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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    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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    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
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    Lower rates of ART initiation and decreased retention among ART-naïve patients who consume alcohol enrolling in HIV care and treatment programs in Kenya and Uganda
    (Public Library of Science, 2020-10-23) Patsis, Ioannis; Goodrich, Suzanne; Yiannoutsos, Constantin T.; Brown, Steven A.; Musick, Beverly S.; Diero, Lameck; Kulzer, Jayne L.; Bwana, Mwembesa Bosco; Oyaro, Patrick; Wools-Kaloustian, Kara K.; Biostatistics, School of Public Health
    Objectives Almost 13 million people are estimated to be on antiretroviral therapy in Eastern and Southern Africa, and their disease course and program effectiveness could be significantly affected by the concurrent use of alcohol. Screening for alcohol use may be important to assess the prevalence of alcohol consumption and its impact on patient and programmatic outcomes. Methods As part of this observational study, data on patient characteristics and alcohol consumption were collected on a cohort of 765 adult patients enrolling in HIV care in East Africa. Alcohol consumption was assessed with the AUDIT questionnaire at enrollment. Subjects were classified as consuming any alcohol (AUDIT score >0), hazardous drinkers (AUDIT score ≥8) and hyper drinkers (AUDIT score ≥16). The effects of alcohol consumption on retention in care, death and delays in antiretroviral therapy (ART) initiation were assessed through competing risk (Fine & Gray) models. Results Of all study participants, 41.6% consumed alcohol, 26.7% were classified as hazardous drinkers, and 16.0% as hyper drinkers. Depending on alcohol consumption classification, men were 3–4 times more likely to consume alcohol compared to women. Hazardous drinkers (median age 32.8 years) and hyper drinkers (32.7 years) were slightly older compared to non-hazardous drinkers (30.7 years) and non-hyper drinkers (30.8 years), (p-values = 0.014 and 0.053 respectively). Median CD4 at enrollment was 330 cells/μl and 16% were classified World Health Organization (WHO) stage 3 or 4. There was no association between alcohol consumption and CD4 count or WHO stage at enrollment. Alcohol consumption was associated with significantly lower probability of ART initiation (adjusted sub-distribution hazard ratio aSHR = 0.77 between alcohol consumers versus non-consumers; p-value = 0.008), and higher patient non-retention in care (aSHR = 1.77, p-value = 0.023). Discussion Alcohol consumption is associated with significant delays in ART initiation and reduced retention in care for patients enrolling in HIV care and treatment programs in East Africa. Consequently, interventions that target alcohol consumption may have a significant impact on the HIV care cascade.
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    A model for extending antiretroviral care beyond the rural health centre
    (Wiley, 2009) Wools-Kaloustian, Kara K.; Sidle, John E.; Selke, Henry M.; Vedanthan, Rajesh; Kemboi, Emmanuel K.; Boit, Lillian J.; Jebet, Viola T.; Carroll, Aaron E.; Tierney, William M.; Kimaiyo, Sylvester; Medicine, School of Medicine
    Background A major obstacle facing many lower-income countries in establishing and maintaining HIV treatment programmes is the scarcity of trained health care providers. To address this shortage, the World Health Organization has recommend task shifting to HIV-infected peers. Methods We designed a model of HIV care that utilizes HIV-infected patients, community care coordinators (CCCs), to care for their clinically stable peers with the assistance of preprogrammed personal digital assistants (PDAs). Rather than presenting for the standard of care, monthly clinic visits, in this model, patients were seen every three months in clinics and monthly by their CCCs in the community during the interim two months. This study was conducted in Kosirai Division, western Kenya, where eight of the 24 sub-locations (defined geographic areas) within the division were randomly assigned to the intervention with the remainder used as controls. Prior to entering the field, CCCs underwent intensive didactic training and mentoring related to the assessment and support of HIV patients, as well as the use of PDAs. PDAs were programmed with specific questions and to issue alerts if responses fell outside of pre-established parameters. CCCs were regularly evaluated in six performance areas. An impressionistic analysis on the transcripts from the monthly group meetings that formed the basis of the continuous feedback and quality improvement programme was used to assess this model. Results All eight of the assigned CCCs successfully passed their training and mentoring, entered the field and remained active for the two years of the study. On evaluation of the CCCs, 89% of their summary scores were documented as superior during Year 1 and 94% as superior during Year 2. Six themes emerged from the impressionistic analysis in Year 1: confidentiality and “community” disclosure; roles and responsibilities; logistics; clinical care partnership; antiretroviral adherence; and PDA issues. At the end of the trial, of those patients not lost to follow up, 64% (56 of 87) in the intervention and 52% (58 of 103) in the control group were willing to continue in the programme (p = 0.26). Conclusion We found that an antiretroviral treatment delivery model that shifted patient monitoring and antiretroviral dispensing tasks into the community by HIV-infected patients was both acceptable and feasible. Trial registration ClinicalTrials.gov ID NCT00371540