Prevention of mother-to-child transmission of HIV: a cross-sectional study in Malawi.

OBJECTIVE: To estimate the use and outcomes of the Malawian programme for the prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV). METHODS: In a cross-sectional analysis of 33 744 mother-infant pairs, we estimated the weighted proportions of mothers who had received antenatal HIV testing and/or maternal antiretroviral therapy and infants who had received nevirapine prophylaxis and/or HIV testing. We calculated the ratios of MTCT at 4-26 weeks postpartum for subgroups that had missed none or at least one of these four steps. FINDINGS: The estimated uptake of antenatal testing was 97.8%; while maternal antiretroviral therapy was 96.3%; infant prophylaxis was 92.3%; and infant HIV testing was 53.2%. Estimated ratios of MTCT were 4.7% overall and 7.7% for the pairs that had missed maternal antiretroviral therapy, 10.7% for missing both maternal antiretroviral therapy and infant prophylaxis and 11.4% for missing maternal antiretroviral therapy, infant prophylaxis and infant testing. Women younger than 19 years were more likely to have missed HIV testing (adjusted odds ratio, aOR: 4.9; 95% confidence interval, CI: 2.3-10.6) and infant prophylaxis (aOR: 6.9; 95% CI: 1.2-38.9) than older women. Women who had never started maternal antiretroviral therapy were more likely to have missed infant prophylaxis (aOR: 15.4; 95% CI: 7.2-32.9) and infant testing (aOR: 13.7; 95% CI: 4.2-83.3) than women who had. CONCLUSION: Most women used the Malawian programme for the prevention of MTCT. The risk of MTCT increased if any of the main steps in the programme were missed.

Characteristics and outcomes of women initiating ART during pregnancy versus breastfeeding in Option B+ in Malawi.

BACKGROUND: Malawi adopted the PMTCT strategy 'Option B+' in 2011, providing life-long ART for all HIV-infected pregnant and breastfeeding women. We explored differences in characteristics and outcomes of women initiating ART during pregnancy versus breastfeeding. METHODS: We conducted a retrospective cohort analysis of women in Zomba District, southern Malawi, from January 2012- September 2013. Data were extracted from the Zomba District Observational Cohort Study, a surveillance project collecting data from standardized Ministry of Health ART monitoring tools. RESULTS: 1986 (67.2 %) women initiated ART during pregnancy and 969 (32.8 %) during breastfeeding. Women initiating ART in breastfeeding were more likely to be > 30 years (aOR = 1.33, 95 % CI1.11-1.59, p = 0.003) and have WHO Stage 3/4 (aOR = 2.74, 95 % CI1.94-3.87, p < 0.001). Eighteen (0.6 %) deaths occurred and 942 (31.9 %) women defaulted ART. 'Early' death (< 30 days) occurred in 3 (0.1 %) women and 449 (16.4 %) women defaulted early. Death/default < 30 days was more likely among women initiating ART during pregnancy (aOR 1.62, 95 % CI1.28-2.05, p < 0.001) or < 30 years old (aOR 1.27, 95 % CI 1.02-1.57, p = 0.03) and was less likely among those with WHO Stage 3/4 (aOR 0.30, 95 % CI 0.15-0.60, p < 0.001). Using Kaplan-Meier estimators to investigate time to death/default, we showed a sharp drop in death/default-free survival probability at time zero, yet survival probability decreased in a nearly linear manner after this initial period of high default. Women under 30 years had increased rates of death/default over time (log rank test: p < 0.001), however no significant differences were observed in death/default over time associated with timing of ART initiation, documented clinical stage at initiation, health clinic size or adherence rates. CONCLUSIONS: Many women in Malawi started ART during breastfeeding within Option B+ and were older and had more advanced WHO Clinical Staging. This represents a missed PMTCT opportunity to initiate treatment early in pregnancy. Early defaulting is identified as a challenge within Option B+, and was more likely among younger women and those initiating ART in pregnancy. Targeted research to understand factors associated with uptake of ART during pregnancy and retention in care could improve the efficacy of Option B+ in Malawi.

Village registers for vital registration in rural Malawi.

Paper-based village registers were introduced 5 years ago in Malawi as a tool to measure vital statistics of births and deaths at the population level. However, usage, completeness and accuracy of their content have never been formally evaluated. In Traditional Authority Mwambo, Zomba district, Malawi, we assessed 280 of the 325 village registers with respect to (i) characteristics of village headmen who used village registers, (ii) use and content of village registers, and (iii) whether village registers provided accurate information on births and deaths. All village headpersons used registers. There were 185 (66%) registers that were regarded as 95% completed, and according to the registers, there were 115 840 people living in the villages in the catchment area. In 2011, there were 1753 births recorded in village registers, while 6397 births were recorded in health centre registers in the same catchment area. For the same year, 199 deaths were recorded in village registers, giving crude death rates per 100 000 population of 189 for males and 153 for females. These could not be compared with death rates in health centre registers due to poor and inconsistent recording in these registers, but they were compared with death rates obtained from the 2010 Malawi Demographic Health Survey that reported 880 and 840 per 100 000 for males and females, respectively. In conclusion, this study shows that village registers are a potential source for vital statistics. However, considerable inputs are needed to improve accuracy of births and deaths, and there are no functional systems for the collation and analysis of data at the traditional authority level. Innovative ways to address these challenges are discussed, including the use of solar-powered electronic village registers and mobile phones, connected with each other and the health facilities and the District Commissioner's office through the cellular network and wireless coverage.

Updating a patient-level ART database covering remote health facilities in Zomba district, Malawi: lessons learned.

SETTING: A non-governmental organization, Dignitas International, working in partnership with the Ministry of Health in Malawi, adopted innovative, low-technology methods to collect, capture, and manage patient-level antiretroviral therapy (ART) data in a district database covering 26 remote low-resource facilities in Zomba District, Malawi. OBJECTIVE: To establish a longitudinal, observational database of routinely collected program data that could serve as a program monitoring and evaluation tool as well as a platform to conduct effective operational research. DESIGN: This article describes the processes developed for digital capture of paper-based ART clinical records at health facilities and updating them in a central electronic database. It documents and focuses on lessons learned during the implementation and review of processes. CONCLUSIONS: Data quality can only be ensured with regular review of, and compliance with, clearly delineated workflow protocols and adequate staffing and supervision. Through the implementation of this procedure, we expect to improve data quality, completeness, and use of routine ART clinical data in low-resource settings.

Burden, characteristics, management and outcomes of HIV-infected patients with Kaposi's sarcoma in Zomba, Malawi.

SETTING: Antiretroviral treatment (ART) clinic at Zomba Central Hospital, Malawi. DESIGN: Retrospective analysis of records (2004-2011) of human immunodeficiency virus (HIV) infected patients with Kaposi's sarcoma (KS). OBJECTIVES: To determine the number and characteristics of HIV-infected adult patients with KS on ART and vincristine (VCR) therapy and their treatment outcomes. RESULTS: A total of 545 HIV-infected patients with KS (58% male, median age 33 years) were included in the study. The baseline median CD4 count was 180 cells/µl (interquartile range 111-287). Cumulative outcomes were as follows: 168 (31%) were still alive, 133 (24%) had died, 172 (32%) were lost to follow-up and 71 (13%) had transferred out; 229 had received at least one course of VCR, 171 had received less than one full course and 145 had not received VCR. The survival probability for 229 patients who received at least one course of VCR was 65% at 1 year, 42% at 2 years and 13% by 6 years. Patients who started VCR therapy before or concurrently with ART had a higher risk of death and generally a higher risk of death and loss to follow-up than those who started VCR after ART. CONCLUSION: Poor outcomes were noted in HIV-infected patients with KS in a programme setting in Malawi. Other treatment interventions, including combination and/or second-line chemotherapy and earlier ART initiation, are needed to reduce morbidity and mortality.

Evaluation of lay health workers' needs to effectively support anti-tuberculosis treatment adherence in Malawi.

OBJECTIVE: To identify barriers and facilitators to efforts by lay health workers (LHWs) to support anti-tuberculosis treatment adherence in Malawi to inform the design of a knowledge translation intervention for improving adherence. DESIGN: Qualitative study utilizing focus groups and interviews conducted with LHWs providing tuberculosis (TB) care in Zomba District, Malawi. RESULTS: Participants identified lack of knowledge, both general (understanding of TB and its treatment) and job-specific (understanding of tasks such as completion of treatment forms), as the key barrier to LHWs in their role as adherence supporters. Lack of knowledge among LHWs providing TB care was reported to lead to a lack of confidence, conflicting messages given to patients, poor interactions with patients and errors in documentation. In addition to lack of knowledge, a number of system barriers were identified as limiting LHWs' ability to function optimally, including a lack of physical resources, workload, communication delays and ineffective guardians. CONCLUSION: Our findings suggest a gap between LHW knowledge and their responsibilities as adherence supporters. The results have informed the development of an educational outreach intervention and point-of-care tool, to be evaluated in a randomized trial in Zomba District.

Reasons for accepting or refusing HIV services among tuberculosis patients at a TB-HIV integration clinic in Malawi.

SETTING: In Malawi, human immunodeficiency virus (HIV) prevalence among newly registered tuberculosis (TB) patients is 60-70%. In 2008, an integrated TBHIV clinic was established at a central hospital in Zomba. Despite the integration of TB-HIV activities and improved HIV service uptake, unacceptably high proportions of HIV-positive TB patients are still not receiving antiretroviral therapy (ART). OBJECTIVE: To identify factors that motivate or discourage TB patients from accepting HIV services. DESIGN: Retrospective analysis of patients registered for TB treatment (not yet on ART) between April 2008 and March 2009; qualitative interviews of 99 patients on TB treatment. RESULTS: Of 1773 newly registered TB patients who were not already on ART at the time of TB registration, 86% accepted HIV testing and counselling. Among HIV-positive TB patients, 38% started ART during or after anti-tuberculosis treatment. Young adults aged 15- 24 years were least likely to initiate ART. Motivation for accepting ART during TB treatment included prospects of regaining good health and longer life, and counselling by health care providers. Barriers to ART uptake included not being offered ART, high CD4 count, drug stockouts and fear of drug toxicities/interactions. CONCLUSION: Several factors that undermine uptake of ART have been highlighted; targeted measures urgently need to be addressed by TB-HIV programmes to overcome these barriers.

Diagnostic management and outcomes of pulmonary tuberculosis suspects admitted to a central hospital in Malawi.

SETTING: Zomba Central Hospital, Malawi. OBJECTIVE: To determine diagnostic management and outcomes of pulmonary tuberculosis (PTB) suspects admitted to adult wards. DESIGN: A retrospective, cross-sectional review of medical records of patients admitted to hospital between July and September 2010. RESULTS: There were 141 PTB suspects. Sputum examination was requested and performed in 67 (48%) suspects, but none were smear-positive. Chest X-ray (CXR) was requested and performed in 26 (39%) suspects whose sputum smears were negative. Eleven suspects had a CXR suggestive of PTB: two were started on TB treatment and eight died before treatment started. Human immunodeficiency virus (HIV) status was known for 50 patients (35% of all suspects) on admission, all of whom were HIV-positive. HIV testing was requested for 37 patients, but was only performed in 12, five of whom were HIV-positive. Only one patient was referred for antiretroviral treatment. There were 41 (29%) deaths, eight of whom had probable TB and were not treated. In the remaining 33 patients who died, only nine (27%) had sputum smears examined and four (12%) had a CXR. CONCLUSION: The study shows inadequacies in the diagnostic management of PTB suspects in the Zomba Central Hospital, but suggests opportunities for improvement.

Timing and uptake of ART during treatment for active tuberculosis in HIV co-infected adults in Malawi.

SETTING: Uptake of antiretroviral therapy (ART) in patients co-infected with tuberculosis (TB) and the human immunodeficiency virus (HIV) has historically been low in Malawi. In response, the National TB Programme piloted the initiation of ART 2 weeks after initiation of TB treatment in 2008-2009, a change from the prior policy of 2 months. OBJECTIVE: To determine at programme level if earlier initiation of ART in co-infected patients receiving TB treatment will increase the uptake and continuation of ART. DESIGN: A prospective observational pilot programme evaluation using routinely collected monitoring data from the first two sites with integrated TB-HIV services in Malawi. RESULTS: There was wide variability in the ART start time before and after the policy change. Before the policy change, 16% of patients initiated ART by 3 months compared to 24% after the policy change (P < 0.001). The proportion of all co-infected patients on ART increased from 32% before the policy change to 39% after (P < 0.001). Earlier initiation of ART did not increase the occurrence of side effects and did not reduce adherence to TB treatment. CONCLUSION: Earlier initiation of ART in co-infected patients receiving TB treatment improved the uptake and continuation of ART. Malawi ART guidelines in 2011 were changed from initiating ART after 2 months to as soon as possible after starting anti-tuberculosis treatment.

Micronutrient supplements and mortality of HIV-infected adults with pulmonary TB: a controlled clinical trial.

SETTING: Zomba and Blantyre, Malawi, Africa. OBJECTIVES: To determine whether daily micronutrient supplementation reduces the mortality of human immunodeficiency virus (HIV) infected adults with pulmonary tuberculosis (TB). DESIGN: A randomised, controlled clinical trial of micronutrient supplementation for HIV-positive and HIV-negative adults with pulmonary TB. Participants were enrolled at the commencement of chemotherapy for sputum smear-positive pulmonary TB and followed up for 24 months. RESULTS: A total of 829 HIV-positive and 573 HIV-negative adults were enrolled. During follow-up, 328 HIV-positive and 17 HIV-negative participants died. The proportion of HIV-positive participants who died in the micronutrient and placebo groups was 38.7% and 40.4%, respectively (P = 0.49). Micronutrient supplementation did not reduce mortality (hazard ratio [HR] 0.93, 95%CI 0.75-1.15) among HIV-positive adults. CONCLUSIONS: Micronutrient supplementation at the doses used in this study does not reduce mortality in HIV-positive adults with pulmonary TB in Malawi.

Low plasma selenium concentrations, high plasma human immunodeficiency virus load and high interleukin-6 concentrations are risk factors associated with anemia in adults presenting with pulmonary tuberculosis in Zomba district, Malawi.

BACKGROUND: Although anemia is common among adults with pulmonary tuberculosis and human immunodeficiency virus (HIV) infection in sub-Saharan Africa, the factors contributing to its pathogenesis have not been well characterized. OBJECTIVE: To characterize the antioxidant micronutrient status, interleukin-6 (IL-6) concentrations, and HIV load in relationship with anemia in adults with pulmonary tuberculosis. SETTING: Zomba district, Malawi. METHODS: Erythropoietin, IL-6, plasma HIV load, and markers of micronutrient status (hemoglobin (Hb), plasma concentrations of retinol, alpha-tocopherol, carotenoids, ferritin, zinc, and selenium) were measured in 500 adults who presented with pulmonary tuberculosis in Zomba Central Hospital, Malawi. RESULTS: Among 370 HIV-positive and 130 HIV-negative adults, the prevalence of anemia was 88 and 77%, respectively (P = 0.002), and moderate to severe anemia (Hb < 80 g/l) occurred in 30 and 15%, respectively (P = 0.001). Geometric mean IL-6 concentration was 21.1 pg/ml, with no difference between HIV-positive and -negative adults. The erythropoietin response to anemia was not different between adults with elevated IL-6 and those with lower IL-6 concentrations. In a multivariate logistic regression model, HIV load, and lower plasma selenium concentrations were associated with moderate to severe anemia. In a final multivariate linear regression model, IL-6, plasma HIV load, and plasma selenium concentrations were associated with Hb concentrations. CONCLUSION: This study suggests that low selenium concentrations, high HIV load, and high IL-6 concentrations are associated with anemia in adults with pulmonary tuberculosis in sub-Saharan Africa.

Malnutrition and the severity of lung disease in adults with pulmonary tuberculosis in Malawi.

SETTING: Zomba Central Hospital, Zomba, Malawi. OBJECTIVE: To examine the relationship between malnutrition and the severity of lung disease in human immunodeficiency virus (HIV) positive and negative adults with pulmonary tuberculosis (PTB). DESIGN: Cross-sectional study. METHODS: Chest radiographs and anthropometric measurements were obtained and bioelectrical impedance analysis was conducted in sputum-positive patients with pulmonary tuberculosis. Lung disease in chest radiographs was graded as normal, minimal, moderately advanced and far advanced according to a conventional classification system. RESULTS: Among 319 adults with PTB with or without HIV co-infection, body mass index (BMI), fat mass and phase angle were independently associated with increasing severity of lung disease. Multiple logistic regression analyses showed that BMI, fat mass and phase angle were associated with increasing severity of lung disease among 236 HIV-positive adults, when adjusted for sex, age, and plasma HIV load. CONCLUSION: The severity of lung disease in adults with PTB is associated with the extent of malnutrition, as reflected by BMI and body composition studies using bioelectrical impedance analysis.