Browsing by Author "Vinikoor, Michael J."

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A new approach to prevent, diagnose, and treat hepatitis B in Africa.
(2023) Spearman, Wendy C.; Andersson, Monique I.; Bright, Bisi; Davwar, Pantong M.; Desalegn, Hailemichael ; Guingane, Alice N.; Johannessen, Asgeir; Kabagambe, Kenneth; Lemoine, Maud; Matthews, Philippa C.; Ndow, Gibril; Riches, Nicholas; Shimakawa, Yusuke; Sombié, Roger; Stockdale, Alexander J.; Taljaard, Jantjie J.; Vinikoor, Michael J.; Wandeler, Gilles ; Okeke, Edith; Sonderup, Mark
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.
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, Mwangelwa; Bosomprah, Samuel; Saroj, Rakesh K.; Kadota, Jillian; Koyuncu, Aybuke; Thankian, Kusanthan; Vinikoor, Michael J.
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.
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, Jeremy C.; Sharma, Anjali; Murray, Laura K.; Chander, Geetanjali; Kanguya, Tukiya; Skavenski, Stephanie; Chitambi, Chipo; Lasater, Molly E.; Paul, Ravi; Cropsey, Karen; Inoue, Sachi; Bosomprah, Samuel; Danielson, Carla K.; Chipungu, Jenala; Simenda, Francis; Vinikoor, Michael J.
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.
Growth patterns of infants with in- utero HIV and ARV exposure in Cape Town, South Africa and Lusaka, Zambia.
(2022-Jan-10) Nyemba, Dorothy C.; Kalk, Emma; Vinikoor, Michael J.; Madlala, Hlengiwe P.; Mubiana-Mbewe, Mwangelwa ; Mzumara, Maureen; Bolton-Moore, Carolyn ; Slogrove, Amy L.; Boulle, Andrew; Davies, Mary-Ann; Myer, Landon; Powis, Kathleen
BACKGROUND: Infants born HIV-exposed yet remain uninfected (HEU) are at increased risk of poorer growth and health compared to infants born HIV-unexposed (HU). Whether maternal antiretroviral treatment (ART) in pregnancy ameliorates this risk of poorer growth is not well understood. Furthermore, whether risks are similar across high burden HIV settings has not been extensively explored. METHODS: We harmonized data from two prospective observational studies conducted in Cape Town, South Africa, and Lusaka, Zambia, to compare weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ) Z-scores between infants who were HEU and HU, converting infant anthropometric measures using World Health Organisation Growth Standards adjusted for age and sex. Linear mixed effects models were fit to identify risk factors for differences in anthropometrics at 6-10 weeks and 6 months by infant HIV exposures status and by timing of exposure to maternal ART, either from conception or later in gestation. RESULTS: Overall 773 mother-infant pairs were included across two countries: women living with HIV (WLHIV), 51% (n = 395) with 65% on ART at conception and 35% initiating treatment in pregnancy. In linear mixed effects models, WAZ and WLZ at 6-10 weeks were lower among infants who were HEU vs HU [β = - 0.29 (95% CI: - 0.46, - 0.12) and [β = - 0.42 (95% CI: - 0.68, - 0.16)] respectively after adjusting for maternal characteristics and infant feeding with a random intercept for country. At 6 months, LAZ was lower [β = - 0.28 CI: - 0.50, - 0.06)] among infants who were HEU, adjusting for the same variables, with no differences in WAZ and WLZ. Within cohort evaluations identified different results with higher LAZ among infants who were HEU from Zambia at 6-10 weeks, [β = + 0.34 CI: + 0.01, + 0.68)] and lower LAZ among infants who were HEU from South Africa [β = - 0.30 CI: - 0.59, - 0.01)] at 6 months, without other anthropometric differences at either site. CONCLUSION: Infant growth trajectories differed by country, highlighting the importance of studying contextual influences on outcomes of infants who were HEU.
Liver steatosis and metabolic dysfunction-associated fatty liver disease among HIV-positive and negative adults in urban Zambia.
(2022-Jul) Chihota, Belinda V.; Riebensahm, Carlotta; Muula, Guy; Sinkala, Edford; Chilengi, Roma; Mulenga, Lloyd; Bosomprah, Samuel; Vinikoor, Michael J.; Bolton-Moore, Carolyn; Egger, Matthias; Rauch, Andri; Berzigotti, Annalisa; Wandeler, Gilles
INTRODUCTION: The growing importance of non-communicable diseases (NCDs) and high HIV prevalence in urban African settings may increase the burden of metabolic dysfunction-associated fatty liver disease (MAFLD). We assessed liver steatosis among HIV-positive and negative adults in urban Zambia. METHODS: Adults 30 years and older who were newly diagnosed with HIV, or tested HIV-negative at two primary care clinics in Lusaka, Zambia, were assessed for liver steatosis. Cardiometabolic data were collected through comprehensive clinical and laboratory assessments. Transient elastography was performed to measure controlled-attenuation parameter (≥248 dB/m). We used multivariable logistic regression models to determine the factors associated with the presence of steatosis. RESULTS: We enrolled 381 patients, including 154 (40%) antiretroviral therapy-naïve people living with HIV (PLWH) with a median CD4+ count of 247 cells/mm CONCLUSIONS: The prevalence of liver steatosis in this urban cohort of HIV-positive and negative adults in Zambia was low, despite a large proportion of patients with high BMI and central obesity. Our study is among the first to report data on MAFLD among adults in Africa, demonstrating that metabolic risk factors are key drivers of liver steatosis and supporting the adoption of the criteria for MAFLD in African populations.
Trends in hepatitis B virus testing practices and management in HIV clinics across sub-Saharan Africa.
(2017-Nov-01) Coffie, Patrick A.; Egger, Matthias; Vinikoor, Michael J.; Zannou, Marcel; Diero, Lameck; Patassi, Akouda; Kuniholm, Mark H.; Seydi, Moussa; Bado, Guillaume; Ocama, Ponsiano; Andersson, Monique I.; Messou, Eugène; Minga, Albert; Easterbrook, Philippa; Anastos, Kathryn; Dabis, François; Wandeler, Gilles
BACKGROUND: Approximately 8% of HIV-infected individuals are co-infected with hepatitis B virus (HBV) in sub-Saharan Africa (SSA). Knowledge of HBV status is important to guide optimal selection of antiretroviral therapy (ART) and monitor/prevent liver-related complications. We describe changes in testing practices and management of HBV infection over a 3-year period in HIV clinics across SSA. METHODS: A medical chart review was conducted in large urban HIV treatment centers in Côte d'Ivoire (3 sites), Benin, Burkina Faso, Cameroon, Kenya, Senegal, South Africa, Togo, Uganda and Zambia (1 site each). Of the patients who started ART between 2010 and 2012, 100 per year were randomly selected from each clinic. Demographic, clinical and laboratory information as well as individual treatment histories were collected using a standardized questionnaire. We examined changes over time in the proportion of patients screened for HBV infection (HBV surface antigen [HBsAg]-positivity), identified predictors of HBV testing using logistic regression, and assessed the proportion of patients initiating a tenofovir (TDF)-containing ART regimen. RESULTS: Overall, 3579 charts of patients initiating ART (64.4% female, median age 37 years) were reviewed in 12 clinics. The proportion of patients screened for HBsAg increased from 17.8% in 2010 to 24.4% in 2012 overall, and ranged from 0.7% in Kenya to 96% in South Africa. In multivariable analyses, age and region were associated with HBsAg screening. Among 759 individuals tested, 88 (11.6%; 95% confidence interval [CI] 9.4-14.1) were HBV-infected, of whom 71 (80.7%) received a TDF-containing ART regimen. HBsAg-positive individuals were twice as likely to receive a TDF-containing first-line ART regimen compared to HBsAg-negative patients (80.7% vs. 40.3%, p < 0.001). The proportion of patients on TDF-containing ART increased from 57.9% in 2010 to 90.2% in 2012 in HIV/HBV-co-infected patients (Chi-2 test for trend: p = 0.01). Only 114 (5.0%) patients were screened for anti-HCV antibodies and one of them (0.9%, 95% CI 0.02-4.79) had a confirmed HCV infection. CONCLUSIONS: The systematic screening for HBV infection in HIV-positive patients before ART initiation was limited in most African countries and its uptake varied widely across clinics. Overall, the prescription of TDF increased over time, with 90% of HIV/HBV-coinfected patients receiving this drug in 2012.
Validation of a Point-Of-Care Ultrasound for Hepatitis Among Front-Line Healthcare Workers Managing Chronic Hepatitis B Virus Infection in Zambia.
(2026-Sep) Bertoni, Costanza; Kanunga, Annie; Sinkala, Edford ; Syabbalo, Enock; Chitundu, Helen; Chikwezi, Alick ; Chibundi, Carolyn; Muula, Guy K.; Bosomprah, Samuel; Capra, Nicolò ; Lolatto, Riccardo; Morsica, Giulia; Castagna, Antonella; Wallrauch, Claudia; Heller, Tom; Vinikoor, Michael J.
To close gaps in implementing care of people with hepatitis B virus (HBV) infection in resource-limited settings, we evaluated the accuracy of a novel liver point-of-care ultrasound (POCUS) protocol for hepatitis (PUSH) among front-line non-radiology healthcare workers in Zambia. At University Teaching Hospital in Lusaka, Zambia, from March to June 2024, we trained four nurses and six physicians with experience in HBV management, but not in ultrasound (US), in the PUSH protocol, which includes visualizing the liver in three windows (epigastric, subcostal and right transcostal) to identify cirrhosis-suggestive features and liver lesions suspicious for hepatocellular carcinoma (HCC). Then, consecutive adult participants with chronic hepatitis B (PWHB) alone or HBV/HIV coinfection underwent PUSH with operators blinded to clinical data. We evaluated the accuracy of PUSH for significant fibrosis and cirrhosis using transient elastography (TE) as the reference standard test (RST) and for liver lesions that were possible HCC using a comprehensive abdominal ultrasound by an experienced radiographer as the RST. Nonparametric analysis of the receiver operating curve (ROC) for PUSH was adjusted for operator type (doctor vs. nurse), sex and HIV status. Among 197 PWHBs analysed, 69.5% were taking HBV antivirals and 27.9% had HBV/HIV. According to RSTs, 17.7% of PWHBs had significant fibrosis, 11.6% had cirrhosis and 3.5% had liver lesions. PUSH had low accuracy for significant fibrosis, with sensitivity of 8.3% (17.5-41.4), specificity of 100.0% (96.1-100) and an area under the curve (AUROC) of 0.54 (0.43-0.65), moderate accuracy for cirrhosis, with sensitivity of 60.9% (38.5-80.3), specificity of 97.7% (94.2-99.4) and AUROC of 0.79 (0.69-0.89), and higher accuracy for liver lesions, with 85.7% (42.1-99.6) sensitivity, 98.4% (95.5-99.7) specificity, AUROC of 0.92 (0.78-1.00). After an expedited training, front-line nurses and physicians treating HBV in Zambia were able to use PUSH to diagnose cirrhosis with moderate accuracy and liver lesions with high accuracy, although confidence intervals around performance estimates were wide. Liver POCUS including PUSH may be useful in HBV management when laboratory systems and TE are lacking.