Browsing by Author "Wools-Kaloustian, Kara"

Now showing 1 - 10 of 28
  • Thumbnail Image
    Item
    547. A Retrospective Cohort Study of Treatment Patterns and Clinical Outcomes in Patients with COVID-19
    (Oxford, 2020-10) Pritchard, Haley; Hiles, Jon; Teresa, Batteiger; Desai, Armisha; Wrin, Justin E; Hlavaty, Ariel; Agard, Amanda; Hinton, Bradley; Lucky, Christine W; Fleming, Elizabeth; Khan, Humaira; Bomkamp, John P; Derringer, Jon; Schneider, Jack; Ryder, Jonathan; Russ, Jason D; Khan, Haseeba; Kleyman, Svetlana; Enane, Leslie A; Stack, Matthew; Kussin, Michelle L; Myers, Courtney; Nagy, Allysa; Richardson, Noah; Elsheikh, Omar; Rahman, Omar; Kruer, Rachel; Trigonis, Russell; Butt, Saira; Bhumbra, Samina; Kapil, Sasha; Abi-Mansour, Tanya; Howe, Zachary; Abdallah, Wassim; Gupta, Samir; Wools-Kaloustian, Kara; Medicine, School of Medicine
  • Thumbnail Image
    Item
    Achieving UNAIDS 90-90-90 targets for pregnant and postpartum women in sub-Saharan Africa: progress, gaps and research needs
    (Mediscript, 2018-11-15) Abuogi, Lisa L.; Humphrey, John M.; Mpody, Christian; Yotebieng, Marcel; Murnane, Pamela M.; Clouse, Kate; Otieno, Lindah; Cohen, Craig R.; Wools-Kaloustian, Kara; Medicine, School of Medicine
    The implementation of the 2013 World Health Organization Option B+ recommendations for HIV treatment during pregnancy has helped drive significant progress in achieving universal treatment for pregnant and postpartum women in sub-Saharan Africa (SSA). Yet, critical research and implementation gaps exist in achieving the UNAIDS 90-90-90 targets. To help guide researchers, programmers and policymakers in prioritising these areas, we undertook a comprehensive review of the progress, gaps and research needs to achieve the 90-90-90 targets for this population in the Option B+ era, including early infant HIV diagnosis (EID) for HIV-exposed infants. Salient areas where progress has been achieved or where gaps remain include: (1) knowledge of HIV status is higher among people with HIV in southern and eastern Africa compared to western and central Africa (81% versus 48%, UNAIDS); (2) access to antiretroviral therapy (ART) for pregnant women has doubled in 22 of 42 SSA countries, but only six have achieved the second 90, and nearly a quarter of pregnant women initiating ART become lost to follow-up; (3) viral suppression data for this population are sparse (estimates range from 30% to 98% peripartum), with only half of women maintaining suppression through 12 months postpartum; and (4) EID rates range from 15% to 62%, with only three of 21 high-burden SSA countries testing >50% HIV-exposed infants within the first 2 months of life. We have identified and outlined promising innovations and research designed to address these gaps and improve the health of pregnant and postpartum women living with HIV and their infants.
  • Thumbnail Image
    Item
    Assessing the impact of a primary care electronic medical record system in three Kenyan rural health centers
    (Oxford University Press, 2016-05) Tierney, William M.; Sidle, John E.; Diero, Lameck O.; Sudoi, Allan; Kiplagat, Jepchirchir; Macharia, Stephen; Shen, Changyu; Yeung, Ada; Were, Martin C.; Slaven, James E.; Wools-Kaloustian, Kara; Medicine, School of Medicine
    Objective: Efficient, effective health care requires rapid availability of patient information. We designed, implemented, and assessed the impact of a primary care electronic medical record (EMR) in three rural Kenyan health centers. Method: Local clinicians identified data required for primary care and public health reporting. We designed paper encounter forms to capture these data in adult medicine, pediatric, and antenatal clinics. Encounter form data were hand-entered into a new primary care module in an existing EMR serving onsite clinics serving patients infected with the human immunodeficiency virus (HIV). Before subsequent visits, Summary Reports were printed containing selected patient data with reminders for needed HIV care. We assessed effects on patient flow and provider work with time-motion studies before implementation and two years later, and we surveyed providers' satisfaction with the EMR. Results: Between September 2008 and December 2011, 72 635 primary care patients were registered and 114 480 encounter forms were completed. During 2011, 32 193 unique patients visited primary care clinics, and encounter forms were completed for all visits. Of 1031 (3.2%) who were HIV-infected, 85% received HIV care. Patient clinic time increased from 37 to 81 min/visit after EMR implementation in one health center and 56 to 106 min/visit in the other. However, outpatient visits to both health centers increased by 85%. Three-quarters of increased time was spent waiting. Despite nearly doubling visits, there was no change in clinical officers' work patterns, but the nurses' and the clerks' patient care time decreased after EMR implementation. Providers were generally satisfied with the EMR but desired additional training. Conclusions: We successfully implemented a primary care EMR in three rural Kenyan health centers. Patient waiting time was dramatically lengthened while the nurses' and the clerks' patient care time decreased. Long-term use of EMRs in such settings will require changes in culture and workflow.
  • Thumbnail Image
    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 Health
    INTRODUCTION: 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.
  • Thumbnail Image
    Item
    Cervical cancer data and data systems in limited-resource settings: Challenges and opportunities
    (Wiley, 2017-07) Drummond, Jennifer L.; Were, Martin C.; Arrossi, Silvina; Wools-Kaloustian, Kara; Medicine, School of Medicine
    Appropriate collection and use of health information is critical to the planning, scaling up, and improvement of cervical cancer programs. The health information systems implementation landscape is unique to each country; however, systems serving cervical cancer programs in low-resource settings share characteristics that present common challenges. In response, many programs have taken innovative approaches to generating the quality information needed for decision making. Recent advances in health information technology also provide feasible solutions to challenges. This article draws from the experiences of the authors and from current literature to describe outstanding challenges and promising practices in the implementation of cervical cancer data systems, and to make recommendations for next steps. Recommendations include engaging all stakeholders—including providers, program managers, implementing partners, and donors—in promoting national, district, and community information systems; building on existing systems and processes, as well as introducing new technologies; and evolving data collection and data systems as programs advance.
  • Thumbnail Image
    Item
    Changes in rapid HIV treatment initiation after national “treat all” policy adoption in 6 sub-Saharan African countries: Regression discontinuity analysis
    (PLOS, 2019-06-10) Tymejczyk, Olga; Brazier, Ellen; Yiannoutsos, Constantin T.; Vinikoor, Michael; van Lettow, Monique; Nalugoda, Fred; Urassa, Mark; Sinayobye, Jean d’Amour; Rebeiro, Peter F.; Wools-Kaloustian, Kara; Davies, Mary-Ann; Zaniewski, Elizabeth; Anderegg, Nanina; Liu, Grace; Ford, Nathan; Nash, Denis; Biostatistics, School of Public Health
    BACKGROUND: Most countries have formally adopted the World Health Organization's 2015 recommendation of universal HIV treatment ("treat all"). However, there are few rigorous assessments of the real-world impact of treat all policies on antiretroviral treatment (ART) uptake across different contexts. METHODS AND FINDINGS: We used longitudinal data for 814,603 patients enrolling in HIV care between 1 January 2004 and 10 July 2018 in 6 countries participating in the global International epidemiology Databases to Evaluate AIDS (IeDEA) consortium: Burundi (N = 11,176), Kenya (N = 179,941), Malawi (N = 84,558), Rwanda (N = 17,396), Uganda (N = 96,286), and Zambia (N = 425,246). Using a quasi-experimental regression discontinuity design, we assessed the change in the proportion initiating ART within 30 days of enrollment in HIV care (rapid ART initiation) after country-level adoption of the treat all policy. A modified Poisson model was used to identify factors associated with failure to initiate ART rapidly under treat all. In each of the 6 countries, over 60% of included patients were female, and median age at enrollment ranged from 32 to 36 years. In all countries studied, national adoption of treat all was associated with large increases in rapid ART initiation. Significant increases in rapid ART initiation immediately after treat all policy adoption were observed in Rwanda, from 44.4% to 78.9% of patients (34.5 percentage points [pp], 95% CI 27.2 to 41.7; p < 0.001), Kenya (25.7 pp, 95% CI 21.8 to 29.5; p < 0.001), Burundi (17.7 pp, 95% CI 6.5 to 28.9; p = 0.002), and Malawi (12.5 pp, 95% CI 7.5 to 17.5; p < 0.001), while no immediate increase was observed in Zambia (0.4 pp, 95% CI -2.9 to 3.8; p = 0.804) and Uganda (-4.2 pp, 95% CI -9.0 to 0.7; p = 0.090). The rate of rapid ART initiation accelerated sharply following treat all policy adoption in Malawi, Uganda, and Zambia; slowed in Kenya; and did not change in Rwanda and Burundi. In post hoc analyses restricted to patients enrolling under treat all, young adults (16-24 years) and men were at increased risk of not rapidly initiating ART (compared to older patients and women, respectively). However, rapid ART initiation following enrollment increased for all groups as more time elapsed since treat all policy adoption. Study limitations include incomplete data on potential ART eligibility criteria, such as clinical status, pregnancy, and enrollment CD4 count, which precluded the assessment of rapid ART initiation specifically among patients known to be eligible for ART before treat all. CONCLUSIONS: Our analysis indicates that adoption of treat all policies had a strong effect on increasing rates of rapid ART initiation, and that these increases followed different trajectories across the 6 countries. Young adults and men still require additional attention to further improve rapid ART initiation.
  • Thumbnail Image
    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 Medicine
    INTRODUCTION: 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.
  • Thumbnail Image
    Item
    Cost-effectiveness of first-line antiretroviral therapy for HIV-infected African children less than 3 years of age
    (Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2015-06-19) Ciaranello, Andrea L.; Doherty, Kathleen; Penazzato, Martina; Lindsey, Jane C.; Harrison, Linda; Kelly, Kathleen; Walensky, Rochelle P.; Essajee, Shaffiq; Losina, Elena; Muhe, Lulu; Wools-Kaloustian, Kara; Ayaya, Samuel; Weinstein, Milton C.; Palumbo, Paul; Freedberg, Kenneth A.; Department of Medicine, IU School of Medicine
    BACKGROUND: The International Maternal, Pediatric, and Adolescent Clinical Trials P1060 trial demonstrated superior outcomes for HIV-infected children less than 3 years old initiating antiretroviral therapy (ART) with lopinavir/ritonavir compared to nevirapine, but lopinavir/ritonavir is four-fold costlier. DESIGN/METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model, with published and P1060 data, to project outcomes under three strategies: no ART; first-line nevirapine (with second-line lopinavir/ritonavir); and first-line lopinavir/ritonavir (second-line nevirapine). The base-case examined South African children initiating ART at age 12 months; sensitivity analyses varied all key model parameters. Outcomes included life expectancy, lifetime costs, and incremental cost-effectiveness ratios [ICERs; dollars/year of life saved ($/YLS)]. We considered interventions with ICERs less than 1× per-capita gross domestic product (South Africa: $7500)/YLS as 'very cost-effective,' interventions with ICERs below 3× gross domestic product/YLS as 'cost-effective,' and interventions leading to longer life expectancy and lower lifetime costs as 'cost-saving'. RESULTS: Projected life expectancy was 2.8 years with no ART. Both ART regimens markedly improved life expectancy and were very cost-effective, compared to no ART. First-line lopinavir/ritonavir led to longer life expectancy (28.8 years) and lower lifetime costs ($41 350/person, from lower second-line costs) than first-line nevirapine (27.6 years, $44 030). First-line lopinavir/ritonavir remained cost-saving or very cost-effective compared to first-line nevirapine unless: liquid lopinavir/ritonavir led to two-fold higher virologic failure rates or 15-fold greater costs than in the base-case, or second-line ART following first-line lopinavir/ritonavir was very ineffective. CONCLUSIONS: On the basis of P1060 data, first-line lopinavir/ritonavir leads to longer life expectancy and is cost-saving or very cost-effective compared to first-line nevirapine. This supports WHO guidelines, but increasing access to pediatric ART is critical regardless of the regimen used.
  • Thumbnail Image
    Item
    Development, Assessment, and Outcomes of a Community-Based Model of Antiretroviral Care in Western Kenya Through a Cluster-Randomized Control Trial
    (Wolters Kluwer, 2021-06-01) Goodrich, Suzanne; Siika, Abraham; Mwangi, Ann; Nyambura, Monicah; Naanyu, Violet; Yiannoutsos, Constantin; Spira, Thomas; Bateganya, Moses; Toroitich-Ruto, Cathy; Otieno-Nyunya, Boaz; Wools-Kaloustian, Kara; Medicine, School of Medicine
    Objective: To develop and assess an alternative care model using community-based groups for people living with HIV and facilitate by lay personnel. Methods: Geographic locations in the Academic Model Providing Access to Healthcare Kitale clinic catchment were randomized to standard of care versus a community-based care group (ART Co-op). Adults stable on antiretroviral therapy and virally suppressed were eligible. Research Assistant-led ART Co-ops met in the community every 3 months. Participants were seen in the HIV clinic only if referred. CD4 count and viral load were measured in clinic at enrollment and after 12 months. Retention, viral suppression, and clinic utilization were compared between groups using χ2, Fisher exact, and Wilcoxon rank sum tests. Results: At 12 months, there were no significant differences in mean CD4 count or viral load suppression. There was a significant difference in patient retention in assigned study group between the intervention and control group (81.6% vs 98.6%; P < 0.001), with a number of intervention patients withdrawing because of stigma, relocation, pregnancy, and work conflicts. All participants, however, were retained in an HIV care program for the study duration. The median number of clinic visits was lower for the intervention group than that for the control group (0 vs 3; P < 0.001). Conclusions: Individuals retained in a community-based HIV care model had clinical outcomes equivalent to those receiving clinic-based care. This innovative model of HIV care addresses the problems of insufficient health care personnel and patient retention barriers, including time, distance, and cost to attend clinic, and has the potential for wider implementation.
  • Thumbnail Image
    Item
    Facility-Level Factors Influencing Retention of Patients in HIV Care in East Africa
    (Plos, 2016-08-10) Rachlis, Beth; Bakoyannis, Giorgos; Easterbrook, Philippa; Genberg, Becky; Braithwaite, Scott; Cohen, Craig R.; Bukusi, Elizabeth A.; Kambugu, Andrew; Bwana, Mwebesa Bosco; Somi, Geoffrey R.; Geng, Elvin H.; Musick, Beverly; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Braitstein, Paula; Department of Biostatistics, Richard M. Fairbanks School of Public Health
    Losses to follow-up (LTFU) remain an important programmatic challenge. While numerous patient-level factors have been associated with LTFU, less is known about facility-level factors. Data from the East African International epidemiologic Databases to Evaluate AIDS (EA-IeDEA) Consortium was used to identify facility-level factors associated with LTFU in Kenya, Tanzania and Uganda. Patients were defined as LTFU if they had no visit within 12 months of the study endpoint for pre-ART patients or 6 months for patients on ART. Adjusting for patient factors, shared frailty proportional hazard models were used to identify the facility-level factors associated with LTFU for the pre- and post-ART periods. Data from 77,362 patients and 29 facilities were analyzed. Median age at enrolment was 36.0 years (Interquartile Range: 30.1, 43.1), 63.9% were women and 58.3% initiated ART. Rates (95% Confidence Interval) of LTFU were 25.1 (24.7-25.6) and 16.7 (16.3-17.2) per 100 person-years in the pre-ART and post-ART periods, respectively. Facility-level factors associated with increased LTFU included secondary-level care, HIV RNA PCR turnaround time >14 days, and no onsite availability of CD4 testing. Increased LTFU was also observed when no nutritional supplements were provided (pre-ART only), when TB patients were treated within the HIV program (pre-ART only), and when the facility was open ≤4 mornings per week (ART only). Our findings suggest that facility-based strategies such as point of care laboratory testing and separate clinic spaces for TB patients may improve retention.