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Background: Successful linkage to HIV services and initiation of antiretroviral treatment (ART) for children living with HIV (CLHIV) is critical to improve pediatric ART coverage. We aimed to assess confirmatory testing, linkage, and rapid ART initiation among newly diagnosed CLHIV in Ethiopia from the perspectives of caregivers and healthcare workers (HCWs). Methods: We conducted standardized surveys with HCWs and caregivers of children 2–14 years who were diagnosed with HIV but not yet on ART who had been identified during a cross-sectional study in Ethiopia from May 2017–March 2018. Eight health facilities based on their HIV caseload and testing volume and 21 extension sites were included. Forty-one children, 34 care givers and 40 healthcare workers were included in this study. Three months after study enrollment, caregivers were surveyed about timing and experiences with HIV service enrollment, confirmatory testing, and ART initiation. Data collected from HCWs included perceptions of confirmatory testing in CLHIV before ART initiation. SPSS was used to conduct descriptive statistics. Results: The majority of the 41 CLHIV were enrolled to HIV services (n = 34, 83%) and initiated ART by three months (n = 32, 94%). Median time from diagnosis to ART initiation was 12 days (interquartile range 5–18). Five children died before the follow-up interview. Confirmatory HIV testing was conducted in 34 children and found no discordant results; the majority (n = 23, 68%) received it within one week of HIV diagnosis. Almost all HCWs (n = 39/40, 98%) and caregivers (n = 31/34, 91%) felt better/the same about test results after conducting confirmatory testing. Conclusion: Opportunities remain to strengthen linkage for newly diagnosed CLHIV in Ethiopia through intensifying early follow-up to ensure prompt confirmatory testing and rapid ART initiation. Additional services could help caregivers with decision-making around treatment initiation for their children. [ABSTRACT FROM AUTHOR]

Background. Studies have shown high early mortality after initiation of highly active antiretroviral therapy (HAART). We examined change in three-year survival and predictors of mortality of patients initiating HAART in Ethiopia since 2007 to 2019. Methods. A retrospective cohort study was conducted in 47 health facilities (HFs) using records of 11,013 adult patients initiating HAART from 2007 to 2019. Study subjects were stratified as four different cohorts based on their calendar year of HAART initiation: 2007-2010, 2011-2013, 2014-2016, and 2017-2019. HFs were selected using probability proportional to size of patients. Survival rate and predictors of mortality were estimated by the calendar year using the Kaplan-Meier and Cox proportional hazard, respectively. We generated a pooled estimate of survival rate and predicators of mortality. Results. Data from 1881, 3868, 3004, and 2260 patients were retrieved from each of the cohorts. Overall mortality for all cohorts at all times was 10.3%. A gradual decline of mortality was observed in the first three years of follow-up since 2007-2016 which were 21.37%, 10.03%, and 4.34% among patients who initiated HAART in 2007, 2011, and 2014 respectively. A mortality jump of 9.25% was observed among patents initiating HAART in 2017, which coincided with political instability happened in the country. Of the 21,638 person-years of follow-up among 11,013 adults, mortality was 5.23/100 person-years, while disaggregated by the cohorts, it was 14.77, 5.06, 2.12, and 4.17 per 100 person-years, respectively. Among all the cohorts, patients with CD4 count of ≤200 cells/mm3, unsuppressed viral load, poor adherence, and drug resistance in all cohorts, respectively, have overall 2.0 (95 % CI = 1.35 − 2.69), 4.66 (95 % CI = 2.53 − 6.72), 6.78 (95 % CI = 3.4 − 10.3), and 10.02 (95 % CI = 6.91 − 13.82) times of mortality risk than those without. Patients with bedridden for cohort initiating HAART during 2007 and 2011 were 2.0 (95 % CI = 1.35 − 2.69) times of mortality risk than those without. Conclusion. Patients initiating HAART from 2007 to 2016 have continuously improved their survival during three-year cohort follow-up in Ethiopia. The significant decline of survival among those who initiate HAART as of 2017 calls for program intervention. Low CD4 counts, unsuppressed viral load, poor adherence, and drug resistance could be used as predictors for increased mortality to monitor the quality of HAART and improve clinical management of HIV/AIDS patients. [ABSTRACT FROM AUTHOR]

Background: Accumulating evidence indicates that schizophrenia is accompanied by significant activation of the immune system; however, there is limited data from low and middle-income countries (LMIC). Inflammatory markers may be more relevant in LMIC settings where infectious conditions are more prevalent and may thus play some role in the causation and maintenance of schizophrenia. The aim of this study was to assess the level of inflammatory markers high sensitive C-reactive protein (hsCRP) and interleukin-6 (IL-6) in patients with schizophrenia. Materials and methods: The study population consisted of a total of 132 study participants; 82 participants with schizophrenia and 50 controls. hsCRP and IL-6 were measured using Cobas Integra 400 Plus and Cobas e 411 analysers respectively. Results: The levels of hsCRP and IL-6 were significantly increased among participants with schizophrenia compared to controls: hsCRP mean value 2.87 ± 5.6 vs 0.67 ± 0.6 mg/L; IL-6 mean value 6.63 ± 5.6 vs 3.37 ± 4.0 pg/ml. Controlling for potential confounders (age, sex and body mass index), having a diagnosis of schizophrenia remained significantly associated with increased hsCRP and IL-6. Conclusion: The results confirm that inflammatory processes may have a role in the pathophysiology of schizophrenia regardless of setting. Despite failure of some interventions with anti-inflammatory properties, interventions to reduce inflammation are still worth pursuing. [ABSTRACT FROM AUTHOR]

Introduction: Hepatotoxicity is one of the risk factors associated with treatment non-adherence, which is the main risk factor for drug resistance. Therefore, this study aimed to determine the incidence and risk factors of hepatotoxicity during highly active antiretroviral therapy (HAART) among people living with HIV in Ethiopia. Methods: A prospective cohort study was conducted between April 2007 and January 2011 at Saint Peter Specialized Hospital, Akaki and Kality Health Centers, Addis Ababa, Ethiopia. A total of 316 HIV-infected adult individuals (70 participants were HIV and TB co-infected and 246 were infected with HIV alone) were included in this study. The study participants were followed for a total of 18 months with or without HAART. Socio-demographic data were collected using a structured questionnaire, and venous blood samples were collected for laboratory tests. Logistic regression and Poisson regression were used to determine the independent effect of each variable on hepatotoxicity at baseline and end of follow-up. Results: Of 316 HIV-infected people, 72 (22.8%) participants had an elevated ALT/AST which was 100% mild-to moderate hepatotoxicity at baseline. Baseline CD4 T-cell count (p = 0.027) and HIV co-infection with TB (p < 0.001) were independently associated with hepatotoxicity at baseline. The overall incidence rate of hepatotoxicity in participants on HAART (21.8 per 100 person-years) was lower than participants who were HAART naïve (33.3 per 100 person-years) (p = 0.009). Conclusion: High incidence of mild-to-moderate hepatotoxicity and low severe hepatotoxicity were observed in HIV-infected individuals who were on HAART or were HAART naïve. HAART may minimize the occurrence of hepatotoxicity. Although HAART could minimize hepatotoxicity among HIV-infected people, to manage mild and moderate hepatotoxicity liver function test monitoring is required. [ABSTRACT FROM AUTHOR]

Highlights • There was a decline by >40% in the prevalence of HIV, HBV, Syphilis and HSV-2 over the past 9–10 years in pregnant women in Ethiopia. • The higher level in the prevalence of the major STIs by 2014, suggest the need to strengthen targeted intervention of STIs in pregnant women. • Age category, study sites/residence and time/years were associated with positive HSV-2 test result. • Future investigation is need to identify factors associated with the epidemiology, synergetic interaction of the STIs. • Future investigation is need also to investigate clinical implication of combined infections (HIV, HBV, HSV-2 and Syphilis). Abstract Objectives This study was performed to determine the trends in seroprevalence of four major sexually transmitted infections (STIs) (HIV, hepatitis B virus (HBV), herpes simplex virus type 2 (HSV-2), and syphilis) over a 10-year period (2005–2014) in pregnant women in Ethiopia. Methods Pregnant women (15–49 years old) who were enrolled in the antenatal care-based national HIV surveillance were included. Serological tests for HIV, HBV, HSV-2, and syphilis were done on serum/plasma samples. Results A total of 4887 pregnant women were included. Results showed a decline in prevalence of these STIs by 40–60% over the 10 years (2005–2014): HIV (10.5% to 5.5%), syphilis (2.5% to 1.1%), HBV (12.6% to 6.7%), and HSV-2 (47.5% to 28.5%). In 2014, 109/4887 (2.2%) women had triple infections. In 2005, 2007, and 2009, the prevalence of HSV-2 in the older age group (35–45 years) (47.1%, 47.4%, and 50.0%, respectively) was higher than that in the younger age group (15–24 years) (40.9%, 19.5%, and 20.2%, respectively). Age category (Chi-square = 22.4, p < 0.001), study sites/residence (Chi-square = 135.2, p = 0.001), and time/years (Chi-square = 58.9, p = 0.001) were associated with a positive HSV-2 test result. Conclusions A decline in HIV, HBV, HSV-2, and syphilis of >40% was seen over the years in Ethiopia. However, an intermediate endemicity level of HBV and higher prevalence of HIV and HSV-2 by 2014, suggest the need to strengthen prevention strategy for STIs. [ABSTRACT FROM AUTHOR]

Background: Ethiopia is one of the sub-Saharan African countries most affected by HIV/AIDS. However, the country lacks data describing the extent of the epidemic among people who inject drugs (PWID). Thus, a bio-behavioural study was conducted in 2015 to generate strategic information on the magnitude of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis and related risk behaviours among PWID in Addis Ababa. Methods: A cross-sectional study using respondent-driven sampling was conducted among people reported to have injected illicit drugs within 6 months before the study. Males and females aged 15 years or above and who were resident in Addis Ababa were included in the study between 26 March and 22 May 2015. Data was analysed using respondent-driven (RDS) Analyst software. Results: A total of 237 participants, including 6 seeds, enrolled in the study; most of the PWID were males (96%) with a mean age of 26 years. Most (79%) of the PWID reported injecting heroin but also reported using non-injecting drugs, including marijuana or ganja (47%) and/or khat (31%). Forty per cent of PWID reported ever sharing needles and 56% reported sharing other injecting equipment. However, only 14% reported injecting daily, and 49% reported injecting only 1 to 3 times a month. HIV prevalence was 6%, HBV was 5.1%, HCV was 2.9% and syphilis 5.1% among PWID. Among HIV-positive PWID, 60% reported sharing a needle the last time they injected. Conclusion: Even though the prevalence of HIV among drug users is not much higher than in the general population in Addis Ababa, the needle sharing prevalence was high. Thus, this baseline study shows the need to establish harm reduction programmes and prevention strategies for the PWID in Addis Ababa. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although there are several studies reported on factors affecting tuberculosis (TB) treatment non-adherence, there is information gap on psychosocial and patients' perceptions aspects. Therefore, this study was aimed to investigate the effect of psychosocial factors and patients' perceptions on TB treatment non-adherence in Ethiopia. METHODS: A cross sectional study was conducted in Addis Ababa from May to December, 2014. Thirty one health facilities were randomly selected and 698 TB patients, who had been on treatment, were enrolled consecutively using patient registration number. Structured questionnaire was used to collect data on demographics, knowledge, psychological distress, alcohol use, tobacco smoking and six HBM domains. Treatment adherence level was the main outcome variable, and it measured using visual analog scale. Statistical Package for Social Sciences version 20 was used for data analysis. RESULTS: Non-adherence level within last one month prior to the study was 19.5%. After controlling for all potential confounding variables, Antiretroviral Therapy (ART) status (Adjusted Odds Ratio (AOR) = 1.79, 95% Confidence interval (CI) (1.09-2.95)), alcohol use (AOR = 2.11, 95% CI (1.33-3.37)), economic status (AOR = 0.53, 95% CI (0.33-0.82)), perceived barriers (AOR = 1.21, 95% CI (1.10-1.47)) and psychological distress (AOR = 1.83, 95% CI (1.47-2.29)) were independently associated with TB treatment non-adherence. CONCLUSION: ART status, economic status, alcohol use, perceived barrier and psychological distress are the major areas that need to be targeted with health promotion intervention to enhance TB treatment adherence. [ABSTRACT FROM AUTHOR]

Introduction: In Ethiopia, CD4+ T-cell counting is still required for all patients at baseline before antiretroviral therapy (ART) and to determine eligibility and follow-up of opportunistic infection prophylaxis. However, access to CD4+ T cell count in rural health facilities remains a major challenge in Ethiopia like other resource-limited settings. Methodology: Both capillary and venous blood was drawn from each of 325 study participant recruited in Addis Ababa and surroundings. The CD4+ T-cell count, CD4%, and hemoglobin (Hgb) were tested at one of the four study health facilities using capillary blood and BD FACSPresto™ device. These tests were also done at the national HIV reference laboratory, using venous blood with BD FACSCalibur™, Sysmex XT-1800i™, and BD FACSPresto™. Results: BD FACSPresto™ had an absolute mean bias of -13.3 cells/ul (-2.99%) and 28.3 cells/μl (6.4%) using venous and capillary blood, respectively, compared with BD FACSCalibur™. The absolute CD4 assay on the BD FACSPresto™ had a regression coefficient (R2) of 0.87 and 0.92 using capillary blood and venous blood samples, respectively, compared with BD FACSCalibur™. The percentage similarity of the BD FACSPresto™ using capillary and venous blood was 105.2% and 99.3%, respectively. The sensitivity of the FACSPresto™ using threshold of 500 cells/μl for ART eligibility using capillary and venous blood was 87.9 and 94.3%, while the specificity was 91.4 and 83.8%, respectively. Furthermore, the BD FACSPresto™ had an absolute mean bias of -0.2 dl/μl (0.0%) (95% LOA: -1.7, 1.3) and -0.59 dl/μl (0.1%) (95% LOA: -1.49, 0.31) for Hgb using capillary and venous blood compared with the Sysmex XT-1800i™, respectively. Conclusion: Our results showed acceptable agreement between the BD FACSPresto™ and BD FACSCalibur™ for CD4+ T-cell counting and CD4%; and between the BD FACSPresto™ and Sysmex XT-1800i™for measuring Hgb concentration. [ABSTRACT FROM AUTHOR]

Background: Despite the large number of TB patients on ART in Ethiopia, their mortality remains high. This study reports the effect of TB on HIV related mortality and determinants of TB/HIV co-infection related mortality. Methods: A longitudinal study design was employed as part of the Advanced Clinical Monitoring of ART (ACM) in Ethiopia. All patients started on ART at or after January 1, 2005 were included. Survival analysis was done to compare survival patterns of HIV patients with TB against HIV patients without TB. In addition, determinants of survival among TB/HIV coinfected patients were analyzed. Adjusted effects of the different factors on time to death were generated using Cox-proportional hazards regression. Results: A total of 3,889 patients were enrolled in the ACM study, of which 355 TB cases were identified, making the crude prevalence 9% (95% CI 8.3 - 10.2). Overall, incidence of TB was 2.2 (95% CI 1.9-2.4) per 100 person-years. TB was highest in the first 2 months and declined with time on ART to reach 1 per 100 person years after 24 months on ART. TB was significantly associated with mortality among HIV patients on HAART (AHR 2.0, 95% CI 1.47-2.75). Male gender was associated with mortality among TB/HIV co-infected patients. Conclusion: Tuberculosis plays a key role in HIV associated mortality. Targeted interventions which can keep patients free of TB in the early stages of their treatment are required to reduce TB related mortality. [ABSTRACT FROM AUTHOR]

Background: Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM). Methodology: A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence. Results: At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18–0.53), p < 0.001)). Conclusion: Psychological counseling and educational interventions, which were guided by HBM, significantly decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy. Trial Registration: Pan African Clinical Trials Registry [ABSTRACT FROM AUTHOR]

Background: HIV/TB coinfection remains a major challenge even after the initiation of HAART. Little is known about Mycobacterium tuberculosis (Mtb) specific immune restoration in relation to immunologic and virologic outcomes after long-term HAART during co-infections with latent and active TB. Methods: A total of 232 adults, including 59 HIV patients with clinical TB (HIV + TB+), 125 HIV patients without clinical TB (HIV + TB-), 13 HIV negative active TB patients (HIV-TB+), and 10 HIV negative Tuberculin Skin TST positive (HIV-TST+), and 25 HIV-TST- individuals were recruited. HAART was initiated in 113 HIV + patients (28 TB + and 85 TB-), and anti-TB treatment for all TB cases. CD4+ T-cell count, HIV RNA load, and IFN-γ responses to ESAT-6/ CFP-10 were measured at baseline, 6 months (M6), 18 months (M18) and 24 months (M24) after HAART initiation. Results: The majority of HIV + TB- (70%, 81%, 84%) as well as HIV + TB + patients (60%, 77%, 80%) had virologic success (HIV RNA < 50 copies/ml) by M6, M18 and M24, respectively. HAART also significantly increased CD4+ T-cell counts at 2 years in HIV + TB + (from 110.3 to 289.9 cells/µl), HIV + TB- patients (197.8 to 332.3 cells/µl), HIV + TST-(199 to 347 cells/µl) and HIV + TST + individuals (195 to 319 cells/µl). Overall, there was no significant difference in the percentage of patients that achieved virologic success and in total CD4+ counts increased between HIV patients with and without TB or LTBI. The Mtb specific IFN-γ response at baseline was significantly lower in HIV + TB + (3.6 pg/ml) compared to HIV-TB + patients (34.4 pg/ml) and HIV + TST + (46.3 pg/ml) individuals; and in HIV-TB + patients compared to HIV-TST + individuals (491.2 pg/ml). By M18 on HAART, the IFN-γ response remained impaired in HIV + TB + patients (18.1 pg/ml) while it normalized in HIV + TST + individuals (from 46.3 to 414.2 pg/ml). Conclusions: Our data show that clinical and latent TB infections do not influence virologic and immunologic outcomes of ART in HIV patients. Despite this, HAART was unable to restore optimal TB responsiveness as measured by Mtb specific IFN-γ response in HIV/TB patients. Improvement of Mtb-specific immune restoration should be the focus of future therapeutic strategies. [ABSTRACT FROM AUTHOR]

Psychological distress is the major comorbidity among tuberculosis (TB) patients. However, its magnitude, associated factors, and effect on treatment outcome have not been adequately studied in low-income countries. This study aimed to determine the magnitude of psychological distress and its effect on treatment outcome among TB patients on treatment. A follow-up study was conducted in Addis Ababa, Ethiopia, from May to December 2014. Patients (N=330) diagnosed with all types of TB who had been on treatment for 1–2 months were enrolled consecutively from 15 randomly selected health centers and one TB specialized hospital. Data on sociodemographic variables and economic status were collected using a structured questionnaire. The presence of psychological distress was assessed at baseline (within 1–2 months after treatment initiation) and end point (6 months after treatment initiation) using the 10-item Kessler (K-10) scale. Alcohol use and tobacco smoking history were assessed using WHO Alcohol Use Disorder Identification Test and Australian Smoking Assessment Checklist, respectively. The current WHO TB treatment outcome definition was used to differentiate the end result of each patient at completion of the treatment. The overall psychological distress was 67.6% at 1–2 months and 48.5% at 6 months after treatment initiation. Multiple logistic regression analysis revealed that past TB treatment history [adjusted odds ratio (AOR): 3.76; 95% confidence interval (CI): 1.67–8.45], being on anti-TB and anti-HIV treatments (AOR: 5.35; 95% CI: 1.83–15.65), being unmarried (AOR: 4.29; 95% CI: 2.45–7.53), having alcohol use disorder (AOR: 2.95; 95% CI: 1.25–6.99), and having low economic status (AOR: 4.41; 95% CI: 2.44–7.97) were significantly associated with psychological distress at baseline. However, at 6 months after treatment initiation, only being a multidrug-resistant tuberculosis (MDR-TB) patient (AOR: 3.02; 95% CI: 1.17–7.75) and having low economic status (AOR: 3.75; 95% CI: 2.08–6.74) were able to predict psychological distress significantly. Past TB treatment history (AOR: 2.13; 95% CI: 1.10–4.12), employment status (AOR: 2.06; 95% CI: 1.06–7.00), and existence of psychological distress symptoms at 6 months after treatment initiation (AOR: 2.87; 95% CI: 1.05–7.81) were found to be associated with treatment outcome. The overall magnitude of psychological distress was high across the follow-up period; this was more pronounced at baseline. At baseline, past TB treatment history, being on anti-TB and anti-HIV treatments, being unmarried, and having symptoms of alcohol use disorder were associated with psychological distress. However, both at baseline and end point, low economic status was associated with psychological distress. Screening and treatment of psychological distress among TB patients across the whole treatment period is needed, and focusing more on patients who have been economically deprived, previously treated for TB, and on MDR-TB treatment are important. [ABSTRACT FROM AUTHOR]

Background: Treatment as prevention evolved into the universal HIV test-and-treat (UTT) strategy, which entails testing to the general population and treatment to every people living with HIV. We investigated universal testing (UT) performance and its determinants in urban Ethiopia and explore magnitude of late diagnosis and its impact on disease stages. Method: We used data from the Ethiopia Population Based HIV Impact assessment (EPHIA), conducted in 2017/2018 which was a cross-sectional and household-based study. For current analysis, we considered self-report first diagnosis to estimate universal testing irrespective of their serostatus and also consider HIV LAg avidity vs viral load vs plasma antiretroviral drug level algorithm to categorize the late diagnosis. We finally evaluate disease stages using CD4 count and viral load. A 2-level multilevel mixed-effect logistic regression model was employed. The effects of individual-level predictors were quantified by the estimates from the fixed-effect part of the model with p-value < 0.05. Result: Data were collected from 18,926 adults among those 29.4% of people living in Urban Ethiopia were never tested for HIV. Never tested females was 26.4% (95% CI = 25.3; 27.5). Never tested among divorced and widowed were 19.4% (95% CI: 17.3; 21.8) and 28.3% (95% CI: 24.6; 32.2), respectively. Never tested among elderly and youth were high (28.3% among 45–54 years old) to (41.2% among 55–64 years old) to 47.8% among 15–24 years old. Overall, late HIV diagnosis among adults in urban Ethiopia was 25.9% (95% CI: 21.7, 30.2). Late diagnosis varies by region ranged from 38.1% in the Gambella to 5.8% in Benishangul Gumuz. Advanced immune suppression (CD4 count < 350 cells/µl) among newly diagnosed long-term infection were significantly higher compared to those who were recently infected which accounted 47.8% (95%CI = 33.2–52.1) and 30.9% (95%CI = 21.3–32.2), respectively. Moreover, Viral load suppression were significantly lower among those who were late diagnosed 26.1% (95%CI = 13.6–33.8) compared to those of newly infected 89.6% (95%CI = 76.2; 93.4). Conclusion: With the aim of UT for high risk and priority population, the low rate of HIV testing among widowed, elderly, young adolescent and women in urban Ethiopia calls for enhanced HIV testing. Moreover, the low HIV testing and high late diagnosis among the high-burden regions calls for region-specific intervention. Advanced disease stages as a result of the high proportion of late diagnosis may impact on fueling community transmission and hinder treatment outcome among PLHIV. [ABSTRACT FROM AUTHOR]

• There is a sharp decline in on-time antiretroviral drug pickup practice among people taking antiretroviral therapy in Ethiopia, across the consecutive six round HIV drug resistance early warning indicators (EWI) surveys (2008–2015). Moreover, drug supply continuity is declining over time in the same rounds of the survey period. • HFs dispensing practice was consistently excellent across all six rounds of HIV drug resistance EWIs surveys. Moreover, patient retention in care is improving over time. • EWIs vary by HFs and administrative regions in Ethiopia. The aim of this study was to assess status of early warning indicators (EWIs) for HIV drug resistance in Ethiopia. A retrospective cohort study was conducted among 90 health facilities (HFs) in 2015. Data were abstracted for 'on time pill pickup' (EWI-I), ' Retention in care' (EWI-II), 'drug supply continuity' (EWI-III) and ' dispensing practices' (EWI-IV). Data analysis was conducted using WHO Excel tool and SPSS V20. EWI-IV was excellent across all of the six rounds of EWI surveys conducted between 2008 and 2015. There were improvements in EWI-II over time from 55.6% to 81%. However, EWI-I and EWI-III declined from 86.7% to 31% and 100% to 41%, respectively. During 2015, half of the HFs in Gambella, Amhara and Southern Nation, Nationalities and people regional (SNNPR) states achieved excellent performance for EWI-I. Similarly, all HFs in Afar, Amhara, Dire Dawa, Harari and Tigray regions achieved excellent performance for EWI-II. There were also differences by level of HFs for EWI-III ; 62% of hospitals and 28% of health centers were out of stock of one or more ARV drugs by 2015. Excellent performance of EWI-IV and improvement of EWI-II over time shall be maintained. The program shall further work to ensure medication adherence and supply continuity. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate HIV-1 drug resistance among patients failing first-line antiretroviral therapy in Ethiopia., Methods: A total of 699 adults infected with HIV (aged ≥15 years) who failed first-line Antiretroviral Therapy (ART) were recruited between 2017 and 2019 from 63 ART-providing sites in Ethiopia. Treatment failure was defined as patients with two consecutive viral loads (VLs) ≥1000 copies/mL within six months of follow-up. The pol gene region of HIV-1 was amplified and sequenced using an in-house assay of the Chinese Center for Disease Prevention and Control. The Stanford HIVDB v9.0 algorithm was used for identification of resistance mutations. Resistance mutations were characterized according to the 2019 International AIDS Society-USA mutation list. P values of <0.05 were considered statistically significant during multivariate analysis, which was done using SPSS v26.0 (SPSS Inc., Chicago, IL)., Results: Overall, HIV drug resistance (HIVDR) among patients failing first-line therapy in Ethiopia was 77.8%. Non-nucleoside/tide reverse transcriptase inhibitors (NNRTI) and NRTI resistance were 75.7% and 71.2%, respectively. Neverapine (NVP) and Efavirenz (EFV) accounted for 74.2% and 60.8% of HIVDR, respectively. About half (48.1%) of NRTI-associated mutations were responsible for Abacavir resistance, while 34% were responsible for multi-NRTI resistance. Mutations responsible for resistance to the commonly used EFV and NVP accounted for 62.9%, while resistance to Etravirine, Doravirine, and Rilivirine, which were not part of the country's ART program, were 37.1%, and can be explained by cross-resistance within the drug class. Protease Inhebitor(PI)associated resistance was detected in only 1.6% of the study's participants. The most common mutations identified were M184V (30.1%), K103N (18.7%), Y181C (13.6%), and K65R (12.1%). In a multivariate logistic regression analysis, predictors of HIVDR were prior ART exposure (adjusted odds ratio [AOR] = 2.3; 95% confidence interval [CI] = 1.8, 3.6), absence of HIV status disclosure (AOR=2.05; 95%CI=1.26, 3.35), CD4 count of ≤200 cells/mm 3 (AOR=1.94; 95%CI=1.21, 3.12), and bedridden status (AOR = 4.16; 95% CI = 3.21, 5.16)., Conclusion: The high-levels of HIVDR among patients with failure of first-line ART in Ethiopia calls for individualized HIVDR testing. Mutations associated with multi-NRTI and NNRTI cross-resistance may alert the program for considering drugs of higher genetic barrier targeting protease and other regions. Patients with low CD4 count and those who are bedridden should be given special attention for the potential development of HIVDR during clinical management., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Implementing effective and efficient case-finding strategies is crucial to increasing pediatric antiretroviral therapy coverage. In Ethiopia, universal HIV testing is conducted for children presenting at high-risk entry points including malnutrition treatment, inpatient wards, tuberculosis (TB) clinics, index testing for children of positive adults, and referral of orphans and vulnerable children (OVC); however, low positivity rates observed at inpatient, malnutrition and OVC entry points warrant re-assessing current case-finding strategies. The aim of this study is to develop HIV risk screening tool applicable for testing children presenting at inpatient, malnutrition and OVC entry points in low-HIV prevalence settings., Methods: The study was conducted from May 2017-March 2018 at 29 public health facilities in Amhara and Addis Ababa regions of Ethiopia. All children 2-14 years presenting to five high-risk entry points including malnutrition treatment, inpatient wards, tuberculosis (TB) clinics, index testing for children of positive adults, and referral of orphans and vulnerable children (OVC) were enrolled after consent. Data were collected from registers, medical records, and caregiver interviews. Screening tools were constructed using predictors of HIV positivity as screening items by applying both logistic regression and an unweighted method. Sensitivity, specificity and number needed to test (NNT) to identify one new child living with HIV (CLHIV) were estimated for each tool., Results: The screening tools had similar sensitivity of 95%. However, the specificities of tools produced by logistic regression methods (61.4 and 65.6%) which are practically applicable were higher than those achieved by the unweighted method (53.6). Applying these tools could result in 58‒63% reduction in the NNT compared to universal testing approach while maintaining the overall number of CLHIV identified., Conclusion: The screening tools developed using logistic regression method could significantly improve HIV testing efficiency among children presenting to malnutrition, inpatient, and OVC entry points in Ethiopia while maintaining case identification. These tools are simplified to practically implement and can potentially be validated for use at various entry points. HIV programs in low-prevalence countries can also further investigate and optimize these tools in their settings., (© 2022. The Author(s).)

Background: Limited data in low HIV prevalence settings such as Ethiopia limit policy development and implementation of optimized pediatric testing approaches to close the treatment gap. This study aimed to determine HIV prevalence, testing yield and factors associated with HIV among children at 5 entry points., Methods: We conducted a cross-sectional study from May 2017 to March 2018 in 29 public health facilities in Amhara and Addis Ababa regions in Ethiopia. Children 2-14 years were enrolled through 5 entry points. Data were obtained from registers, medical records and interviews with caregivers. HIV prevalence and testing yields were calculated for each entry point. Mixed-effects logistic regression analysis identified factors associated with undiagnosed HIV., Results: The study enrolled 2166 children, of whom 94 were HIV positive (40 newly diagnosed). HIV prevalence and testing yield were the highest among children of HIV-positive adults (index testing; 8.2% and 8.2%, respectively) and children presenting to tuberculosis clinics (7.9% and 1.8%) or with severe malnutrition (6.5% and 1.4%). Factors associated with undiagnosed HIV included tuberculosis or index entry point [adjusted odds ratio (aOR), 11.97; 95% CI 5.06-28.36], deceased mother (aOR 4.55; 95% CI 1.30-15.92), recurrent skin problems (aOR 17.71; 95% CI 7.75-40.43), severe malnutrition (aOR 4.56; 95% CI 2.04-10.19) and urban residence (aOR 3.47; 95% CI 1.03-11.66)., Conclusions: Index testing is a critical strategy for pediatric case finding in Ethiopia. Strategies and resources can prioritize minimizing missed opportunities in implementing universal testing for very sick children (tuberculosis, severe malnutrition) and implementing targeted testing in other entry points through use of factors associated with HIV., Competing Interests: This research was supported by the US President’s Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention under the terms of Cooperative Agreement No. 1U2GGH001039. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies. The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Accumulating evidence indicates that schizophrenia is accompanied by significant activation of the immune system; however, there is limited data from low and middle-income countries (LMIC). Inflammatory markers may be more relevant in LMIC settings where infectious conditions are more prevalent and may thus play some role in the causation and maintenance of schizophrenia. The aim of this study was to assess the level of inflammatory markers high sensitive C-reactive protein (hsCRP) and interleukin-6 (IL-6) in patients with schizophrenia., Materials and Methods: The study population consisted of a total of 132 study participants; 82 participants with schizophrenia and 50 controls. hsCRP and IL-6 were measured using Cobas Integra 400 Plus and Cobas e 411 analysers respectively., Results: The levels of hsCRP and IL-6 were significantly increased among participants with schizophrenia compared to controls: hsCRP mean value 2.87 ± 5.6 vs 0.67 ± 0.6 mg/L; IL-6 mean value 6.63 ± 5.6 vs 3.37 ± 4.0 pg/ml. Controlling for potential confounders (age, sex and body mass index), having a diagnosis of schizophrenia remained significantly associated with increased hsCRP and IL-6., Conclusion: The results confirm that inflammatory processes may have a role in the pathophysiology of schizophrenia regardless of setting. Despite failure of some interventions with anti-inflammatory properties, interventions to reduce inflammation are still worth pursuing., (© 2021. The Author(s).)

Background: Validation of previously identified candidate biomarkers and identification of additional candidate gene expression profiles to facilitate diagnosis of tuberculosis (TB) disease and monitoring treatment responses in the Ethiopian context is vital for improving TB control in the future., Methods: Expression levels of 105 immune-related genes were determined in the blood of 80 HIV-negative study participants composed of 40 active TB cases, 20 latent TB infected individuals with positive tuberculin skin test (TST+), and 20 healthy controls with no Mycobacterium tuberculosis (Mtb) infection (TST-), using focused gene expression profiling by dual-color Reverse-Transcription Multiplex Ligation-dependent Probe Amplification assay. Gene expression levels were also measured six months after anti-TB treatment (ATT) and follow-up in 38 TB patients., Results: The expression of 15 host genes in TB patients could accurately discriminate between TB cases versus both TST+ and TST- controls at baseline and thus holds promise as biomarker signature to classify active TB disease versus latent TB infection in an Ethiopian setting. Interestingly, the expression levels of most genes that markedly discriminated between TB cases versus TST+ or TST- controls did not normalize following completion of ATT therapy at 6 months (except for PTPRCv1, FCGR1A, GZMB, CASP8 and GNLY) but had only fully normalized at the 18 months follow-up time point. Of note, network analysis comparing TB-associated host genes identified in the current HIV-negative TB cohort to TB-associated genes identified in our previously published Ethiopian HIV-positive TB cohort, revealed an over-representation of pattern recognition receptors including TLR2 and TLR4 in the HIV-positive cohort which was not seen in the HIV-negative cohort. Moreover, using ROC cutoff ≥ 0.80, FCGR1A was the only marker with classifying potential between TB infection and TB disease regardless of HIV status., Conclusions: Our data indicate that complex gene expression signatures are required to measure blood transcriptomic responses during and after successful ATT to fully diagnose TB disease and characterise drug-induced relapse-free cure, combining genes which resolve completely during the 6-months treatment phase of therapy with genes that only fully return to normal levels during the post-treatment resolution phase., Competing Interests: The authors have declared that no competing interests exist.

Background: The HIV-1 epidemic in Ethiopia has been shown to be dominated by two phylogenetically distinct subtype C clades, the Ethiopian (C'-ET) and East African (C-EA) clades, however, little is known about the temporal dynamics of the HIV epidemic with respect to subtypes and distinct clades. Moreover, there is only limited information concerning transmission of HIV-1 drug resistance (TDR) in the country., Methods: A cross-sectional survey was conducted among young antiretroviral therapy (ART)-naïve individuals recently diagnosed with HIV infection, in Gondar, Ethiopia, 2011-2013 using the WHO recommended threshold survey. A total of 84 study participants with a median age of 22 years were enrolled. HIV-1 genotyping was performed and investigated for drug resistance in 67 individuals. Phylogenetic analyses were performed on all available HIV sequences obtained from Gondar (n = 301) which were used to define subtype C clades, temporal trends and local transmission clusters. Dating of transmission clusters was performed using BEAST., Result: Four of 67 individuals (6.0%) carried a HIV drug resistance mutation strain, all associated with non-nucleoside reverse transcriptase inhibitors (NNRTI). Strains of the C-EA clade were most prevalent as we found no evidence of temporal changes during this time period. However, strains of the C-SA clade, prevalent in Southern Africa, have been introduced in Ethiopia, and became more abundant during the study period. The oldest Gondar transmission clusters dated back to 1980 (C-EA), 1983 (C-SA) and 1990 (C'-ET) indicating the presence of strains of different subtype C clades at about the same time point in Gondar. Moreover, some of the larger clusters dated back to the 1980s but transmissions within clusters have been ongoing up till end of the study period. Besides being associated with more sequences and larger clusters, the C-EA clade sequences were also associated with clustering of HIVDR sequences. One cluster was associated with the G190A mutation and showed onward transmissions at high rate., Conclusion: TDR was detected in 6.0% of the sequenced samples and confirmed pervious reports that the two subtype C clades, C-EA and C'-ET, are common in Ethiopia. Moreover, the findings indicated an increased diversity in the epidemic as well as differences in transmission clusters sizes of the different clades and association with resistance mutations. These findings provide epidemiological insights not directly available using standard surveillance and may inform the adjustment of public health strategies in HIV prevention in Ethiopia., Competing Interests: The authors have declared that no competing interests exist.

Background: Males are more susceptible than females to infections due to the differences in endocrine-immune interactions. Furthermore, it is reported that lowering cell cholesterol impairs viral replication and infection in vitro. However, the production of oxysterols in vivo by oxidation of cholesterol may result in inhibition of HIV replication. Therefore, this study was designed to determine the associations of gender and serum total cholesterol with CD4+ T cell counts and/or WHO clinical stages, and HIV ribonucleic acid (RNA) load in antiretroviral therapy (ART) naive study population with known sero-positive time of stay in Addis Ababa.  METHODS: A cross-sectional study was conducted from February to August 2013 on 594 HIV-1 infected ART-naïve adult study participants in four hospitals Addis Ababa. CD4+ T-cell count, HIV RNA load, hemoglobin and fasting serum total cholesterol were determined. Socio-demographic characteristics, WHO clinical stages, and height and weight were collected from patients' chart and triangulated by structured questionnaire. Pearson chi-square test, Spearman rank correlation and univariate and multivariate linear/logistic regression analyses were carried out to determine associations., Results: Mean HIV RNA load was found to be lower in women than in men (p < 0.05). CD4+ T cell count and serum total cholesterol were found to be significantly correlated with HIV RNA load (p < 0.01). Women were at lower risk of having higher HIV RNA load in comparison to men. In addition, having lower concentrations of serum total cholesterol was found to be independent predictor of higher HIV RNA load in comparison to those with higher concentrations of cholesterol in serum (p < 0.05). The multivariate binomial logistic regression also showed that the immune status was better in women than men, and in the presence of higher serum total cholesterol (p < 0.05)., Conclusion: Gender and serum total cholesterol were found to be associated and independent predictors of HIV RNA load, and CD4+ cell count and/or WHO clinical stages. There is a significant lower HIV RNA load and better CD4+ T cell count in women and those study participants with higher serum total cholesterol.

Background: HIV associated anaemia is always overseen and it could be a challenge for prognosis of patients who are taking ART. The prevalence of anemia due to HIV at the early stage of infection is more prevalent than in the late stage. Knowing the impact of HIV on the haematopotosis of HIV infected patients is very essential for the management and care of people living with HIV/AIDS. HIV related anemia decreases the quality of life and survival rate of HIV patients., Objective: The aim of this study is to determine prevalence of HIV associated anaemia before and after initiation of antiretroviral therapy (ART) in HIV infected adults., Method: A retrospective record review was conducted on HIV infected patients before ART and had follow up at the ART Clinic of Minilik II Hospital Addis Ababa, Ethiopia. Haemoglobin measurement and CD4+ T cell count was measured using standard methodology at baseline and after 4 months of antiretroviral therapy (ART). Paired t -test was used to assess mean differences for haemoglobin and CD4+ T cell count before and after ART initiation., Results: Of the 230 study subjects 121 (52.6%) were anemic before ART. However, the prevalence of anemia after ART (37.4%) was significantly decreased (p < 0.05). The prevalence of anemia was higher in females than in males at base line (70.25% vs. 29.75%) (P = 0.017), and after ART treatment (69.23% vs. 30.77%) (P = 0.000). Mean CD4 cell count of study subjects was 112 cells/microl +/- 67/microl at baseline. The mean CD4+ T cell count is significantly increased after ART and found to be 211 cells/microl +/- 120/microl (p < 0.05). Significance association was observed between Hb aind CD4+ T cell count after ART (P = 0.011)., Conclusions: There was a decline in the prevalence of anemia and increment of mean CD4+ T cell count among HIV infected patients after ART. However, a number of HIV/AIDS patients had still anemia and their CD4+ T cell count is not improved. Thus, there should be a large scale and longitudinal study for further characterization of HIV related anemia.

Background: Human Herpes Virus (HHV-8) is related to Kaposi Saracoma, an opportunistic infection occurring with HIV infection. Little is known about the seroepidemiology of Human Herpesvirus 8 (HHV-8) infection among Ethiopian women, even though women are a major HIV risk group in Ethiopia., Objectives: This study aimed at determining the seroprevalence of HHV-8 infection in HIV-1-infected and uninfected pregnant women in five selected regions of Ethiopia., Methods: A cross-sectional study was conducted from December 2006 to June 2007 where pregnant women were recruited after age-matching in groups. A total of 400 pregnant women were enrolled, with 200 being HIV-infected and 200 being HIV-uninfected Sera were screened for IgG lytic antibody to HHV-8 using an Indirect Fluorescence Assay (IFA) in Virology Unit of Ethiopian Health and Nutrition Research Institute (EHNR1)., Results: Of 400 pregnant women attending antenatal clinic (ANC) testing sites of five regions in Ethiopia, 212 (53.0%) were positive for HHV-8 IgG lytic antibody. There was a high prevalence of HHV-8 infection among HIV-1-infected pregnant women (138, 69.0%) as compared with HIV-1-uninfected pregnant women (74, 37.0%)., Conclusion: The study shows a high prevalence of HHV-8 infection among HIV-1-infected pregnant women as compared with HIV-1-uninfected pregnant women. Therefore, creating awareness and educating women on safe sexual practice and avoiding deep kissing may be a fundamental ways to limit the roots of transmission. Moreover, initiating strong antiretroviral therapy (ART) for HIV infected women would be best treatment prior to the development of Kaposi's sarcoma (KS).

Objective: Evaluation and monitoring of Human Immunodeficiency Virus (HIV) testing reagents at the point of service is helpful to prevent the occurrence of problems related to testing and interpretation. To evaluate the implementation of HIV rapid test kits at the point of services in voluntarily counseling and testing (VCT) and diagnostic centers in Ethiopia., Methods: The assessment was the third phase of evaluation of HIV rapid test kits in Ethiopia followed from phase-I and phase-II. Known proficiency testing panels, well-structured questionnaire (addressing type of tests, human resource and problems related to tests), onsite supervision and retesting of samples collected from sites were used to evaluate the performances of reagents and laboratories., Results: Forty-four health institutions were included. Thirty-six (90.0%) health institutions had trained human resource on HIV testing. In 27 (61.4%) three types of HIV rapid test kits (Determine, Capillus and Unigold) were available. Serial-algorithm was used in all the laboratories. In 31 (70.4%) of them external quality control specimens were not used. Twenty two (50.0%) of the laboratories reported frequent shortage of reagents. All (100%) were able to identify negative specimens distributed. Positive proficiency panel samples were identified in 37 (94.8%) of the 39 laboratories. There was 98.3% agreement at a screening level between the sites and the central laboratory. Rate of discrepancy between screening and confirmatory assays was found to be 3.0% and 2.1% at the sites and at central laboratory, respectively., Conclusion: The test kits showed a good performance at the point of services in the field sites. However, continuous assessment of HIV test kits at the point of service and training of professionals on newly arrived techniques are recommended to have effective testing performance with acceptable sensitive and specific testing algorithm. Effective quality assurance program should be in place to support programs such as VCT, prevention of mother-to-child-transmission and antiretroviral therapy.

We investigated the absolute counts of CD4+, CD8+, B, NK, and CD3+ cells and total lymphocytes in patients with acute Plasmodium falciparum and Plasmodium vivax malaria. Three-color flow cytometry was used for enumerating the immune cells. After slide smears were stained with 3% Giemsa stain, parasite species were detected using light microscopy. Data were analyzed using STATA and SPSS software. A total of 204 adults of both sexes (age, >15 years) were included in the study. One hundred fifty-eight were acute malaria patients, of whom 79 (50%) were infected with P. falciparum, 76 (48.1%) were infected with P. vivax, and 3 (1.9%) were infected with both malaria parasites. The remaining 46 subjects were healthy controls. The leukocyte count in P. falciparum patients was lower than that in controls (P=0.015). Absolute counts of CD4+, CD8+, B, and CD3+ cells and total lymphocytes were decreased very significantly during both P. falciparum (P<0.0001) and P. vivax (P<0.0001) infections. However, the NK cell count was an exception in that it was not affected by either P. falciparum or P. vivax malaria. No difference was found in the percentages of CD4, CD8, and CD3 cells in P. falciparum or P. vivax patients compared to controls. In summary, acute malaria infection causes a depletion of lymphocyte populations in the peripheral blood. Thus, special steps should be taken in dealing with malaria patients, including enumeration of peripheral lymphocyte cells for diagnostic purposes and research on peripheral blood to evaluate the immune status of patients.