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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.

Through a nationally-representative household survey, we measured the prevalence and correlates of unhealthy alcohol use (UAU) in Zambia and its association with the HIV care continuum. Adolescent and adult (ages 15-59 years) data, including the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), from the 2016 Zambia Population-based HIV Impact Assessment, were analyzed. UAU was defined as AUDIT-C of 3 + points for women and 4 + for men. Among 20,923 participants, 15.3% had UAU; this was 21.6% among people living with HIV (PLWH). Male sex, increasing age, being employed, urban residence, and having HIV were independent correlates of UAU (all

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 naive 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.

Hepatosplenic schistosomiasis (HSS) complicates portal hypertension, leading to life-threatening variceal bleeding. Variceal bleeding is associated with increased portal vein diameter (PVD). Beta-blockers prevent variceal bleeding. It is unclear whether beta-blockers such as propranolol can reduce PVD in HSS. We aimed to explore the effect of propranolol on PVD in HSS. A longitudinal study was conducted at the University Teaching Hospital, Zambia, as an extension of a clinical trial of rifaximin undertaken to test the hypothesis that rifaximin could reduce bacterial translocation in HSS. We randomized 85 adults to either rifaximin and standard care, or propranolol-based standard care only for 42 days. We then followed up all the patients on propranolol up to day 180. We used ultrasound to measure PVD at baseline and day 180. The primary outcome was reduction in PVD. Beta-blockade and splenic size reduction were secondary outcomes. Portal vein diameter reduced after 180 days of propranolol therapy from median 12 mm (interquartile range (IQR): 11–14) to median 10 mm (IQR: 9–13) (P < 0.001). The pulse rate reduced from baseline median 70 beats/minute (IQR: 66–80) to 65 beats/minute (IQR: 60–70) by day 180 (P = 0.006). Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6–11) to 12 g/dL (10–14) (P < 0.001). Splenic size remained unchanged. Propranolol led to the reduction in PVD over 180 days. This suggests that ultrasound could be useful in monitoring response and compliance to beta-blockers, especially in resource-constraint areas where portal hypertension measurement facilities are unavailable.

Background Though antiretroviral therapy (ART) is widely available, HIV positive pregnant women in Zambia are less likely to start and remain on therapy throughout pregnancy and after delivery. This study sought to understand readiness to start ART among HIV pregnant women from the perspectives of both women and men in order to suggest more holistic programs to support women to continue life-long ART after delivery. Methods We conducted a qualitative study with HIV positive pregnant women before and after ART initiation, and men with female partners, to understand readiness to start lifelong ART. We conducted 28 in-depth interviews among women and 2 focus group discussions among male partners. Data were transcribed verbatim and analyzed in NVivo 12 using thematic analysis. Emerging themes from the data were organized using the social ecological framework. Results Men thought of their female partners as young and needing their supervision to initiate and stay on ART. Women agreed that disclosure and partner support were necessary preconditions to ART initiation and adherence and, expressed fear of divorce as a prominent barrier to disclosure. Maternal love and desire to look after one’s children instilled a sense of responsibility among women which motivated them to overcome individual, interpersonal and health system level barriers to initiation and adherence. Women preferred adherence strategies that were discrete, the effectiveness of which, depended on women’s intrinsic motivation. Conclusion The results support current policies in Zambia to encourage male engagement in ART care. To appeal to male partners, messaging on ART should be centered on emphasizing the importance of male involvement to ensure women remain engaged in ART care. Programs aimed at supporting postpartum ART adherence should design messages that appeal to both men’s role in couples’ joint decision-making and women’s maternal love as motivators for adherence.

Background Zambia recently achieved UNAIDS 90-90-90 treatment targets for HIV epidemic control; however, inpatient facilities continue to face a large burden of patients with advanced HIV disease and HIV-related mortality. Management of advanced HIV disease, following guidelines from outpatient settings, may be more difficult within complex inpatient settings. We evaluated adherence to HIV guidelines during hospitalization, including opportunistic infection (OI) screening, treatment, and prophylaxis. Methods We reviewed inpatient medical records of people living with HIV (PLHIV) admitted to the University Teaching Hospital in Lusaka, Zambia between December 1, 2018 and April 30, 2019. We collected data on patient demographics, antiretroviral therapy (ART), HIV biomarkers, and OI screening and treatment—including tuberculosis (TB), Cryptococcus, and OI prophylaxis with co-trimoxazole (CTX). Screening and treatment cascades were constructed based on the 2017 WHO Advanced HIV Guidelines. Results We reviewed files from 200 charts of patients with advanced HIV disease; of these 92% (184/200) had been on ART previously; 58.1% (107/184) for more than 12 months. HIV viral load (VL) testing was uncommon but half of VL results were high. 39% (77/200) of patients had a documented CD4 count result. Of the 172 patients not on anti-TB treatment (ATT) on admission, TB diagnostic tests (either sputum Xpert MTB/RIF MTB/RIF or urine TB-LAM) were requested for 105 (61%) and resulted for 60 of the 105 (57%). Nine of the 14 patients (64%) with a positive lab result for TB died before results were available. Testing for Cryptococcosis was performed predominantly in patients with symptoms of meningitis. Urine TB-LAM testing was rarely performed. Conclusions At a referral hospital in Zambia, CD4 testing was inconsistent due to laboratory challenges and this reduced recognition of AHD and implementation of AHD guidelines. HIV programs can potentially reduce mortality and identify PLHIV with retention and adherence issues through strengthening inpatient activities, including reflex VL testing, TB-LAM and serum CrAg during hospitalization.

Background This study evaluated the test characteristics of brief versions of the Alcohol Use Disorders Identification Test (AUDIT), the AUDIT-C and AUDIT-3, compared to the full AUDIT in populations with heavy drinking living in Zambia and compared differences in effect size estimates when using brief versions in clinical trials. Methods Data were obtained from two randomized trials of the Common Elements Treatment Approach (CETA) for reducing unhealthy alcohol use among adult couples and people living with HIV (PLWH) in Zambia. The full AUDIT was administered to participants at baseline and at 6- or 12-month follow-up. Sensitivity and specificity of the brief versions were calculated in comparison to the full AUDIT. Mixed effects regression models were estimated to calculate the effect sizes from the trials using the brief versions and these were compared to the originally calculated effect sizes using the full version. Results The AUDIT-C performed well at cut-off ≥ 3 for both men (sensitivity: >80%; specificity: >76%) and women (sensitivity: >84%; specificity: >88%). The AUDIT-3 performed best at cut-off ≥ 1, but with comparatively reduced validity for men (sensitivity: >77%; specificity: ≥60%) and women (sensitivity: ≥72%; specificity: >62%). Effect sizes were different by up to 52% using the AUDIT-C and up to 60% for the AUDIT-3 compared to the AUDIT. Conclusions The AUDIT-C is recommended as a brief screening tool for community-based and clinic-based screening in Zambia among populations with high prevalence of unhealthy alcohol use. For research studies, the full AUDIT is recommended to calculate treatment effect.

BACKGROUND Hazardous alcohol use is a predictor of intimate partner violence (IPV), and both are increasingly prevalent in sub-Saharan Africa. The accurate measurement of alcohol consumption is therefore critical in IPV intervention studies that target hazardous drinking. Collecting a collateral report in addition to self-report is one convergent validity approach to improve alcohol measurement. We investigated concordance between self- and partner-reported alcohol use among women who reported recent IPV and their male partners in Zambia. METHODS Data were from the baseline of a randomized IPV intervention trial of 247 heterosexual couples in which a woman has reported recent IPV and her male partner has recent hazardous alcohol use. Both partners completed the Alcohol Use Disorders Identification Test (AUDIT) in reference to their own drinking and in reference to their partner's drinking. We calculated percent agreement across a range of outcomes: any use, quantity, frequency, and hazardous use. We also compared self- and partner-reported AUDIT scores using t-tests. RESULTS Concordance was poor across most outcomes. Percent agreement with respect to the women's drinking ranged from 60% to 65% across outcomes and with respect to the men's drinking from 51% to 89%. Women's average partner-reported AUDIT score (20.7) was statistically significantly (p

Among 284 human immunodeficiency virus (HIV)-hepatitis B virus (HBV) coinfected adults starting tenofovir-based antiretroviral therapy (ART) in Zambia, median baseline CD4+ count was 202 cells/mm3 and 41.6% were hepatitis B e-antigen positive. Within 2 years of therapy, 29 (10.2%) participants experienced HBV functional cure (confirmed loss of hepatitis B surface antigen). In multivariable analysis, baseline CD4 count

Background Human immunodeficiency virus type 1 (HIV-1) populations are detected in cerebrospinal fluid (CSF) of some people on suppressive antiretroviral therapy (ART). Detailed analysis of these populations may reveal whether they are produced by central nervous system (CNS) reservoirs. Methods We performed a study of 101 asymptomatic participants on stable ART. HIV-1 RNA concentrations were cross-sectionally measured in CSF and plasma. In participants with CSF HIV-1 RNA concentrations sufficient for analysis, viral populations were genetically and phenotypically characterized over multiple time points. Results For 6% of participants (6 of 101), the concentration of HIV-1 RNA in their CSF was ≥0.5 log copies/mL above that of plasma (ie, CSF escape). We generated viral envelope sequences from CSF of 3 participants. One had a persistent CSF escape population that was macrophage-tropic, partially drug resistant, genetically diverse, and closely related to a minor macrophage-tropic lineage present in the blood prior to viral suppression and enriched for after ART. Two participants (1 suppressed and 1 not) had transient CSF escape populations that were R5 T cell-tropic with little genetic diversity. Conclusions Extensive analysis of viral populations in 1 participant revealed that CSF escape was from a persistently replicating population, likely in macrophages/microglia, present in the CNS over 3 years of ART. CSF escape in 2 other participants was likely produced by trafficking and transient expansion of infected T cells in the CNS. Our results show that CNS reservoirs can persist during ART and that CSF escape is not exclusively produced by replicating CNS reservoirs.

BackgroundThough antiretroviral therapy (ART) is widely available, HIV positive pregnant women in Zambia are less likely to start and remain on therapy throughout pregnancy and after delivery. This study sought to understand readiness to start ART among HIV pregnant women from the perspectives of both women and men in order to suggest more holistic programs to support women to continue life-long ART after delivery.MethodsWe conducted a qualitative study with HIV positive pregnant women before and after ART initiation, and men with female partners, to understand readiness to start lifelong ART. We conducted a total of 28 in-depth interviews among women and 2 focus group discussions among male partners. Data was transcribed verbatim and analyzed in NVivo 12 using thematic analysis. Emerging themes from the data were organized using the social ecological framework.ResultsMen thought of their female partners as young and needing their supervision to initiate and stay on ART. Women agreed that disclosure and partner support were necessary preconditions to ART initiation and adherence and expressed fear of divorce as a prominent barrier to disclosure. Maternal love and desire to look after one’s children instilled a sense of responsibility among women which motivated them to overcome individual, interpersonal and health system level barriers to initiation and adherence. Women preferred adherence strategies that were discrete, the effectiveness of which, depended on women’s intrinsic motivation.ConclusionThe results support current policies in Zambia to encourage male engagement in ART care. To appeal to male partners, messaging on ART should be centered on emphasizing the importance of male involvement to ensure women remain engaged in ART care. Programs aimed at supporting postpartum ART adherence should design messages that appeal to both men’s role in couples’ joint decision-making and women’s maternal love as motivators for adherence.

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.

Summary Background The proportion of children living with HIV and receiving antiretroviral therapy (ART) in sub-Saharan Africa has increased greatly since 2006, yet the changes in their demographic characteristics and treatment outcomes have not been well described. We examine the trends in characteristics and outcomes of children living with HIV who were younger than 5 years at ART initiation, and compare outcomes over time and across country income groups. Methods We conducted a retrospective cohort analysis of data from children living with HIV who were younger than 5 years at ART initiation from 45 paediatric sites in 16 low-income, lower-middle-income, and upper-middle-income countries in sub-Saharan Africa (Benin, Burundi, Cote d'Ivoire, Democratic Republic of the Congo, Ghana, Kenya, Lesotho, Malawi, Mali, Mozambique, Rwanda, South Africa, Togo, Uganda, Zambia, and Zimbabwe). Outcomes were trends in patient characteristics at ART initiation (age, weight, height, and CD4%), and comparisons of mortality and loss to follow-up during ART over time and in various economic settings. We identified risk factors for mortality using Cox proportional hazards models. Each participating region had relevant institutional ethics review board approvals to contribute data to the analysis. Findings We included 32 221 children living with HIV and initiating ART younger than 5 years between Jan 1, 2006, and Dec 31, 2017. Median age at ART initiation was 20·4 months (IQR 9·4–36·0) in 2006–10, 19·2 months (8·3–33·6) in 2011–13, and 19·2 months (8·8–33·7) in 2014–17. Median age at ART initiation was 13·2 months (IQR 4·7–26·8) in upper-middle-income countries, 22·6 months (13·2–37·5) in lower-middle-income countries and 24·2 months (13·5–39·1) in low-income countries. The proportion of children initiating ART younger than 3 months increased from 770 (5·1%) of 14 943 children in 2006–10 to 728 (10·0%) of 7290 children in 2014–17. The proportion of children initiating ART with severe immunosuppression decreased from 5469 (74·7%) of 7314 children for whom CD4% data were available in 2006–10 to 2353 (55·2%) of 4269 children in 2014–17. Mortality at 24 months on ART decreased from 970 (6·5%) of 14 943 children in 2006–10 to 214 (2·9%) of 7290 children in 2014–17. Loss to follow-up was 20·5% (95% CI 20·1–21·0) overall, and was similar across time periods. In multivariable analysis, lower mortality was observed for more recent ART initiation cohorts (adjusted hazard ratio 0·70, 95% CI 0·63–0·79 for 2011–13; 0·53, 0·45–0·72 for 2014–17 vs 2006–10) and for those residing in an upper-middle-income country (0·42, 0·35–0·49 vs low-income countries). Interpretation Mortality declined significantly after universal ART recommendations for children younger than 2 years in 2010 and children younger than 5 years in 2013. However, substantial variations persisted across country income groups, and one in five children continue to be lost to follow-up. Targeted interventions are required to improve outcomes of children living with HIV, especially in the poorest countries. Funding National Institute of Allergy and Infectious Disease.

Highlights • Unhealthy alcohol use is common among persons living with HIV (PLWH). • In sub-Saharan Africa, there are limited treatment options for unhealthy alcohol use. • This RCT tests multiple interventions at reducing unhealthy alcohol use in SSA., 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.

BACKGROUND After first-line antiretroviral therapy failure, the importance of change in nucleoside reverse transcriptase inhibitor (NRTI) in second line is uncertain due to the high potency of protease inhibitors used in second line. SETTING We used clinical data from 6290 adult patients in South Africa and Zambia from the International Epidemiologic Databases to Evaluate AIDS (IeDEA) Southern Africa cohort. METHODS We included patients who initiated on standard first-line antiretroviral therapy and had evidence of first-line failure. We used propensity score-adjusted Cox proportional-hazards models to evaluate the impact of change in NRTI on second-line failure compared with remaining on the same NRTI in second line. In South Africa, where viral load monitoring was available, treatment failure was defined as 2 consecutive viral loads >1000 copies/mL. In Zambia, it was defined as 2 consecutive CD4 counts

Cirrhosis is the dominant cause of portal hypertension globally but may be overshadowed by hepatosplenic schistosomiasis (HSS) in the tropics. In Zambia, schistosomiasis seroprevalence can reach 88% in endemic areas. Bacterial translocation (BT) drives portal hypertension in cirrhosis contributing to mortality but remains unexplored in HSS. Rifaximin, a non-absorbable antibiotic may reduce BT. We aimed to explore the influence of rifaximin on BT, inflammation, and fibrosis in HSS. In this phase II open-label trial (ISRCTN67590499), 186 patients with HSS in Zambia were evaluated and 85 were randomized to standard care with or without rifaximin for 42 days. Changes in markers of inflammation, BT, and fibrosis were the primary outcomes. BT was measured using plasma 16S rRNA, lipopolysaccharide-binding protein, and lipopolysaccharide, whereas hyaluronan was used to measure fibrosis. Tumor necrosis factor receptor 1 (TNFR1) and soluble cluster of differentiation 14 (sCD14) assessed inflammation. 16S rRNA reduced from baseline (median 146 copies/µL, interquartile range [IQR] 9, 537) to day 42 in the rifaximin group (median 63 copies/µL, IQR 12, 196), P < 0.01. The rise in sCD14 was lower (P < 0.01) in the rifaximin group (median rise 122 ng/mL, IQR-184, 783) than in the non-rifaximin group (median rise 832 ng/mL, IQR 530, 967). TNFR1 decreased (P < 0.01) in the rifaximin group (median -39 ng/mL IQR-306, 563) but increased in the non-rifaximin group (median 166 ng/mL, IQR 3, 337). Other markers remained unaffected. Rifaximin led to a reduction of inflammatory markers and bacterial 16S rRNA which may implicate BT in the inflammation in HSS.

Background Hepatocellular malignancy in young adults is a prominent feature of hepatitis B virus (HBV) infection in southern Africa. Here we report a cross-sectional study of liver pathology correlated with biomarkers in adults with HBV infection in Zambia. Methods We analysed liver biopsies from Zambian patients with persistent HBV infection. Results We analysed 104 patients with HBV infection and evidence of liver disease. We obtained liver biopsies from 53 adults; of these, 12 (23%) were hepatitis B e antigen seropositive. The genotype was evenly distributed between A and E. One biopsy showed malignancy. Stage was 3 or more in 11 of 52 (21%) biopsies free of malignancy and lobular inflammation was found in 50 (94%). Neither alanine aminotransferase (ALT) nor the γ-glutamyl transferase:platelet ratio (GPR) were correlated with the stage of disease but were correlated with total Ishak score (ρ=0.47, p=0.0004 and ρ=0.33, p=0.02, respectively). Large cell change was observed in 10 of 11 biopsies with fibrosis stage 3 or more and 16 of 41 with early disease (p=0.005). Serum α-fetoprotein was elevated, although still within the normal range, in patients with large cell change (median 3.6 [interquartile range {IQR} 1.6–5.1]) compared with those without (1.7 [IQR 1.0–2.8]; p=0.03). Neither ALT nor GPR predicted large cell change. Conclusions Large cell change was common in young HBV-infected adults in Zambia. Only serum α-fetoprotein was identified as a biomarker of this phenotype.

In East and Southern Africa, where 5-10% have chronic hepatitis B virus (HBV) infection, incidence of human immunodeficiency virus (HIV) infection remains unacceptably high. This introduces challenges and opportunities for implementation of HBV care and treatment. We now describe new HIV diagnoses made within an HBV monoinfection cohort in Zambia and their relevance to broader HBV policy implementation. This article is protected by copyright. All rights reserved.

Background: We investigated changes in hepatic fibrosis, based on transient elastography (TE), among human immunodeficiency virus (HIV)-infected patients with and without hepatitis B virus (HBV) coinfection on antiretroviral therapy (ART) in Zambia. Methods: Patients' liver stiffness measurements (LSM; kiloPascals [kPa]) at ART initiation were categorized as no or minimal fibrosis (equivalent to Metavir F0-F1), significant fibrosis (F2-F3), and cirrhosis (F4). TE was repeated following 1 year of ART. Stratified by HBV coinfection status (hepatitis B surface antigen positive at baseline), we described LSM change and the proportion with an increase/decrease in fibrosis category. Using multivariable logistic regression, we assessed correlates of significant fibrosis/cirrhosis at 1 year on ART. Results: Among 463 patients analyzed (61 with HBV coinfection), median age was 35 years, 53.7% were women, and median baseline CD4+ count was 240 cells/mm3. Nearly all (97.6%) patients received tenofovir disoproxil fumarate-containing ART, in line with nationally recommended first-line treatment. The median LSM change was -0.70 kPa (95% confidence interval, -3.0 to +1.7) and was similar with and without HBV coinfection. Significant fibrosis/cirrhosis decreased in frequency from 14.0% to 6.7% (P < .001). Increased age, male sex, and HBV coinfection predicted significant fibrosis/cirrhosis at 1 year (all P < .05). Conclusion: The percentage of HIV-infected Zambian adults with elevated liver stiffness suggestive of significant fibrosis/cirrhosis decreased following ART initiation-regardless of HBV status. This suggests that HIV infection plays a role in liver inflammation. HBV-coinfected patients were more likely to have significant fibrosis/cirrhosis at 1 year on ART. Clinical Trials Registration: NCT02060162.

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; 6 months on ART, 74.4% had VS. The majority (92.5%) were discharged, and by 3 months, 48 (21.7%) had died. Risk of postdischarge mortality increased with decreasing CD4, and there was a trend toward reduced risk in those treated for active tuberculosis. 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., In Zambia, 86% of hospitalized HIV-infected adults were antiretroviral therapy–experienced, 50% were virally suppressed, and 71% had advanced HIV disease. Mortality within 3 months of discharge was 20%. Advanced HIV disease interventions should target inpatients in sub-Saharan Africa.

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., Olga Tymejczyk and colleagues report on the impact of WHO's universal treatment recommendation for people with HIV in sub-Saharan African countries., Author summary Why was this study done? Since late 2015, the World Health Organization (WHO) has recommended that all people living with HIV (PLWH) initiate ART, regardless of disease stage and CD4 cell count, and as of mid-2018, 84% of low- and middle-income countries had formally adopted WHO’s recommendation to provide universal treatment to all PLWH. While modeling studies and trials have indicated that universal treatment, or “treat all,” increases rapid ART initiation and viral load suppression among patients, there is little evidence on the impact of treat all policies on uptake of ART in real-world implementation settings. What did the researchers do and find? We assessed rapid ART initiation (i.e., ART initiation within 30 days of enrolling into HIV care) among 814,603 patients before and after national adoption of treat all policies in 6 countries in sub-Saharan Africa (Burundi, Kenya, Malawi, Rwanda, Uganda, and Zambia). To compare rapid ART initiation among those enrolling into care just before and just after national adoption of the treat all policy, we used a regression discontinuity design, using the date of HIV care enrollment as a continuous eligibility assignment variable. This design creates a quasi-experimental condition where the only systematic difference between patients enrolling just before and just after treat all policy adoption is the probability of treatment eligibility. There were large increases in rapid ART initiation after national adoption of treat all, with 81.6% of patients initiating ART within 30 days of enrollment after the policy adoption, and little difference in rapid ART initiation across patients with different immunodeficiency status, as measured by CD4 counts. In Burundi, Kenya, Malawi, and Rwanda, there were large and significant increases in rapid ART initiation immediately following national adoption of treat all, ranging from 12.5- and 17.7-percentage-point increases in rapid ART initiation in Malawi and Burundi, respectively, to 25.7- and 34.5-percentage-point increases in Kenya and Rwanda. In Uganda and Zambia, there was no significant increase in rapid ART initiation immediately following national adoption of treat all. However, there were significant increases in the rate of rapid ART initiation in the months following treat all adoption, with each additional month following the policy adoption being associated with 2.2- and 2.6-percentage-point increases in the proportion of patients initiating ART in Uganda and Zambia, respectively. In the period following treat all adoption, men and young adults (aged 16–24 years) were less likely to rapidly initiate ART than women and older adults, respectively. However, for all groups, the risk of failing to rapidly initiate ART significantly decreased with elapsed time after treat all policy adoption. What do these findings mean? Using a regression discontinuity design and real-world service delivery data, primarily from public-sector health facilities, our findings suggest that national adoption of treat all policies has led to appreciable increases in rapid ART initiation. As more follow-up data become available, future research should assess longer-term outcomes, such as retention in care, viral suppression, and treatment failure among patients initiating therapy under treat all.

Cirrhosis commonly complicates portal hypertension worldwide but in Zambia hepatosplenic schistosomiasis (HSS) dominates as the cause of portal hypertension. We need easier and non-invasive ways to assess HSS. Transient elastography (TE), a measure of liver stiffness can diagnose liver cirrhosis. TE remains unexplored in HSS patients, who generally have normal liver parenchyma. We aimed to explore liver stiffness in HSS. This nested case control study was conducted at the University Teaching Hospital, Lusaka, Zambia between January 2015 and January 2016. We enrolled 48 adults with HSS and 22 healthy controls. We assessed liver stiffness using TE while plasma hyaluronan was used to assess liver fibrosis. Plasma tumor necrosis factor receptor 1 (TNFR1) and soluble cluster of differentiation 14 (sCD14) were used to assess inflammation. The median (interquartile range) liver stiffness was higher in patients, 9.5 kPa (7.8, 12.8) than in controls, 4.7 kPa (4.0, 5.4), P < 0.0001. We noted linear correlations of hyaluronan and TNFR1 with the liver stiffness, P = 0.0307 and P = 0.0003 respectively. HSS patients seem to have higher liver stiffness than healthy controls. TE may be useful in identifying fibrosis in HSS. The positive correlations of inflammatory markers with TE suggest that HSS has both periportal and parenchymal pathophysiology., Metabolism; Liver stiffness; Hepatosplenic schistosomiasis; Fibrosis.

Background: Suboptimal retention may undermine the individual and public health benefits of immediate lifelong antiretroviral therapy (ART) for HIV-positive pregnant women (i.e., Option B+). We evaluated the effect of an intervention called the B-plus Enhanced Adherence Package (BEAP) on early ART uptake and short-term retention among newly diagnosed HIV-positive pregnant women in Lusaka, Zambia. Methods: Pregnant women at 3 public sector facilities in Lusaka urban district who were 18+ years old, HIV-positive, and ART naA¯ve were enrolled between March 02, 2017 and December 18, 2017 and randomized 1:1 to BEAP versus standard of care (SOC) services. All participants were eligible for Option B+ per national guidelines. BEAP involved early (within 1-2 weeks of eligibility for option B+) phone calls and home visits from a male-female pair of community health workers (CHW) to provide additional counseling, engage male partners in HIV testing, and follow-up any missed ART appointments. CHW documented all BEAP activities. The primary outcome, initiation and retention on ART per pharmacy records at 30 days after Option B+ eligibility, was compared by study arm in an intention to treat (ITT) analysis using logistic regression. In a per protocol analysis we also assessed the impact of BEAP on initiation and retention among those women who were confirmed to have received BEAP services. In pre-planned subgroup analyses, we also evaluated the BEAP's impact according to participant age, parity, baseline HIV partner disclosure status and baseline CD4+ count. Findings: Among 454 women enrolled, 229 were randomized to BEAP and 225 to SOC. The two arms were balanced with respect to age (p=0.16) and gestational age (p=0.09). Within 30 days of Option B+ eligibility, 445 (98.2%) initiated ART; however, only 369 (82.9%) of those women who started ART were still in care at 30 days. In ITT analysis, the proportion initiating and remaining on ART at 30 days was similar between women randomized to BEAP versus SOC (82.5% versus 80.4%; crude relative risk [RR], 1.03; 95% confidence interval [CI], 0.91-1.16). After exclusion of 92 participants (40.2%) due to not receiving BEAP services based on CHW documentation and 1 participant due to ineligibility, BEAP was associated with being on ART at 30 days versus SOC (91.9.0% versus 80.4%; crude RR 1.14; 95% CI, 1.02-1.29). No significant variation was found in the effect of BEAP in subgroup analyses based on parity, age, baseline HIV disclosure status, and/or baseline CD4+ count. Interpretation: Uptake of Option B+ within 30 days of eligibility was nearly universal among HIV-positive pregnant women in urban Zambia. Women who received the BEAP intervention were statistically more likely to be on ART at 30 days compared to those receiving standard services. This difference, though modest, supports the potential of targeted early interventions to optimize the implementation of Option B+. Trial Registration: The trial was also registered at ClinicalTrials.gov (trials number NCT02459678). Funding Statement: This research has been supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Centers for Disease Control and Prevention (CDC) under the terms of cooperative agreement number U01GH000530. Additional investigator support was provided by the National Institutes of Health (K24 AI120796). Declaration of Interests: MM declares that the Centre for Infectious Disease Research in Zambia (CIDRZ), received a grant from the Centers for Disease Control and Prevention (CDC) (grant number: GH000530) to carry out this study. The rest of the authors declare no conflict of interest. Ethics Approval Statement: Approval for the study was obtained from the University of Zambia Biomedical Research Ethics Committee (Lusaka, Zambia) and the University of North Carolina at Chapel Hill Instituitional Review Board (Chapel Hill, NC, USA). The study was reviewed in accordance with the Centers for Disease Control and Prevention (CDC) human research protection procedures and was determined to be research, but CDC investigators did not interact with human subjects or have access to identifiable data or specimens for research purposes. Women who were eligible and agreed to participate provided written informed consent.

INTRODUCTION: We assessed mortality and losses to follow-up (LTFU) during adolescence in routine care settings in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. METHODS: Cohorts in the Asia-Pacific, the Caribbean, Central, and South America, and sub-Saharan Africa (Central, East, Southern, West) contributed data, and included adolescents living with HIV (ALHIV) enrolled from January 2003 and aged 10 to 19 years (period of adolescence) while under care up to database closure (June 2016). Follow-up started at age 10 years or the first clinic visit, whichever was later. Entering care at /=15 years represented infection acquired during adolescence. Competing risk regression was used to assess associations with death and LTFU among those ever receiving triple-drug antiretroviral therapy (triple-ART). RESULTS: Of the 61,242 ALHIV from 270 clinics in 34 countries included in the analysis, 69% (n = 42,138) entered care /=15 years (81% female). During adolescence, 3.9% died, 30% were LTFU and 8.1% were transferred. For those with infection acquired perinatally versus during adolescence, the four-year cumulative incidences of mortality were 3.9% versus 5.4% and of LTFU were 26% versus 69% respectively (both p < 0.001). Overall, there were higher hazards of death for females (adjusted sub-hazard ratio (asHR) 1.19, 95% confidence interval (CI) 1.07 to 1.33), and those starting treatment at >/=5 years of age (highest asHR for age >/=15: 8.72, 95% CI 5.85 to 13.02), and in care in mostly urban (asHR 1.40, 95% CI 1.13 to 1.75) and mostly rural settings (asHR 1.39, 95% CI 1.03 to 1.87) compared to urban settings. Overall, higher hazards of LTFU were observed among females (asHR 1.12, 95% CI 1.07 to 1.17), and those starting treatment at age >/=5 years (highest asHR for age >/=15: 11.11, 95% CI 9.86 to 12.53), in care at district hospitals (asHR 1.27, 95% CI 1.18 to 1.37) or in rural settings (asHR 1.21, 95% CI 1.13 to 1.29), and starting triple-ART after 2006 (highest asHR for 2011 to 2016 1.84, 95% CI 1.71 to 1.99). CONCLUSIONS: Both mortality and LTFU were worse among those entering care at >/=15 years. ALHIV should be evaluated apart from younger children and adults to identify population-specific reasons for death and LTFU.

Access to hepatitis B viral load (VL) testing is poor in sub-Saharan Africa (SSA) due to economic and logistical reasons.To demonstrate the feasibility of testing dried blood spots (DBS) for hepatitis B virus (HBV) VL in a laboratory in Lusaka, Zambia, and to compare HBV VLs between DBS and plasma samples.Paired plasma and DBS samples from HIV-HBV co-infected Zambian adults were analyzed for HBV VL using the COBAS AmpliPrep/COBAS TaqMan HBV test (Version 2.0) and for HBV genotype by direct sequencing. We used Bland-Altman analysis to compare VLs between sample types and by genotype. Logistic regression analysis was conducted to assess the probability of an undetectable DBS result by plasma VL.Among 68 participants, median age was 34 years, 61.8% were men, and median plasma HBV VL was 3.98logIU/ml (interquartile range, 2.04-5.95). Among sequenced viruses, 28 were genotype A1 and 27 were genotype E. Bland-Altman plots suggested strong agreement between DBS and plasma VLs. DBS VLs were on average 1.59logIU/ml lower than plasma with 95% limits of agreement of -2.40 to -0.83log IU/ml. At a plasma VL ≥2,000IU/ml, the probability of an undetectable DBS result was 1.8% (95% CI: 0.5-6.6). At plasma VL ≥20,000IU/ml this probability reduced to 0.2% (95% CI: 0.03-1.7).In a Zambian laboratory, we observed strong agreement between DBS and plasma VLs and high sensitivity in DBS at plasma VL ≥2,000IU/ml. As HBV treatment expands, DBS could increase access to HBV VL testing and care in SSA settings.

IntroductionWe evaluated antiviral therapy (AVT) eligibility in a population-based sample of adults with chronic hepatitis B virus (HBV) infection in Zambia.Materials and methodsUsing 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.ResultsAcross 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).ConclusionApproximately 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.

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 ( = 160) who were HIV-negative and referred to the hospital after a routine or clinically-driven HBV test were enrolled. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), platelet count, hepatitis B e-antigen, and HBV DNA were measured. Liver fibrosis/cirrhosis was assessed by physical examination, AST-to-platelet ratio index, and transient elastography. In antiviral therapy-naive individuals, we described HBV stages and antiviral therapy eligibility per World Health Organization (WHO) and by HBV test (routine clinical). Elevated ALT was > 19 in women and > 30 U/L in men. Among treatment-experienced individuals, we described medication side effects, adherence, and viral suppression. 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 routine testing (at the blood bank, community events, .). Among 120 treatment-naive individuals, 2.5% were categorized as immune tolerant, 11.7% were immune active, 35.6% were inactive carriers, and 46.7% had an indeterminate phenotype. Per WHO guidelines, 13 (10.8%) were eligible for immediate antiviral therapy. The odds of eligibility were eight times higher for those diagnosed at clinical routine settings (adjusted odds ratio, 8.33; 95%CI: 2.26-29.41). Among 40 treatment-experienced HBV patients, virtually all took tenofovir, and a history of mild side effects was reported in 20%. Though reported adherence was good, 12 of 29 (41.4%) had HBV DNA > 20 IU/mL. CONCLUSION Approximately one in ten HBV-monoinfected Zambians were eligible for antivirals. Many had indeterminate phenotype and needed clinical follow-up.

INTRODUCTION Excessive alcohol consumption leads to unfavourable outcomes in people living with HIV (PLHIV), including reduced adherence to antiretroviral therapy (ART) and engagement into care. However, there is limited information on alcohol consumption patterns among PLHIV in sub-Saharan Africa. METHODS Using a cross-sectional approach, the Alcohol Use Disorders Identification Test (AUDIT-C) was administered to PLHIV attending HIV clinics in Cote d'Ivoire, Togo, Senegal and Zambia (2013 to 2015). Hazardous drinking was defined as an AUDIT-C score ≥4 for men or ≥3 for women, and binge drinking as ≥6 drinks at least once per month. The prevalence of binge drinking was compared to estimates from the general population using data from the World Health Organization. Factors associated with binge drinking among persons declaring any alcohol use in the past year were assessed using a logistic regression model to estimate odds ratio (OR) and their corresponding 95% confidence intervals (CI). RESULTS Among 1824 PLHIV (median age 39 years, 62.8% female), the prevalence of hazardous alcohol use ranged from 0.9% in Senegal to 38.4% in Zambia. The prevalence of binge drinking ranged from 14.3% among drinkers in Senegal to 81.8% in Zambia, with higher estimates among PLHIV than in the general population. Male sex (OR 2.4, 95% CI 1.6 to 3.7), tobacco use (OR 1.7, 95% CI 1.0 to 2.9) and living in Zambia were associated with binge drinking. CONCLUSIONS Alcohol consumption patterns varied widely across settings and binge drinking was more frequent in HIV-positive individuals compared to the general population. Interventions to reduce excessive alcohol use are urgently needed to optimize adherence in the era of universal ART.

INTRODUCTION By 2020, 90% of all people diagnosed with HIV should receive long-term combination antiretroviral therapy (ART). In sub-Saharan Africa, this target is threatened by loss to follow-up in ART programmes. The proportion of people retained on ART long-term cannot be easily determined, because individuals classified as lost to follow-up, may have self-transferred to another HIV treatment programme, or may have died. We describe retention on ART in sub-Saharan Africa, first based on observed data as recorded in the clinic databases, and second adjusted for undocumented deaths and self-transfers. METHODS We analysed data from HIV-infected adults and children initiating ART between 2009 and 2014 at a sub-Saharan African HIV treatment programme participating in the International epidemiology Databases to Evaluate AIDS (IeDEA). We used the Kaplan-Meier method to calculate the cumulative incidence of retention on ART and the Aalen-Johansen method to calculate the cumulative incidences of death, loss to follow-up, and stopping ART. We used inverse probability weighting to adjust clinic data for undocumented mortality and self-transfer, based on estimates from a recent systematic review and meta-analysis. RESULTS We included 505,634 patients: 12,848 (2.5%) from Central Africa, 109,233 (21.6%) from East Africa, 347,343 (68.7%) from Southern Africa and 36,210 (7.2%) from West Africa. In crude analyses of observed clinic data, 52.1% of patients were retained on ART, 41.8% were lost to follow-up and 6.0% had died 5 years after ART initiation. After accounting for undocumented deaths and self-transfers, we estimated that 66.6% of patients were retained on ART, 18.8% had stopped ART and 14.7% had died at 5 years. CONCLUSIONS Improving long-term retention on ART will be crucial to attaining the 90% on ART target. Naive analyses of HIV cohort studies, which do not account for undocumented mortality and self-transfer of patients, may severely underestimate both mortality and retention on ART.

In an HIV-hepatitis B virus (HIV-HBV) coinfection cohort in Zambia, we piloted a qualitative point-of-care (POC) test for urine Ethyl glucuronide (uEtG), assessed concordance between uEtG and alcohol use disorders identification test-consumption (AUDIT-C), and identified epidemiological factors associated with underreporting (defined as uEtG-positivity with last reported drink > 7 days prior). Among 211 participants (40.8% women), there were 44 (20.8%) lifetime abstainers, 32 (15.2%) former drinkers, and 135 (64.0%) current drinkers, including 106 (50.2%) with unhealthy drinking per AUDIT-C. Eighty-seven (41.2%) were uEtG-positive including 64 of 65 (98.5%) who drank ≤ 3 days prior and 17 of 134 (12.7%) underreported, all of whom admitted to recent drinking when results were discussed. uEtG was moderately concordant with AUDIT-C. Past drinking (versus lifetime abstinence) and longer time on antiretrovirals (≥ 12 months) were associated with underreporting. These data support further use of POC alcohol biomarkers in HIV and hepatitis research and clinical settings.

Background Although most African countries offer hepatitis B immunization through a 3-dose vaccine series recommended at 6, 10 and 14 weeks of age, very few provide birth dose vaccination. In support of Cameroon's national plan to implement the birth dose vaccine in 2017, we investigated predictors of infant hepatitis B virus (HBV) vaccination under the current program. Methods Using the 2011 Demographic Health Survey in Cameroon, we identified women with at least one living child (age 12-60 months) and information about the hepatitis B vaccine series. Vaccination rates were calculated, and logistic regression modeling was used to identify factors associated with 3-dose series completion. Changes over time were assessed with linear logistic model. Results Among 4594 mothers analyzed, 66.7% (95% confidence interval [CI]: 64.1-69.3) of infants completed the hepatitis B vaccine series; however, an average 4-week delay in series initiation was noted with median dose timing at 10, 14 and 19 weeks of age. Predictors of series completion included facility delivery (adjusted odds ratio [aOR]: 2.1; 95% CI: 1.7-2.6), household wealth (aOR: 1.9; 95% CI: 1.2-3.1 comparing the highest and lowest quintiles), Christian religion (aOR: 1.8; 95% CI: 1.3-2.5 compared with Muslim religion) and older maternal age (aOR: 1.4; 95% CI: 1.2-1.7 for 10 year units). Conclusions Birth dose vaccination to reduce vertical and early childhood transmission of hepatitis B may overcome some of the obstacles to timely and complete HBV immunization in Cameroon. Increased awareness of HBV is needed among pregnant women and high-risk groups about vertical transmission, the importance of facility delivery and the effectiveness of prevention beginning with monovalent HBV vaccination at birth.

Background We evaluated the field performance of a rapid point-of-care (POC) test for hepatitis B surface antigen (HBsAg) that could support decentralization and scale-up of hepatitis B virus (HBV) diagnosis in Africa. Objective To determine the field performance of the Determine HBsAg POC test for diagnosis of HBV co-infection among HIV patients in Zambia. Study design Between 2013–2014, we screened HIV-infected adults for HBsAg at two urban clinics in Zambia. A subset were tested with the POC Determine HBsAg (Alere, USA) by finger prick in the clinic and HBsAg serology (Access2Analyzer, Beckman Coulter) at a reference laboratory. If either test was reactive, we determined HBV viral load (VL) and genotype. We described patient demographic and clinical characteristics (including liver fibrosis) and assessed the sensitivity, specificity, positive and negative predictive values (PPV and NPV) of the Determine test. In secondary analyses, we assessed sensitivity among patients with replicating HBV (i.e., VL > 20 IU/ml) and with high HBV VL (i.e.,>20,000 IU/ml). Results Among 412 participants with both HBsAg tests, median age was 34 years, 51% were women, and median CD4 was 208 cells/mm3. By serology, 66 (16%) were HBsAg-positive. Overall Determine had 87.9% sensitivity, 99.7% specificity, 98.3% PPV, and 97.7% NPV. Six of 8 patients with false negative results had undetectable HBV VL and no evidence of significant liver fibrosis. Test sensitivity was 95.9% among the 51 with replicating HBV and 100% among the 28 with high HBV VL. Conclusions Determine HBsAg is a cheaper alternative HBV testing option compared to the gold standard ELISA and has high specificity and good sensitivity in the field among HIV-infected individuals.

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