Improving Male Partner Involvement in HIV-Positive Women's Care Through Behavioral Change Interventions in Malawi (WeMen Study): A Prospective, Controlled Before-and-After Study

: Several strategies and interventions have been implemented to improve male partner involvement (MI) in Sub-Saharan Africa, but evidence on successful interventions is scarce. This controlled before-and-after intervention study aims to evaluate the impact of three interventions on male partners' involvement in HIV+ women's care in Malawi. We piloted these three interventions: the organization of a special day for men, the deployment of male champions in communities to increase awareness on MI, and the delivery of an incentive (food package) for couples attending the facility. We observed a significant increase in the number of women accompanied by their partners (from 48.5 to 81.4%) and the number of women feeling safe at home (from 63.5 to 95.2%) after the special day intervention. This outcome increased after the deployment of male champions in communities (from 44.0 to 75.0%). No significant improvement was observed in the site where we delivered the incentive to couples. Our findings showed that the special day for men and the use of male champions might effectively increase the male involvement in the health of their female partners

Low mortality rates at two years in HIV-infected individuals undergoing systematic tuberculosis testing with rapid assays at initiation of antiretroviral treatment in Mozambique

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Early detection of poor glycemic control in patients with diabetes mellitus in sub-Saharan Africa: a cohort study in Mozambique

Introduction: WHO estimates 422 million cases of diabetes mellitus worldwide. Mozambique has the second-highest mortality related to DM in the African region. Objectives: To provide data about a DM care service in Mozambique and to evaluate early outcomes of treatment. Methods: The new patients diagnosed with DM in a two-years period in a health centre in Maputo (Mozambique) were included in a retrospective cohort study. Fasting blood glucose (FBG), waist circumference (WC) and BMI were collected at baseline and after three months. Results: 188 patients were enrolled. Median BMI, WC and FBG at baseline were respectively 28 kg/m2(Inter Quartile Range [IQR]23.4-31.8), 98cm (IQR 87-105) and 209mg/dL (IQR 143-295). A non-pharmacological intervention was prescribed for six patients, while 182 patients received metformin 500 mg b.i.d. FBG was significantly reduced at control (226[±103.7]mg/dL vs 186[±93.2]mg/dL, p<0.000); however, glycemic control was reached in 74 patients (39.4%); not controlled patients changed regimen. Elderly patients had a higher glycemic control (adjusted Odds Ratio 2.50, 95% CI 1.11-5.06, p=0.002). Conclusion: Strategies for early detection of scarce glycemic control are feasible in Mozambique and could lead to prompt regimen switch; an invasive therapeutic approach could be preferable in selected cases to achieve control. Keywords: Diabetes Mellitus; Non-Communicable Diseases; Health Care

Epidemiology of Hypoalbuminemia in Hospitalized Patients: A Clinical Matter or an Emerging Public Health Problem?

Serum albumin levels are strongly associated with the morbidity, prognosis, and mortality rates of patients with hypoalbuminemia, which is a frequent problem during hospitalization. An observational retrospective study was carried out to analyze changes in albumin levels in hospitalized patients at the "Fondazione Policlinico Tor Vergata-PTV" in 2018. The prevalence of preexisting hypoalbuminemia at the time of discharge from hospital was investigated using a sample of 9428 patients. Information was collected from the discharge files recorded in the central informatics system of the hospital. Analysis of albumin levels at admission and at discharge was conducted by classes of albuminemia and then stratified by age. At the time of admission, hypoalbuminemia was found to be present in more than half of the sample, with no sex differences. The serum albumin level tended to decrease with age, with pathologic levels appearing from 50 years and progressive worsening thereafter. The condition of marked and mild hypoalbuminemia was more prevalent in patients over 65 years of age. Our findings suggest that hypoalbuminemia should be considered a dangerous condition in itself and a serious public health problem. We aimed to emphasize the role of albumin as useful marker of the in-hospital malnutrition and frailty, to be integrated in the routinely assessment of patients for reconsidering ad hoc healthcare pathways after discharge from hospital, especially when dealing with fragile populations

Dried blood spots for the quantitative evaluation of IgG isotypes and correlation with serum samples in HIV-exposed uninfected (HEU) infants

Background: The determination of IgG levels and their subclasses can provide clinically relevant information on the status of the immune system. Here we determined the sensitivity and reproducibility of the quantification of IgG subclasses from Dried Blood Spots (DBS) in Malawian uninfected infants exposed to HIV (HEU). Methods: Sixty paired samples of serum and DBS from HEU infants were used. Samples were collected from 1, 6, and 24-month old infants. IgGs concentrations from both serum and DBS were analyzed by BN ProSpec Siemens assay, using a different setting for sample dilutions. The reproducibility of the DBS method was tested on 10 samples run twice, starting from the DBS extraction process. To assess the systematic, proportional, and random differences, we computed the Passing-Bablok regression, and the Bland-Altman analysis to estimate the total mean bias between the two tests. Results: The IgG isotypes concentrations from serum and DBS showed significant differences in all the comparisons. Generally, the DBS method underestimated IgG subclasses' values showing a recovery range between 51.2% and 77.6%. Passing Bablok regression on age-based groups showed agreement for IgG, IgG1, and IgG2, but not for IgG3 and IgG4. The mean bias obtained with the Bland Altman test varied largely depending on IgG isotypes (−0.02–2.21 g/l) Coefficient of variation <7.0% was found in the repeated tests for IgG, IgG1, IgG3, and IgG4, while it was 12.4% for IgG2. Conclusions: Varying degrees of differences were seen in the IgGs measurement in the two different matrices. In IgGs analysis, the DBS method offers promise for population-based research, but the results should be carefully evaluated and considered as a relative value since they are not equivalent to the serum concentrations

High-sensitivity C-reactive protein in HIV care: Tuberculosis diagnosis and short-term mortality in a cohort of Kenyan HIV patients in the DREAM programme.

Objective: Tuberculosis (TB) is the leading cause of death in HIV-positive people. In Kenya, 140 000 new TB cases occurred in 2019, and 13 000 HIV-positive patients died due to TB. The objective of this study was to investigate the role of high-sensitivity C-reactive protein (HS-CRP) in TB diagnosis and the prediction of mortality in HIV-positive patients. Methods: The IDEA-TB Study enrolled HIV-positive adult patients attending three DREAM centres in Kenya who were suspected of having TB. A lateral flow urine lipoarabinomannan assay (LF-LAM), serum HS-CRP, and GeneXpert MTB/RIF assay (Xpert MTB/RIF) were performed. Six-month survival was evaluated. Results: A total of 574 patients were enrolled. The median (interquartile range) age, body mass index, and CD4 count were 45 years (37–54 years), 20.5 kg/m2 (18.5–23.69 kg/m2), and 477 cells/mL (290–700 cells/mL), respectively. TB was confirmed in 87 (15.2%) patients. Concordance between the Xpert MTB/RIF and LF-LAM tests was 87.1%. HS-CRP was higher in TB patients (35.39 mg/l vs 9.21 mg/l). Malnutrition and elevated HS-CRP were associated with TB: odds ratio (OR) 2.5 (95% confidence interval (CI) 1.14–5.72) and OR 6.6 (95% CI 3.87–11.52), respectively. Nine (1.6%) patients died during follow-up. No single factor was associated with mortality. Only the combination of malnutrition and elevated HS-CRP was highly predictive of death (odds ratio (OR) 9.8, 95% CI 1.88–50.95); the association was stronger in TB patients (33.3% vs 1.0%; OR 47.6, 95% CI 7.03–322.23). Conclusion: TB diagnosis in HIV-positive patients remains challenging. HS-CRP could play a role in predicting early mortality in symptomatic patients

Evaluation of nutritional conditions, haemoglobin levels, retention in care and viral suppression in a cohort of HIV-infected Malawian adolescents undergoing a one-year tailored intervention within the Diseases Relief through Excellence and Advanced Means

Background. The United Nations Children's Fund (UNICEF) reported that ~1 770 000 adolescents were living with HIV infection in 2017, of whom >80% were in sub-Saharan Africa. In Malawi, ~25 000 boys and 46 000 girls are infected with HIV. Objective. The present study aimed to evaluate a specific adolescent-friendly service implemented in a Diseases Relief through Excellence and Advanced Means (DREAM) health centre in Malawi. Methods. All HIV-positive patients aged 10 - 19 years in the care of the DREAM centre in Blantyre on 17 December 2016 were included in the study and followed-up until 1 January 2018. The service was organised for one adult-free day, with some side activities managed by a co-ordinator and youth leaders. Assessments were performed at the end of the period (EOP). Results. On 17 December 2016, 425 patients were enrolled in the study. Follow-up status at EOP was 403 (94.8%) patients in care, 7 (1.6%) lost to follow-up (LTFU), 2 (0.5%) died and 13 (3.1%) were transferred to other facilities. Death and LTFU rates were 0.72/100 and 2.9/100 person-years, respectively. Moreover, 50.6% (n=198/391) of patients had an improvement in body mass index (BMI)-for-age z-scores, and 70.2% ( n =33/47) of patients who were malnourished at baseline improved (higher improvement in older patients). Mean (standard deviation (SD)) haemoglobin levels increased from 12.5 (1.5) mg/dL to 13.1 (1.9) mg/dL (significance level p =0.000). At the EOP, 79.0% ( n =309/391) of patients had viral suppression. Conclusion. Care of adolescent HIV+ patients remains a challenge, but the implementation of specific projects involving adolescents and youth leaders can increase adherence and improve viral suppression

An assessment of option B implementation for the prevention of mother to child transmission in Dschang, Cameroon: results from the DREAM (Drug Resource Enhancement against AIDS and Malnutrition) cohort

Introduction: Scaling up of antiretroviral therapy (ART) to HIV+ pregnant women is crucial for the elimination of HIV infection in children. The aim of this study was to evaluate the feasibility and effectiveness of triple ART for Prevention of Mother-to Child Transmission (PMTCT) in Cameroon. Methods: HIV-positive pregnant women attending the DREAM Centre of Dschang, Cameroon for prenatal care were enrolled in a prospective cohort study, and received ART until the end of breastfeeding or indefinitely if their CD4 count was &lt;350mm3. Infants were evaluated for HIV infection at 1, 6 and 12 months of age. Results: A total of 298 women were enrolled. Among them, 152 were already on established ART. Women were followed until 6 months after delivery with a retention rate of 92.6%. Eight women died. Those with a CD4 count &lt;350 cells/mm3 during pregnancy had the highest mortality risk (RR 2.53; 95% CL= 1.86-3.44). The HIV  transmission rate was 1.2% at 12 months with an HIV free survival of 91%. In the proportional Cox regression analysis, the following factors were positively associated with infant mortality: maternal CD4&lt; 350 cells/mm3, no breastfeeding in the first 6 months of life, weight-for-age z score &lt; -2. Conclusion: Results confirm the feasibility and effectiveness of the implementation of Option B, with very low rates of HIV MTC  transmission, and potential benefits to the health of mothers and infants with earlier initiation of ART. Breastfeeding again demonstrates to be highly beneficial for the growth and survival of HIV exposed children.Pan African Medical Journal 2016; 2

Measurement of viral load by the automated Abbott real-time HIV-1 assay using dried blood spots collected and processed in Malawi and Mozambique

Background. The use of dried blood spots (DBS) for HIV-1 viral load quantification can greatly improve access to viral monitoring for HIV-infected patients receiving treatment in resource-limited settings.Objectives. To evaluate and validate HIV viral load measurement from DBS in sub-Saharan Africa, with a reliable, all-automated, standard commercial assay such as the Abbott m2000.Methods. A total of 277 DBS were collected in different health centres in Malawi and Mozambique and analysed for viral load determination using the Abbott m2000 assay with the corresponding plasma samples as gold standard. Samples were extracted using the m2000SP automatic extractor and then processed as the plasma samples using the specific 1.0 mL HIV-RNA DBS protocol.Results. Among samples with detectable HIV-RNA the correlation between viral load obtained from the paired 131 plasma and DBS samples was high (r=0.946). Overall, viral load values between DBS and plasma differed by less than 0.5 log unit in 90.1% of cases and by less than 1 log unit in 100% of cases. Using a threshold of 1 000 copies/mL (defining virological failure in resource-limited settings), sensitivity was 94.2% and specificity 98.6%, and both positive and negative predictive values were high (98.5% and 94.5%, respectively).Conclusion. DBS extracted and processed using the Abbott automated system can be reliably used in resource-limited setting to diagnose virological failure

Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data

BACKGROUND: Sputum is the most widely used sample to diagnose active tuberculosis, but many people living with HIV are unable to produce sputum. Urine, in contrast, is readily available. We hypothesised that sample availability influences the diagnostic yield of various tuberculosis tests. METHODS: In this systematic review and meta-analysis of individual participant data, we compared the diagnostic yield of point-of-care urine-based lipoarabinomannan tests with that of sputum-based nucleic acid amplification tests (NAATs) and sputum smear microscopy (SSM). We used microbiologically confirmed tuberculosis based on positive culture or NAAT from any body site as the denominator and accounted for sample provision. We searched PubMed, Web of Science, Embase, African Journals Online, and clinicaltrials.gov from database inception to Feb 24, 2022 for randomised controlled trials, cross-sectional studies, and cohort studies that assessed urine lipoarabinomannan point-of-care tests and sputum NAATs for active tuberculosis detection in participants irrespective of tuberculosis symptoms, HIV status, CD4 cell count, or study setting. We excluded studies in which recruitment was not consecutive, systematic, or random; provision of sputum or urine was an inclusion criterion; less than 30 participants were diagnosed with tuberculosis; early research assays without clearly defined cutoffs were tested; and humans were not studied. We extracted study-level data, and authors of eligible studies were invited to contribute deidentified individual participant data. The main outcomes were the tuberculosis diagnostic yields of urine lipoarabinomannan tests, sputum NAATs, and SSM. Diagnostic yields were predicted using Bayesian random-effects and mixed-effects meta-analyses. This study is registered with PROSPERO, CRD42021230337. FINDINGS: We identified 844 records, from which 20 datasets and 10 202 participants (4561 [45%] male participants and 5641 [55%] female participants) were included in the meta-analysis. All studies assessed sputum Xpert (MTB/RIF or Ultra, Cepheid, Sunnyvale, CA, USA) and urine Alere Determine TB LAM (AlereLAM, Abbott, Chicago, IL, USA) in people living with HIV aged 15 years or older. Nearly all (9957 [98%] of 10 202) participants provided urine, and 82% (8360 of 10 202) provided sputum within 2 days. In studies that enrolled unselected inpatients irrespective of tuberculosis symptoms, only 54% (1084 of 1993) of participants provided sputum, whereas 99% (1966 of 1993) provided urine. Diagnostic yield was 41% (95% credible interval [CrI] 15-66) for AlereLAM, 61% (95% Crl 25-88) for Xpert, and 32% (95% Crl 10-55) for SSM. Heterogeneity existed across studies in the diagnostic yield, influenced by CD4 cell count, tuberculosis symptoms, and clinical setting. In predefined subgroup analyses, all tests had higher yields in symptomatic participants, and AlereLAM yield was higher in those with low CD4 counts and inpatients. AlereLAM and Xpert yields were similar among inpatients in studies enrolling unselected participants who were not assessed for tuberculosis symptoms (51% vs 47%). AlereLAM and Xpert together had a yield of 71% in unselected inpatients, supporting the implementation of combined testing strategies. INTERPRETATION: AlereLAM, with its rapid turnaround time and simplicity, should be prioritised to inform tuberculosis therapy among inpatients who are HIV-positive, regardless of symptoms or CD4 cell count. The yield of sputum-based tuberculosis tests is undermined by people living with HIV who cannot produce sputum, whereas nearly all participants are able to provide urine. The strengths of this meta-analysis are its large size, the carefully harmonised denominator, and the use of Bayesian random-effects and mixed-effects models to predict yields; however, data were geographically restricted, clinically diagnosed tuberculosis was not considered in the denominator, and little information exists on strategies for obtaining sputum samples. FUNDING: FIND, the Global Alliance for Diagnostics