, and (iii) under immediate program availability and enrollment at initial eligibility. We further estimated the controlled direct effect of immediate program availability compared to no program availability, under a hypothetical intervention to prevent individual enrollment in the program. Targeted minimum loss-based estimation was used to estimate the mean outcome, while Super Learning was implemented to estimate the required nuisance parameters. Analyses were conducted with the ltmle R package; analysis code is available at an online repository as an R package. Results showed that at 450 days, the probability of in-care survival for subjects with immediate availability and enrollment was 0.93 (95% CI: 0.91, 0.95) and 0.87 (95% CI: 0.86, 0.87) for subjects with immediate availability never enrolling. For subjects without LREC availability, it was 0.91 (95% CI: 0.90, 0.92). Immediate program availability without individual enrollment, compared to no program availability, was estimated to slightly albeit significantly decrease survival by 4% (95% CI 0.03,0.06, p<0.01). Immediately availability and enrollment resulted in a 7 % higher in-care survival compared to immediate availability with non-enrollment after 450 days (95% CI-0.08,-0.05, p<0.01). The results are consistent with a fairly small impact of both availability and enrollment in the LREC program on incare survival.
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    High Prevalence of Malaria Parasitemia and Anemia among Hospitalized Children in Rakai, Uganda
    (Public Library of Science, 2013-12-17) Kiggundu, Valerian L.; O’Meara, Wendy P.; Musoke, Richard; Nalugoda, Fred K.; Kigozi, Godfrey; Baghendaghe, Enos; Lutalo, Tom; Achienge, Marion K.; Reynolds, Steven J.; Makumbi, Fred; Serwadda, David; Gray, Ronald H.; Wools-Kaloustian, Kara K.; Medicine, School of Medicine
    Background: There is a paucity of data on malaria among hospitalized children in malaria endemic areas. We determined the prevalence, presentation and treatment outcomes of malaria and anemia among children in two hospitals in Rakai, Uganda. Methods: Children under five years hospitalized in Kalisizo hospital or Bikira health center in Rakai district, Uganda between May 2011 and May 2012 were enrolled and followed-up until discharge, death or referral. Data were collected on social-demographic characteristics, current and past illnesses and clinical signs and symptoms. Blood smears, hemoglobin (Hgb) levels and HIV testing were performed from finger/heel prick blood. The associations between malaria infection and other factors were estimated using log-binomial regression to estimate adjusted prevalence risk ratios (aPRR) and 95% confidence intervals (CIs), controlling for clustering at health facilities. Results: 2471 children were enrolled. The most common medical presentations were fever (96.2%), cough (61.7%), vomiting (44.2%), diarrhea (20.8%), and seizures (16.0%). The prevalence of malaria parasitemia was 54.6%. Children with malaria were more likely to present with a history of fever (aPRR 2.23; CI 1.18-4.24) and seizures (aPRR 1.12; CI 1.09-1.16). Confirmed malaria was significantly lower among girls than boys (aPRR 0.92; CI 0.91-0.93), HIV infected children (aPRR 0.60 CI 0.52-0.71), and children with diarrhea (aPRR 0.76; CI 0.65-0.90). The overall prevalence of anemia (Hgb<10 g/dl) was 56.3% and severe anemia (Hgb<6 g/dL) was 17.8%. Among children with severe anemia 76.8% had malaria parasitemia, of whom 93.1% received blood transfusion. Malaria associated mortality was 0.6%. Conclusion: There was a high prevalence of malaria parasitemia and anemia among inpatient children under five years. Malaria prevention is a priority in this population.
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    How Many SARS-CoV-2–Infected People Require Hospitalization? Using Random Sample Testing to Better Inform Preparedness Efforts
    (Wolters Kluwer, 2021) Menachemi, Nir; Dixon, Brian E.; Wools-Kaloustian, Kara K.; Yiannoutsos, Constantin T.; Halverson, Paul K.; Epidemiology, School of Public Health
    Context: Existing hospitalization ratios for COVID-19 typically use case counts in the denominator, which problematically underestimates total infections because asymptomatic and mildly infected persons rarely get tested. As a result, surge models that rely on case counts to forecast hospital demand may be inaccurately influencing policy and decision-maker action. Objective: Based on SARS-CoV-2 prevalence data derived from a statewide random sample (as opposed to relying on reported case counts), we determine the infection-hospitalization ratio (IHR), defined as the percentage of infected individuals who are hospitalized, for various demographic groups in Indiana. Furthermore, for comparison, we show the extent to which case-based hospitalization ratios, compared with the IHR, overestimate the probability of hospitalization by demographic group. Design: Secondary analysis of statewide prevalence data from Indiana, COVID-19 hospitalization data extracted from a statewide health information exchange, and all reported COVID-19 cases to the state health department. Setting: State of Indiana as of April 30, 2020. Main Outcome Measure(s): Demographic-stratified IHRs and case-hospitalization ratios. Results: The overall IHR was 2.1% and varied more by age than by race or sex. Infection-hospitalization ratio estimates ranged from 0.4% for those younger than 40 years to 9.2% for those older than 60 years. Hospitalization rates based on case counts overestimated the IHR by a factor of 10, but this overestimation differed by demographic groups, especially age. Conclusions: In this first study of the IHR based on population prevalence, our results can improve forecasting models of hospital demand—especially in preparation for the upcoming winter period when an increase in SARS CoV-2 infections is expected.
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    Implementation and Operational Research: Declining Tuberculosis Incidence Among People Receiving HIV Care and Treatment Services in East Africa, 2007-2012
    (Lippincott, Williams & Wilkins, 2016-04-01) Saito, Suzue; Mpofu, Philani; Carter, E. Jane; Diero, Lameck; Wools-Kaloustian, Kara K.; Yiannoutsos, Constantin T.; Musick, Beverly S.; Tsiouris, Simon; Somi, Geoffrey R.; Ssali, John; Nash, Denis; Elul, Batya; Biostatistics, School of Public Health
    Antiretroviral therapy (ART) reduces the risk of Tuberculosis (TB) among people living with HIV (PLWH). With ART scale-up in sub-Saharan Africa over the past decade, incidence of TB among PLWH engaged in HIV care is predicted to decline. METHODS: We conducted a retrospective analysis of routine clinical data from 168,330 PLWH receiving care at 35 facilities in Kenya, Tanzania, and Uganda during 2003-2012, participating in the East African region of the International Epidemiologic Databases to Evaluate AIDS. Temporal trends in facility-based annual TB incidence rates (per 100,000 person years) among PLWH and country-specific standardized TB incidence ratios using annual population-level TB incidence data from the World Health Organization were computed between 2007 and 2012. We examined patient-level and facility-level factors associated with incident TB using multivariable Cox models. RESULTS: Overall, TB incidence rates among PLWH in care declined 5-fold between 2007 and 2012 from 5960 to 985 per 100,000 person years [P = 0.0003] (Kenya: 7552 to 1115 [P = 0.0007]; Tanzania: 7153 to 635 [P = 0.0025]; Uganda: 3204 to 242 [P = 0.018]). Standardized TB incidence ratios significantly decreased in the 3 countries, indicating a narrowing gap between incidence rates among PLWH and the general population. We observed lower hazards of incident TB among PLWH on ART and/or isoniazid preventive therapy and receiving care in facilities offering TB treatment onsite. CONCLUSIONS: Annual TB incidence rates among PLWH significantly declined during ART scale-up but remained higher than the general population. Increasing access to ART and isoniazid preventive therapy and co-location of HIV and TB treatment may further reduce TB incidence among PLWH.
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    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 Medicine