Browsing by Author "Vinikoor MJ"
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Item A new approach to prevent, diagnose, and treat hepatitis B in Africa.(2023) Spearman CW; Andersson MI; Bright B; Davwar PM; Desalegn H; Guingane AN; Johannessen A; Kabagambe K; Lemoine M; Matthews PC; Ndow G; Riches N; Shimakawa Y; Sombié R; Stockdale AJ; Taljaard JJ; Vinikoor MJ; Wandeler G; Okeke E; Sonderup M; School of Medicine, University of Alabama at Birmingham, Birmingham, AL USA.; Malawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.; LiveWell Initiative, Yesuf Abiodun Street, Victoria Island, Lagos, Nigeria.; Department of Metabolism, Digestion and Reproduction, Division of Digestive Diseases, Imperial College London, London, UK.; Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, The Gambia.; Department of Internal Medicine, Jos Univeristy Teaching Hospital, Jos, Nigeria.; Radcliffe Department of Medicine, University of Oxford, Oxford, UK.; Division of Medical Virology, University of Stellenbosch, Stellenbosch, South Africa.; Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, Paris, France.; The National Organisation for People Living With Hepatitis B, Kampala, Uganda.; Department of Infectious Diseases, Vestfold Hospital Trust, Tønsberg, Norway.; School of Medicine, University of Zambia, Lusaka, Zambia.; Division of Infection and Immunity, University College London, Gower Street, London, WC1E 6BT UK.; Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.; Service d'hépato-Gastroentérologie, CHU Yalgado OUÉDRAOGO, Université Joseph KI-ZERBO, Ouagadougou, Burkina Faso.; Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.; The Francis Crick Institute, 1 Midland Road, London, NW1 1AT UK.; Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.; Department of Internal Medicine, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.; Department of Infectious Diseases, University College London Hospital, Euston Road, London, NW1 2BU UK.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Division of Infectious Diseases, Department of Medicine, Tygerberg Hospital and Stellenbosch University, Cape Town, South Africa.; Women in Hepatitis Africa, Womens Wellness Center for Hepatitis, Isale Ajoke, Iwaya-Makoko, Lagos State, Nigeria.; Department of Medicine, Jos University Teaching Hospital, Jos, Nigeria.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.; Hepato-Gastroenterology Department, Bogodogo University Hospital Center, Ouagadougou, Burkina Faso.; Department of Clinical Infection, Microbiology and Immunity, University of Liverpool, Liverpool, UK.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)There are 82 million people living with hepatitis B (PLWHB) in the World Health Organization Africa region, where it is the main cause of liver disease. Effective vaccines have been available for over 40 years, yet there are 990,000 new infections annually, due to limited implementation of hepatitis B birth dose vaccination and antenatal tenofovir prophylaxis for highly viraemic women, which could eliminate mother-to-child transmission. Despite effective and cheap antiviral treatment which can suppress hepatitis B virus replication and reduce the risk of hepatocellular carcinoma (HCC), < 2% of PLWHB are diagnosed, and only 0.1% are treated. As a result, PLWHB are frequently diagnosed only when they have already developed decompensated cirrhosis and late-stage HCC, and consequently 80,000 hepatitis B-associated deaths occur each year. Major barriers include complex treatment guidelines which were derived from high-income settings, lack of affordable diagnostics, lack or insufficient domestic funding for hepatitis care, and limited healthcare infrastructure. Current treatment criteria may overlook patients at risk of cirrhosis and HCC. Therefore, expanded and simplified treatment criteria are needed. We advocate for decentralized community treatment programmes, adapted for low-resource and rural settings with limited laboratory infrastructure. We propose a strategy of treat-all except patients fulfilling criteria that suggest low risk of disease progression. Expanded treatment represents a financial challenge requiring concerted action from policy makers, industry, and international donor agencies. It is crucial to accelerate hepatitis B elimination plans, integrate hepatitis B care into existing healthcare programmes, and prioritize longitudinal and implementation research to improve care for PLWHB.Item Absence of Active Hepatitis C Virus Infection in Human Immunodeficiency Virus Clinics in Zambia and Mozambique.(2016-Mar) Wandeler G; Mulenga L; Hobbins M; Joao C; Sinkala E; Hector J; Aly M; Chi BH; Egger M; Vinikoor MJ; Department of Infectious Diseases, Bern University Hospital; Institute of Social and Preventive Medicine, University of Bern, Switzerland; Department of Infectious Diseases, University of Dakar, Senegal.; School of Medicine, Department of Medicine, University of Zambia, Lusaka; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham.; School of Medicine, Department of Medicine, University of Zambia, Lusaka; Department of Medicine, University Teaching Hospital, Lusaka, Zambia.; Nucleo de Investigação Operacional, Pemba , Mozambique.; SolidarMed , Ancuabe, Mozambique, Lucerne , Switzerland.; Institute of Social and Preventive Medicine, University of Bern, Switzerland; Centre for Infectious Disease Epidemiology and Research, University of Cape Town, South Africa.; Department of Obstetrics and Gynecology , University of North Carolina at Chapel Hill.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Few studies have evaluated the prevalence of replicating hepatitis C virus (HCV) infection in sub-Saharan Africa. Among 1812 individuals infected with human immunodeficiency virus, no patient in rural Mozambique and 4 patients in urban Zambia were positive for anti-HCV antibodies. Of these, none had confirmed HCV replication.Item Advanced HIV disease during the 'Treat All' era in Botswana.(2020-Dec-01) Vinikoor MJ; Hachaambwa L; Center for International Health, Education, and Biosecurity.; Division of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.; Centre for Infectious Disease Research in Zambia.; Division of Infectious Diseases, Department of Medicine, University of Zambia School of Medicine, Lusaka, Zambia.; Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Item Age at antiretroviral therapy initiation predicts immune recovery, death, and loss to follow-up among HIV-infected adults in urban Zambia.(2014-Oct) Vinikoor MJ; Joseph J; Mwale J; Marx MA; Goma FM; Mulenga LB; Stringer JS; Eron JJ; Chi BH; 1 Centre for Infectious Disease Research in Zambia , Lusaka, Zambia .; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)We analyzed the association of age at antiretroviral therapy (ART) initiation with CD4(+) T cell count recovery, death, and loss to follow-up (LTFU) among HIV-infected adults in Zambia. We compared baseline characteristics of patients by sex and age at ART initiation [categorized as 16-29 years, 30-39 years, 40-49 years, 50-59 years, and 60 years and older]. We used the medication possession ratio to assess adherence and analysis of covariance to measure the adjusted change in CD4(+) T cell count during ART. Using Cox proportional hazard regression, we examined the association of age with death and LTFU. In a secondary analysis, we repeated models with age as a continuous variable. Among 92,130 HIV-infected adults who initiated ART, the median age was 34 years and 6,281 (6.8%) were aged ≥50 years. Compared with 16-29 year olds, 40-49 year olds (-46 cells/mm(3)), 50-59 year olds (-53 cells/mm(3)), and 60+ year olds (-60 cells/mm(3)) had reduced CD4(+) T cell gains during ART. The adjusted hazard ratio (AHR) for death was increased for individuals aged ≥40 years (AHR 1.25 for 40-49 year olds, 1.56 for 50-59 year olds, and 2.97 for 60+ year olds). Adherence and retention in care were poorest among 16-29 year olds but similar in other groups. As a continuous variable, a 5-year increase in age predicted reduced CD4(+) T cell count recovery and increased risk of death. Increased age at ART initiation was associated with poorer clinical outcomes, while age <30 years was associated with a higher likelihood of being lost to follow-up. HIV treatment guidelines should consider age-specific recommendations.Item Alcohol reduction outcomes following brief counseling among adults with HIV in Zambia: A sequential mixed methods study.(2022) Asombang M; Helova A; Chipungu J; Sharma A; Wandeler G; Kane JC; Turan JM; Smith H; Vinikoor MJ; Department of Infectious Diseases and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Columbia University Mailman School of Public Health, New York City, NY, United States of America.; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States of America.; Bradford Institute for Health Research, Bradford, United Kingdom.; School of Public Health, University of Alabama at Birmingham, Birmingham, AL, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Data from sub-Saharan Africa on the impact of alcohol on the HIV epidemic in sub-Saharan Africa is limited. In this region, it is not well understood how people with HIV (PLWHA) respond to alcohol reduction counseling while they are linked to HIV clinical care. We conducted an explanatory sequential mixed-methods study to understand patterns of alcohol use among adults (18+ years) within a prospective HIV cohort at two urban public-sector clinics in Zambia. At antiretroviral therapy (ART) start and one year later, we measured alcohol use with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and those reporting any alcohol use were provided brief counseling. We conducted focus groups at 1 year with participants who had any alcohol use and 20 in-depth interviews among the subgroup with unhealthy use pre-ART and who either reduced or did not reduce their use by 1 year to moderate levels or abstinence. Focus group Discussions (FGDs) (n = 2) were also held with HIV clinic staff. Qualitative data were analyzed using thematic analysis. The data obtained from 693 participants was analyzed (median age 34 years, 45% men), it revealed that unhealthy alcohol use (AUDIT-C >3 for men; >2 for women) was reported among 280 (40.4%) at baseline and 205 (29.6%) at 1 year on ART. Reduction from unhealthy to moderate use or abstinence was more common with older age, female, non-smoking, and at Clinic B (all P<0.05). Qualitative data revealed ineffective alcohol support at clinics, social pressures in the community to consume alcohol, and unaddressed drivers of alcohol use including poverty, poor health status, depression, and HIV stigma. Healthcare workers reported a lack of training in alcohol screening and treatment, which led to mixed messages provided to patients ('reduce to safe levels' versus 'abstain'). In summary, interventions to reduce unhealthy alcohol use are needed within HIV clinics in Zambia as a substantial population have persistent unhealthy use despite current HIV clinical care. A better understanding is needed regarding the implementation challenges related to screening for unhealthy alcohol use integrated with HIV services.Item Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial.(2023-Apr) Vinikoor MJ; Sharma A; Murray LK; Figge CJ; Bosomprah S; Chitambi C; Paul R; Kanguya T; Sivile S; Nghiem V; Cropsey K; Kane JC; Zambian Ministry of Health, Lusaka, Zambia.; Columbia University Mailman School of Public Health, New York, NY, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; School of Medicine, University Teaching Hospital, University of Zambia, Lusaka, Zambia. Electronic address: michael.vinikoor@cidrz.org.; School of Medicine, University Teaching Hospital, University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Public Health, University of Ghana, Accra, Ghana.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Clinical and quality of life outcomes in people living with human immunodeficiency virus (PLWH) are undermined by unhealthy alcohol use (UAU), which is highly prevalent in this population and is often complicated by mental health (MH) or other substance use (SU) comorbidity. In sub-Saharan Africa, evidence-based and implementable treatment options for people with HIV and UAU are needed. METHODS: We are conducting a hybrid clinical effectiveness-implementation trial at three public-sector HIV clinics in Lusaka, Zambia. Adults with HIV, who report UAU, and have suboptimal HIV clinical outcomes, will be randomized to one of three arms: an alcohol-focused brief intervention (BI), the BI with additional referral to a transdiagnostic cognitive behavioral therapy (Common Elements Treatment Approach [CETA]), or standard of care. The BI and CETA will be provided by HIV peer counselors, a common cadre of lay health worker in Zambia. Clinical outcomes will include HIV viral suppression, alcohol use, assessed by audio computer-assisted self-interview (ACASI) and direct alcohol biomarkers, Phophatidylethanol and Ethyl glucuronide, and comorbid MH and other SU. A range of implementation outcomes including cost effectiveness will also be analyzed. CONCLUSION: Hybrid and 3-arm trial design features facilitate the integrated evaluation of both brief, highly implementable, and more intensive, less implementable, treatment options for UAU among PLWH in sub-Saharan Africa. Use of ACASI and alcohol biomarkers will strengthen understanding of treatment effects.Item Association between hepatitis B co-infection and elevated liver stiffness among HIV-infected adults in Lusaka, Zambia.(2016-Nov) Vinikoor MJ; Mulenga L; Siyunda A; Musukuma K; Chilengi R; Moore CB; Chi BH; Davies MA; Egger M; Wandeler G; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.; Department of Medicine, University of Zambia, Lusaka, Zambia.; School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.; Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Department of Medicine, University of Zambia, Lusaka, Zambia. mjv3@uab.edu.; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. mjv3@uab.edu.; University Teaching Hospital, Lusaka, Zambia.; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. mjv3@uab.edu.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Infectious Diseases, University of Dakar, Dakar, Senegal.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVE: To describe liver disease epidemiology among HIV-infected individuals in Zambia. METHODS: We recruited HIV-infected adults (≥18 years) at antiretroviral therapy initiation at two facilities in Lusaka. Using vibration controlled transient elastography, we assessed liver stiffness, a surrogate for fibrosis/cirrhosis, and analysed liver stiffness measurements (LSM) according to established thresholds (>7.0 kPa for significant fibrosis and >11.0 kPa for cirrhosis). All participants underwent standardised screening for potential causes of liver disease including chronic hepatitis B (HBV) and C virus co-infection, herbal medicine, and alcohol use. We used multivariable logistic regression to identify factors associated with elevated liver stiffness. RESULTS: Among 798 HIV-infected patients, 651 had a valid LSM (median age, 34 years; 53% female). HBV co-infection (12%) and alcohol use disorders (41%) were common and hepatitis C virus co-infection (<1%) was rare. According to LSM, 75 (12%) had significant fibrosis and 13 (2%) had cirrhosis. In multivariable analysis, HBV co-infection as well as male sex, increased age and WHO clinical stage 3 or 4 were independently associated with LSM >7.0 kPa (all P < 0.05). HBV co-infection was the only independent risk factor for LSM >11.0 kPa. Among HIV-HBV patients, those with elevated ALT and HBV viral load were more likely to have significant liver fibrosis than patients with normal markers of HBV activity. CONCLUSIONS: HBV co-infection was the most important risk factor for liver fibrosis and cirrhosis and should be diagnosed early in HIV care to optimise treatment outcomes.Item Awareness and management of elevated blood pressure among human immunodeficiency virus-infected adults receiving antiretroviral therapy in urban Zambia: a call to action.(2017) Bauer S; Wa Mwanza M; Chilengi R; Holmes CB; Zyambo Z; Furrer H; Egger M; Wandeler G; Vinikoor MJ; a Department of Infectious Diseases , Bern University Hospital, University of Bern , Bern , Switzerland.; e Department of Medicine , University of Alabama at Birmingham , Birmingham , USA.; b Centre for Infectious Diseases Research in Zambia , Lusaka , Zambia.; f School of Medicine , University of Zambia , Lusaka , Zambia.; d Institute of Social and Preventive Medicine , University of Bern , Bern , Switzerland.; c School of Medicine , Johns Hopkins University , Baltimore , USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)The prevalence of high blood pressure (HBP) and hypertension (HTN), awareness of the diagnoses, and use of anti-hypertensive drugs were examined among human immunodeficiency virus (HIV)-infected individuals on antiretroviral therapy (ART) in Zambia's capital Lusaka. Within a prospective cohort based at two public sector ART clinics, BP was measured at ART initiation and every 6 months thereafter as a routine clinic procedure. Predictors of HBP (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) during one year on ART were analyzed using logistic regression, and the proportion with HTN (2+ episodes of HBP >3 months apart) described. A phone survey was used to understand patient awareness of HBP, use of anti-hypertensive drugs, and history of cardiovascular events (CVE; myocardial infarction or stroke). Among 896 cohort participants, 887 (99.0%) had at least one BP measurement, 98 (10.9%) had HBP, and 57 (6.4%) had HTN. Increasing age (10-year increase in age: adjusted odds ratio [AOR] = 1.50; 95% confidence interval [CI] 1.20-1.93), male sex (AOR = 2.33, 95% CI 1.43-3.80), and overweight/obesity (AOR = 4.07; 95% CI 1.94-8.53) were associated with HBP. Among 66 patients with HBP, 35 (53.0%) reported awareness of the condition, and nine (25.7%) of these reported having had a CVE. Only 14 (21.2%) of those reached reported ever taking an anti-hypertensive drug, and one (1.5%) was currently on treatment. These data suggest that major improvements are needed in the management of HBP among HIV-infected individuals in settings such as Zambia.Item Care Continuum and Postdischarge Outcomes Among HIV-Infected Adults Admitted to the Hospital in Zambia.(2019-Oct) Haachambwa L; Kandiwo N; Zulu PM; Rutagwera D; Geng E; Holmes CB; Sinkala E; Claassen CW; Mugavero MJ; Wa Mwanza M; Turan JM; Vinikoor MJ; Zambia National Public Health Institute, Lusaka, Zambia.; Center for Global Health and Quality, Georgetown University School of Medicine, Washington, District of Columbia.; Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.; University Teaching Hospital HIV AIDS Programme, Lusaka, Zambia.; Johns Hopkins University, Baltimore, Maryland.; School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.; School of Medicine, University of Zambia, Lusaka, Zambia.; Department of Medicine, University of California at San Francisco, San Francisco, California.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Medicine, University Teaching Hospital, Lusaka, Zambia.; School of Medicine, University of Maryland at Baltimore, Baltimore, Maryland.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: We characterized the extent of antiretroviral therapy (ART) experience and postdischarge mortality among hospitalized HIV-infected adults in Zambia. METHODS: At a central hospital with an opt-out HIV testing program, we enrolled HIV-infected adults (18+ years) admitted to internal medicine using a population-based sampling frame. Critically ill patients were excluded. Participants underwent a questionnaire regarding their HIV care history and CD4 count and viral load (VL) testing. We followed participants to 3 months after discharge. We analyzed prior awareness of HIV-positive status, antiretroviral therapy (ART) use, and VL suppression (VS; <1000 copies/mL). Using Cox proportional hazards regression, we assessed risk factors for mortality. RESULTS: Among 1283 adults, HIV status was available for 1132 (88.2%), and 762 (67.3%) were HIV-positive. In the 239 who enrolled, the median age was 36 years, 59.7% were women, and the median CD4 count was 183 cells/mm CONCLUSIONS: Most HIV-related hospitalizations and deaths may now occur among ART-experienced vs -naïve individuals in Zambia. Development and evaluation of inpatient interventions are needed to mitigate the high risk of death in the postdischarge period.Item Chronic hepatitis B virus coinfection is associated with renal impairment among Zambian HIV-infected adults.(2014-Dec-15) Mweemba A; Zanolini A; Mulenga L; Emge D; Chi BH; Wandeler G; Vinikoor MJ; Department of Medicine, University of Zambia University Teaching Hospital, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill.; Institute of Social and Preventive Medicine, University of Bern Department of Infectious Diseases, University Hospital Bern, Switzerland.; Department of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill Centre for Infectious Disease Research in Zambia, Lusaka.; Department of Medicine, University of Zambia University Teaching Hospital, Lusaka, Zambia Centre for Infectious Disease Research in Zambia, Lusaka.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Among 6789 HIV-infected Zambian adults screened for hepatitis B virus (HBV) coinfection, estimated glomerular filtration rate (eGFR) was 50-90 mL/minute/1.73 m(2) in 17.6% and <50 mL/minute/1.73 m(2) in 2.5%. Human immunodeficiency virus/HBV coinfection was associated with eGFR <50 mL/minute/1.73 m(2) (adjusted odds ratio, 1.96 [95% confidence interval, 1.34-2.86]), adjusted for age, sex, CD4(+) count, and World Health Organization disease stage.Item Chronic hepatitis B virus monoinfection at a university hospital in Zambia.(2018-Sep-27) Vinikoor MJ; Sinkala E; Kanunga A; Muchimba M; Nsokolo B; Chilengi R; Wandeler G; Mulenga J; Chisenga T; Bhattacharya D; Saag MS; Foster G; Fried MW; Kelly P; Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, United States.; Zambian Ministry of Health, Ndeke House, Lusaka 30205, Zambia.; Zambia National Blood Transfusion Service, Private Bag RW1X Ridgeway, Lusaka 50110, Zambia.; Department of Medicine, University of California at Los Angeles, Los Angeles, CA 90035, United States.; Tropical Gastroenterology and Nutrition Group, School of Medicine, University of Zambia, Lusaka 50110, Zambia.; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, United States.; Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern 3012, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka 34681, Zambia.; Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London E1 2AT, United Kingdom.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)AIM: To characterize antiviral therapy eligibility among hepatitis B virus (HBV)-infected adults at a university hospital in Zambia. METHODS: Hepatitis B surface antigen-positive adults ( RESULTS: The median age was 33 years, 71.9% were men, and 30.9% were diagnosed with HBV through a clinically-driven test with the remainder identified CONCLUSION: Approximately one in ten HBV-monoinfected Zambians were eligible for antivirals. Many had indeterminate phenotype and needed clinical follow-up.Item Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.(2020-Dec) Kane JC; Sharma A; Murray LK; Chander G; Kanguya T; Lasater ME; Skavenski S; Paul R; Mayeya J; Kmett Danielson C; Chipungu J; Chitambi C; Vinikoor MJ; University of Zambia, School of Medicine, University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.; Columbia University Mailman School of Public Health, New York, NY, USA.; Zambia Ministry of Health, Lusaka, Zambia.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Medical University of South Carolina, Charleston, SC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)AIMS: Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia. METHODS: The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use. CONCLUSIONS: The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.Item Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial.(2022-May-19) Figge CJ; Kane JC; Skavenski S; Haroz E; Mwenge M; Mulemba S; Aldridge LR; Vinikoor MJ; Sharma A; Inoue S; Paul R; Simenda F; Metz K; Bolton C; Kemp C; Bosomprah S; Sikazwe I; Murray LK; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA, 02115, USA.; Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.; Department of Medicine, University of Alabama at Birmingham, 845 19th Street South, Birmingham, AL, 35294, USA.; Department of Medicine, University of Zambia, PO Box 50110, Lusaka, Zambia.; Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA. cfigge1@jh.edu.; Ministry of Health Zambia, Haille Selassie Avenue, Ndeke House, P.O. Box 30205, Lusaka, Zambia.; Department of Psychiatry, University of Zambia, PO Box 50110, Lusaka, Zambia.; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W 168th St., New York City, NY, 10032, USA.; Department of Global Health, Hans Rosling Center, University of Washington School of Public Health, 3980 15th Ave. NE, Seattle, WA, 98105, USA.; The Centre for Infectious Disease Research (CIDRZ) Zambia, Plot 34620, Lusaka, Zambia.BACKGROUND: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed. METHODS: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context. DISCUSSION: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021.Item Development and validation of a novel scale for antiretroviral therapy readiness among pregnant women in urban Zambia with newly diagnosed HIV infection.(2023-Apr-06) Mubiana-Mbewe M; Bosomprah S; Saroj RK; Kadota J; Koyuncu A; Thankian K; Vinikoor MJ; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Centre for Infectious Diseases Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.; Department of Medicine, University of Alabama at Birmingham, Birmingham, USA.; Centre for Infectious Diseases Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.; UCSF Center for Tuberculosis and Division of Pulmonary and Critical Care Medicine San Francisco General Hospital, University of California, San Francisco, CA, USA.; Department of Gender Studies, University of Zambia, Lusaka, Zambia.; Department of Epidemiology, Johns Hopkins University, Maryland, USA.; School of Computational and Integrative Sciences, Jawaharlal Nehru University, New Delhi, 110067, India.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Women who are newly diagnosed with HIV infection during pregnancy may not be ready to immediately initiate lifelong antiretroviral therapy (ART; called Option B +) as is recommended. Lack of "readiness" drives early disengagement from care and undermines prevention of HIV transmission to infants. Several studies have shown high early attrition of women initiating ART in pregnancy. Although poor ART uptake and adherence have been attributed to various factors including stigma, disclosure issues and structural issues, there is no standard way of determining which pregnant woman will face challenges and therefore need additional support. We developed and validated a novel ART readiness tool in Lusaka, Zambia. METHODS: The aim of this study was to develop and validate a tool that could be used to assess how ready a newly diagnosed pregnant woman living with HIV would be to initiate ART on the day of diagnosis. Using a mixed method design, we conducted this study in three public-setting health facilities in Lusaka, Zambia. Informed by qualitative research and literature review, we identified 27 candidate items. We assessed content validity using expert and target population judgment approaches. We administered the 27-item questionnaire to 454 newly diagnosed pregnant women living with HIV, who were enrolled into a randomized trial (trials number NCT02459678). We performed item reduction analysis and used Cronbach's alpha coefficient of 0.70 as threshold for reliability. RESULTS: A total of 454 pregnant women living with HIV enrolled in the study between March 2017 and December 2017; 452 had complete data for analysis. The correlation coefficient between the 27 items on the completed ART readiness scale ranged from 0.31 to 0.70 while item discrimination index ranged from -0.01 to 2.38. Sixteen items were selected for the final scale, representing three domains, which we classified as "internalized and anticipated HIV stigma", "partner support" and "anticipated structural barriers". CONCLUSION: We developed and validated a tool that could be used to assess readiness of newly diagnosed women living with HIV to initiate ART. This ART readiness tool could allow clinics to tailor limited resources to pregnant women living with HIV needing additional support to initiate and remain on ART.Item Effect of baseline renal function on tenofovir-containing antiretroviral therapy outcomes in Zambia.(2014-May) Mulenga L; Musonda P; Mwango A; Vinikoor MJ; Davies MA; Mweemba A; Calmy A; Stringer JS; Keiser O; Chi BH; Wandeler G; Centre for Infectious Disease Research in Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Although tenofovir disoproxil fumarate (TDF) use has increased as part of first-line antiretroviral therapy (ART) across sub-Saharan Africa, renal outcomes among patients receiving TDF remain poorly understood. We assessed changes in renal function and mortality in patients starting TDF- or non-TDF-containing ART in Lusaka, Zambia. METHODS: We included patients aged ≥16 years who started ART from 2007 onward, with documented baseline weight and serum creatinine. Renal dysfunction was categorized as mild (estimated glomerular filtration rate [eGFR], 60-89 mL/min), moderate (30-59 mL/min), or severe (<30 mL/min) according to the chronic kidney disease-epidemiology (CKD-EPI) formula. Differences in eGFR during ART were analyzed using linear mixed-effect models. The odds of developing moderate or severe eGFR decrease and mortality were assessed using logistic and competing risk regression, respectively. RESULTS: We included 62 230 adults, of which 38 716 (62.2%) initiated a TDF-based regimen. The proportion with moderate or severe renal dysfunction at baseline was lower in the TDF than in the non-TDF group (1.9% vs 4.0%). Among patients with no or mild renal dysfunction, those receiving TDF were more likely to develop moderate (adjusted odds ratio, 3.11; 95% confidence interval, 2.52-3.87) or severe (2.43; 1.80-3.28) eGFR decrease, although the incidence in such episodes was low. Among patients with moderate or severe renal dysfunction at baseline, renal function improved independently of ART regimen, and mortality rates were similar in both treatment groups. CONCLUSIONS: TDF use did not attenuate renal function recovery or increase the mortality rate in patients with renal dysfunction. Further studies are needed to determine the role of routine renal function monitoring before and during ART use in Africa.Item Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial.(2021-Mar) Mubiana-Mbewe M; Bosomprah S; Kadota JL; Koyuncu A; Kusanathan T; Mweebo K; Musokotwane K; Mulenga PL; Chi BH; Vinikoor MJ; Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Department of Medicine, University of Alabama at Birmingham, Birmingham, USA.; Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, USA.; Department of Gender Studies, University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.; Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.; Directorate of Public Health, Zambian Ministry of Health, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)We evaluated the effect of an option B-plus Enhanced Adherence Package (BEAP), on early ART uptake in a randomized controlled trial. HIV-positive, ART naïve pregnant women in Lusaka, Zambia, were randomized to receive BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC). The primary outcome was initiating and remaining on ART at 30 days. Analysis was by intention to treat (ITT) using logistic regression. Additional per protocol analysis was done. We enrolled 454 women; 229 randomized to BEAP and 225 to SOC. Within 30 days of eligibility, 445 (98.2%) initiated ART. In ITT analysis, 82.5% BEAP versus 80.4% SOC participants reached primary outcome (crude relative risk [RR] 1.03; 95% confidence interval [CI] 0.91-1.16; Wald test statistic = 0.44; p-value = 0.66). In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03). Early ART initiation in pregnancy was nearly universal but there was early drop out suggesting need for additional adherence support.This trial was registered at ClinicalTrials.gov (trials number NCT02459678) on May 14, 2015.Item Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial.(2022-Feb) Kane JC; Sharma A; Murray LK; Chander G; Kanguya T; Skavenski S; Chitambi C; Lasater ME; Paul R; Cropsey K; Inoue S; Bosomprah S; Danielson CK; Chipungu J; Simenda F; Vinikoor MJ; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W. 168th Street, Room 519, New York, NY, 10032, USA.; School of Medicine, University of Zambia, University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.; Zambia Ministry of Health, Lusaka, Zambia.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jk4397@cumc.columbia.edu.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W. 168th Street, Room 519, New York, NY, 10032, USA. jk4397@cumc.columbia.edu.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, the Common Elements Treatment Approach (CETA), in reducing unhealthy alcohol use and comorbidities among persons living with HIV (PLWH) in Zambia. Adult PLWH with (a) unhealthy alcohol use plus mental health or substance use comorbidities, or (b) severe unhealthy alcohol use were randomized to receive a single-session alcohol brief intervention (BI) alone or BI plus referral to CETA. Outcomes were measured at baseline and a 6-month follow-up and included Alcohol Use Disorders Identification Test (AUDIT) score (primary), depression and trauma symptoms, and other substance use (secondary). We enrolled 160 participants; 78 were randomized to BI alone and 82 to BI plus CETA. Due to COVID-19, the trial ended early before 36 participants completed. Statistically and clinically significant reductions in mean AUDIT score from baseline to 6-month follow-up were observed in both groups, however, participants assigned to BI plus CETA had significantly greater reductions compared to BI alone (- 3.2, 95% CI - 6.2 to - 0.1; Cohen's d: 0.48). The CETA effect size for AUDIT score increased in line with increasing mental health/substance use comorbidity (0 comorbidities d = 0.25; 1-2 comorbidities d = 0.36; 3+ comorbidities d = 1.6). Significant CETA treatment effects were observed for depression, trauma, and several other substances. BI plus referral to CETA was feasible and superior to BI alone for unhealthy alcohol use among adults with HIV, particularly among those with comorbidities. Findings support future effectiveness testing of CETA for HIV outcomes among PLWH with unhealthy alcohol use.Clinical Trials Number: NCT03966885.Item Elevated AST-to-platelet ratio index is associated with increased all-cause mortality among HIV-infected adults in Zambia.(2015-Jul) Vinikoor MJ; Sinkala E; Mweemba A; Zanolini A; Mulenga L; Sikazwe I; Fried MW; Eron JJ; Wandeler G; Chi BH; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Department of Infectious Diseases, University Hospital Bern, Bern, Switzerland.; Department of Medicine, University of Zambia, Lusaka, Zambia.; Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; University Teaching Hospital, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND & AIMS: We investigated the association between significant liver fibrosis, determined by AST-to-platelet ratio index (APRI), and all-cause mortality among HIV-infected patients prescribed antiretroviral therapy (ART) in Zambia. METHODS: Among HIV-infected adults who initiated ART, we categorized baseline APRI scores according to established thresholds for significant hepatic fibrosis (APRI ≥1.5) and cirrhosis (APRI ≥2.0). Using multivariable logistic regression we identified risk factors for elevated APRI including demographic characteristics, body mass index (BMI), HIV clinical and immunological status, and tuberculosis. In the subset tested for hepatitis B surface antigen (HBsAg), we investigated the association of hepatitis B virus co-infection with APRI score. Using Kaplan-Meier analysis and Cox proportional hazards regression we determined the association of elevated APRI with death during ART. RESULTS: Among 20 308 adults in the analysis cohort, 1027 (5.1%) had significant liver fibrosis at ART initiation including 616 (3.0%) with cirrhosis. Risk factors for significant fibrosis or cirrhosis included male sex, BMI <18, WHO clinical stage 3 or 4, CD4(+) count <200 cells/mm(3) , and tuberculosis. Among the 237 (1.2%) who were tested, HBsAg-positive patients had four times the odds (adjusted odds ratio, 4.15; 95% CI, 1.71-10.04) of significant fibrosis compared HBsAg-negatives. Both significant fibrosis (adjusted hazard ratio 1.41, 95% CI, 1.21-1.64) and cirrhosis (adjusted hazard ratio 1.57, 95% CI, 1.31-1.89) were associated with increased all-cause mortality. CONCLUSION: Liver fibrosis may be a risk factor for mortality during ART among HIV-infected individuals in Africa. APRI is an inexpensive and potentially useful test for liver fibrosis in resource-constrained settings.Item Eligibility for hepatitis B antiviral therapy among adults in the general population in Zambia.(2020) Vinikoor MJ; Sinkala E; Kanunga A; Muchimba M; Zanolini A; Saag M; Pry J; Nsokolo B; Chisenga T; Kelly P; Zambian Ministry of Health, Lusaka, Zambia.; Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.; Department for International Development, Dar Es Salaam, Tanzania.; University of California at Davis, Davis, California, United States of America.; Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.; Tropical Gastroenterology and Nutrition Group, University of Zambia School of Medicine, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Medicine, University Teaching Hospital, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: We evaluated antiviral therapy (AVT) eligibility in a population-based sample of adults with chronic hepatitis B virus (HBV) infection in Zambia. MATERIALS AND METHODS: Using a household survey, adults (18+ years) were tested for hepatitis B surface antigen (HBsAg). Sociodemographic correlates of HBsAg-positivity were identified with multivariable regression. HBsAg-positive individuals were referred to a central hospital for physical examination, elastography, and phlebotomy for HBV DNA, hepatitis B e antigen, serum transaminases, platelet count, and HIV-1/2 antibody. We determined the proportion of HBV monoinfected adults eligible for antiviral therapy (AVT) based on European Association for the Study of the Liver (EASL) 2017 guidelines. We also evaluated the performance of two alternative criteria developed for use in sub-Saharan Africa, the World Health Organization (WHO) and Treat-B guidelines. RESULTS: Across 12 urban and 4 rural communities, 4,961 adults (62.9% female) were tested and 182 (3.7%) were HBsAg-positive, 80% of whom attended hospital follow-up. HBsAg-positivity was higher among men (adjusted odds ratio [AOR], 1.37; 95% confidence interval [CI], 0.99-1.87) and with decreasing income (AOR, 0.89 per household asset; 95% CI, 0.81-0.98). Trends toward higher HBsAg-positivity were also seen at ages 30-39 years (AOR, 2.11; 95% CI, 0.96-4.63) and among pregnant women (AOR, 1.74; 95% CI, 0.93-3.25). Among HBV monoinfected individuals (i.e., HIV-negative) evaluated for AVT, median age was 31 years, 24.6% were HBeAg-positive, and 27.9% had HBV DNA >2,000 IU/ml. AVT-eligibility was 17.0% by EASL, 10.2% by WHO, and 31.1% by Treat-B. Men had increased odds of eligibility. WHO (area under the receiver operating curve [AUROC], 0.68) and Treat-B criteria (AUROC, 0.76) had modest accuracy. Fourteen percent of HBsAg-positive individuals were HIV coinfection, and most coinfected individuals were taking tenofovir-containing antiretroviral therapy (ART). CONCLUSION: Approximately 1 in 6 HBV monoinfected adults in the general population in Zambia may be AVT-eligible. Men should be a major focus of hepatitis B diagnosis and treatment. Further development and evaluation of HBV treatment criteria for resource-limited settings is needed. In settings with overlapping HIV and HBV epidemics, scale-up of ART has contributed towards hepatitis B elimination.Item Evaluation of kidney function among people living with HIV initiating antiretroviral therapy in Zambia.(2022) Pry JM; Vinikoor MJ; Bolton Moore C; Roy M; Mody A; Sikazwe I; Sharma A; Chihota B; Duran-Frigola M; Daultrey H; Mutale J; Kerkhoff AD; Geng EH; Pollock BH; Vera JH; School of Medicine, University of California, Davis, California, United States of America.; School of Medicine University of Alabama, Birmingham, Alabama, United States of America.; Ersilia Open Source Initiative, Cambridge, United Kingdom.; School of Medicine, Washington University, St. Louis, Missouri, United States of America.; School of Medicine, University of California, San Francisco, California, United States of America.; Centre for Infectious Disease Research Zambia (CIDRZ), Lusaka, Zambia.; Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom.As the response to the HIV epidemic in sub-Saharan Africa continues to mature, a growing number of people living with HIV (PLHIV) are aging and risk for non-communicable diseases increases. Routine laboratory tests of serum creatinine have been conducted to assess HIV treatment (ART) suitability. Here we utilize those measures to assess kidney function impairment among those initiating ART. Identification of non-communicable disease (NCD) risks among those in HIV care creates opportunity to improve public health through care referral and/or NCD/HIV care integration. We estimated glomerular filtration rates (eGFR) using routinely collected serum creatinine measures among a cohort of PLHIV with an HIV care visit at one of 113 Centre for Infectious Disease Research Zambia (CIDRZ) supported sites between January 1, 2011 and December 31, 2017, across seven of the ten provinces in Zambia. We used mixed-effect Poisson regression to assess predictors of eGFR <60ml/min/1.73m2 allowing random effects at the individual and facility level. Additionally, we assessed agreement between four eGFR formulae with unadjusted CKD-EPI as a standard using Scott/Fleiss method across five categories of kidney function. A total of 72,933 observations among 68,534 individuals met the inclusion criteria for analysis. Of the 68,534, the majority were female 41,042 (59.8%), the median age was 34 (interquartile range [IQR]: 28-40), and median CD4 cell count was 292 (IQR: 162-435). The proportion of individuals with an eGFR <60ml/min/1.73m2 was 6.9% (95% CI: 6.7-7.1%) according to the unadjusted CKD-EPI equation. There was variation in agreement across eGFR formulas considered compared to unadjusted CKD-EPI (χ2 p-value <0.001). Estimated GFR less than 60ml/min/1.73m2, per the unadjusted CKD-EPI equation, was significantly associated with age, sex, body mass index, and blood pressure. Using routine serum creatinine measures, we identified a significant proportion of individuals with eGFR indicating moderate or great kidney function impairment among PLHIV initiating ART in Zambia. It is possible that differentiated service delivery models could be developed to address this subset of those in HIV care with increased risk of chronic kidney disease.
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