Institutional maternal and perinatal deaths: a review of 40 low and middle income countries.

BACKGROUND: Understanding the magnitude and clinical causes of maternal and perinatal mortality are basic requirements for positive change. Facility-based information offers a contextualized resource for clinical and organizational quality improvement. We describe the magnitude of institutional maternal mortality, causes of death and cause-specific case fatality rates, as well as stillbirth and pre-discharge neonatal death rates. METHODS: This paper draws on secondary data from 40 low and middle income countries that conducted emergency obstetric and newborn care assessments over the last 10 years. We reviewed 6.5 million deliveries, surveyed in 15,411 facilities. Most of the data were extracted from reports and aggregated with excel. RESULTS: Hemorrhage and hypertensive diseases contributed to about one third of institutional maternal deaths and indirect causes contributed another third (given the overrepresentation of sub-Saharan African countries with large proportions of indirect causes). The most lethal obstetric complication, across all regions, was ruptured uterus, followed by sepsis in Latin America and the Caribbean and sub-Saharan Africa. Stillbirth rates exceeded pre-discharge neonatal death rates in nearly all countries, possibly because women and their newborns were discharged soon after birth. CONCLUSIONS: To a large extent, facility-based findings mirror what population-based systematic reviews have also documented. As coverage of a skilled attendant at birth increases, proportionally more deaths will occur in facilities, making improvements in record-keeping and health management information systems, especially for stillbirths and early neonatal deaths, all the more critical.

Scaling-up antiretroviral therapy in Malawi.

PROBLEM: In Malawi, health-system constraints meant that only a fraction of people infected with human immunodeficiency virus (HIV) and in immediate need of antiretroviral treatment (ART) received treatment. APPROACH: In 2004, the Malawian Ministry of Health launched plans to scale-up ART nationwide, adhering to the principle of equity to ensure fair geographical access to therapy. A public health approach was used with standardized training and treatment and regular supervision and monitoring of the programme. LOCAL SETTING: Before the scale-up, an estimated 930 000 people in Malawi were HIV-infected, with 170 000 in immediate need of ART. About 3000 patients were on ART in nine clinics. RELEVANT CHANGES: By December 2015, cumulatively 872 567 patients had been started on ART from 716 clinics, following national treatment protocols and using the standard monitoring system. LESSONS LEARNT: Strong national leadership allowed the ministry of health to implement a uniform system for scaling-up ART and provided benchmarks for implementation on the ground. New systems of training staff and accrediting health facilities enabled task-sharing and decentralization to peripheral health centres and a standardized approach to starting and monitoring ART. A system of quarterly supervision and monitoring, into which operational research was embedded, ensured stocks of drug supplies at facilities and adherence to national treatment guidelines.

Act local, think global: how the Malawi experience of scaling up antiretroviral treatment has informed global policy.

The scale-up of antiretroviral therapy (ART) in Malawi was based on a public health approach adapted to its resource-poor setting, with principles and practices borrowed from the successful tuberculosis control framework. From 2004 to 2015, the number of new patients started on ART increased from about 3000 to over 820,000. Despite being a small country, Malawi has made a significant contribution to the 15 million people globally on ART and has also contributed policy and service delivery innovations that have supported international guidelines and scale up in other countries. The first set of global guidelines for scaling up ART released by the World Health Organization (WHO) in 2002 focused on providing clinical guidance. In Malawi, the ART guidelines adopted from the outset a more operational and programmatic approach with recommendations on health systems and services that were needed to deliver HIV treatment to affected populations. Seven years after the start of national scale-up, Malawi launched a new strategy offering all HIV-infected pregnant women lifelong ART regardless of the CD4-cell count, named Option B+. This strategy was subsequently incorporated into a WHO programmatic guide in 2012 and WHO ART guidelines in 2013, and has since then been adopted by the majority of countries worldwide. In conclusion, the Malawi experience of ART scale-up has become a blueprint for a public health response to HIV and has informed international efforts to end the AIDS epidemic by 2030.

How operational research influenced the scale up of antiretroviral therapy in Malawi.

The national scale up of antiretroviral therapy in Malawi is based on a public health approach, with principles and practices borrowed from the successful World Health Organization "DOTS" tuberculosis control framework. The scale up of antiretroviral therapy was under-pinned by a very strong monitoring and evaluation system, which was used to audit the scale up approach and conduct operational research to answer relevant questions. Examples of research included:- i) access to antiretroviral therapy, populations and social groups served, and how the different groups fared with regard to outcomes; ii) determining whether the quality of data at antiretroviral therapy sites was adequate and whether external supervision was needed; iii) finding feasible ways of reducing the high early mortality in patients starting treatment in both Malawi and the sub-Saharan African region; iv) the causes of loss-to-follow-up, what happened to patients who transferred out of sites and whether transfer-out patients had outcomes comparable to those who did not transfer; and v) the important question of whether antiretroviral therapy scale up reduced population mortality. The answers to these questions had an important influence on how treatment was delivered in the country, and show the value of this work within a programme setting. Key generic lessons include the importance of i) research questions being relevant to programme needs, ii) studies being coordinated, designed and undertaken within a programme, iii) study findings being disseminated at national stakeholder meetings and through publications in peer-reviewed journals and iv) research being used to influence policy and practice, improve programme performance and ultimately patient treatment outcomes.

Why did the scale-up of HIV treatment work? A case example from Malawi.

The national scale-up of antiretroviral therapy (ART) in Malawi is based on a public health approach, with principles and practices borrowed from the successful DOTS (directly observed treatment short course-the system used to successfully deliver antituberculosis treatment to people in some of the poorest countries of the world) tuberculosis control framework. During the first 6 years, the number of patients registered on treatment increased from 3000 to >350,000 in both the public and private sectors. The most important reasons for this success have been strong international and national leadership combined with adequate funds, a standardized approach to ART with practical guidelines, an approved national scale-up plan with clear, time-bound milestones; investment in an intensive program of training and accreditation of ART sites, quarterly supervision and monitoring of ART and operational research, rational drug forecasting and no stock-outs of drugs during the first few years, and involvement of the private sector. The looming challenges of human resources, guaranteed financial support, better but also more expensive ART regimens, use of electronic medical records to monitor response to therapy, and attention to HIV prevention need to be met head-on and solved if the momentum of the earlier years is to be maintained.

A public health approach to rapid scale-up of antiretroviral treatment in Malawi during 2004-2006.

BACKGROUND: Approximately 1 million people are infected with HIV in Malawi, where AIDS is the leading cause of death in adults. By December 31, 2007, more than 141,000 patients were initiated on antiretroviral treatment (ART) by use of a public health approach to scale up HIV services. METHODS: We analyzed national quarterly and longitudinal cohort data from October 2004 to December 2006 to examine trends in characteristics of patients initiating ART, end-of-quarter clinical outcomes, and 6- and 12-month survival probability. FINDINGS: During a 27-month period, 72,666 patients were initiated on ART, of whom about two-thirds were women. The percentage of patients initiated on ART who were children and farmers increased from 5.5% to 9.0% and 23% to 32%, respectively (P < 0.001 for trends). Estimated survival probability ranged from 85% to 88% at 6 months and 81% to 84% at 12 months on ART. INTERPRETATION: In Malawi, a public health approach to ART increased treatment access and maintained high 6- and 12-month survival. Resource-limited countries scaling up ART programs may benefit from this approach of simplified clinical decision making, standardized ART regimens, nonphysician care, limited laboratory support, and centralized monitoring and evaluation.

Outcomes of patients with Kaposi's sarcoma who start antiretroviral therapy under routine programme conditions in Malawi.

AIDS-associated Kaposi's sarcoma (KS) is the most common AIDS-related malignancy in sub-Saharan Africa, with a generally unfavourable prognosis. We report on six-month and 12-month cohort treatment outcomes of human immunodeficiency virus (HIV)-positive KS patients and HIV-positive non-KS patients treated with antiretroviral therapy (ART) in public sector facilities in Malawi. Data were collected from standardized antiretroviral (ARV) patient master cards and ARV patient registers. Between July and September 2005, 7905 patients started ART-488 (6%) with a diagnosis of KS and 7417 with a non-KS diagnosis. Between January and March 2005, 4580 patients started ART-326 (7%) with a diagnosis of KS and 4254 with a non-KS diagnosis. At six-months and 12-months, significantly fewer KS patients were alive and significantly more had died or defaulted compared to non-KS patients. HIV-positive KS patients on ART in Malawi have worse outcomes than other patients on ART. Methods designed to improve these outcomes must be found.

Lower early mortality rates among patients receiving antiretroviral treatment at clinics offering cotrimoxazole prophylaxis in Malawi.

OBJECTIVE: To determine whether Malawi antiretroviral treatment (ART) clinics providing cotrimoxazole (CTX) prophylaxis had lower early mortality rates compared with clinics not providing CTX. METHODS: Retrospective cohort study of eleven ART clinics in Malawi that were or were not providing CTX. Medical record abstraction was performed for all patients (N = 1295) initiating ART between July 1 and December 15, 2005. At 5 ART sites, CTX was given to patients dosed at 960 mg daily or 480 mg twice a day (according to national guidelines). RESULTS: When all defaults (patients lost to follow-up for >90 days) were excluded from the analysis, the 6-month mortality rate was 10.7% in patients receiving ART at CTX clinics compared with 18.0% in those not at CTX clinics (6-month mortality risk reduction = 40.7%; P = 0.0013). Kaplan-Meier survival curves for patients receiving CTX and patients not receiving CTX were significantly different; survival differences were apparent as early as 40 to 45 days after initiation of ART. CONCLUSIONS: Patients receiving ART in Malawi at clinics offering CTX prophylaxis had significantly reduced mortality during the first 6 months of ART. This additional intervention may have the potential to improve the lives of patients on ART, because CTX is readily available and relatively inexpensive and can, in principle, be easily introduced into ART delivery programs.

Assessment of a national monitoring and evaluation system for rapid expansion of antiretroviral treatment in Malawi.

OBJECTIVES: Monitoring and evaluation of national antiretroviral therapy (ART) programs is vital, but routine, standardized assessment of national ART patient monitoring systems has not been established. Malawi has undertaken an ambitious ART scale-up effort, with over 57,000 patients initiated on ART by June 2006. We assessed the national ART monitoring and evaluation system in Malawi to ensure that the response to the epidemic was being monitored efficiently and effectively, and that data collected were useful. METHODS: The evaluation, performed in August 2005, generally followed the Updated Guidelines for Evaluating Public Health Surveillance Systems (CDC) and Interim Patient Monitoring Guidelines for HIV Care and ART (WHO). Assessment was conducted with qualitative methods, including twelve ART site visits, with standardized key informant interviews with ART clinic coordinators, clinical staff, and data managers, at each site. Meetings were also held with key governmental stakeholders, including Ministry of Health and National AIDS Commission. RESULTS: The national monitoring and evaluation system devised by the Ministry of Health HIV/AIDS Unit is successful in achieving its objectives, and facilitates important aspects of the national response to HIV. Several basic changes in the data collection tools and system would facilitate more effective long-term assessment of the ART program and support improved patient care. As the number of ART sites and patients continues to expand, the current manual paper-based system may be overwhelmed. Identification and implementation of a feasible electronic data system that would maintain and improve data quality and the efficiency of data recording and reporting and enhance patient care is a priority. CONCLUSIONS: The assessment of ART monitoring and evaluation systems can optimize the effectiveness of national ART programs, and should be considered in other resource-constrained countries rapidly scaling up ART.

Ensuring uninterrupted supplies of antiretroviral drugs in resource-poor settings: an example from Malawi.

PROBLEM: Drug procurement and distribution practices are weak in many resource-poor countries, and are a major reason for lack of access to medicines. With many countries scaling up antiretroviral therapy (ART), it is vital to avoid interrupted drug supplies, which would lead to drug resistance and treatment failure. APPROACH: Malawi has adapted a model, based on that adopted by the country's Tuberculosis Control Programme, to allow rational ART drug forecasting. LOCAL SETTING: The model includes a focus on one standardized first-line ART regimen; a "push system" and "ceilings" for first-line ART drugs for facilities; use of starter pack and continuation pack kits; quarterly monitoring of patient outcomes and ART drug stocks at facility level; provision of a three-month buffer stock of ART drugs at facility level; and use of a procurement and distribution system outside central medical stores. LESSONS LEARNED: The focus on a single first-line regimen, "ceilings" for first-line ART drugs and quarterly data collections to calculate drug needs (for new and follow-up patients, respectively), as well as the use of an independent procurement facility, allow drug orders to be made 6-9 months ahead. These measures have so far ensured that there have been no ART drug stock-outs in the country.

Malawi's contribution to "3 by 5": achievements and challenges.

PROBLEM: Many resource-poor countries have started scaling up antiretroviral therapy (ART). While reports from individual clinics point to successful implementation, there is limited information about progress in government institutions at a national level. APPROACH: Malawi started national ART scale-up in 2004 using a structured approach. There is a focus on one generic, fixed-dose combination treatment with stavudine, lamivudine and nevirapine. Treatment is delivered free of charge to eligible patients with HIV and there is a standardized system for recruiting patients, monthly follow-up, registration, monitoring and reporting of cases and outcomes. All treatment sites receive quarterly supervision and evaluation. LOCAL SETTING: In January 2004, there were nine public sector facilities delivering ART to an estimated 4 000 patients. By December 2005, there were 60 public sector facilities providing free ART to 37,840 patients using national standardized systems. Analysis of quarterly cohort treatment outcomes at 12 months showed 80% of patients were alive, 10% dead, 9% lost to follow-up and 1% had stopped treatment. LESSONS LEARNED: Achievements were the result of clear national ART guidelines, implementing partners working together, an intensive training schedule focused on clinical officers and nurses, a structured system of accrediting facilities for ART delivery, quarterly supervision and monitoring, and no stock-outs of antiretroviral drugs. The main challenges are to increase the numbers of children, pregnant women and patients with tuberculosis being started on ART, and to avert high early mortality and losses to follow-up. The capacity of the health sector to cope with escalating case loads and to scale up prevention alongside treatment will determine the future success of ART delivery in Malawi.

Supervision, monitoring and evaluation of nationwide scale-up of antiretroviral therapy in Malawi.

OBJECTIVE: To describe the supervision, monitoring and evaluation strategies used to assess the delivery of antiretroviral therapy during nationwide scale-up of treatment in Malawi. METHODS: In the first quarter of 2005, the HIV Unit of the Ministry of Health and its partners (the Lighthouse Clinic; Médecins Sans Frontières-Belgium, Thyolo district; and WHO's Country Office) undertook structured supervision and monitoring of all public sector health facilities in Malawi delivering antiretroviral therapy. FINDINGS: Data monitoring showed that by the end of 2004, there were 13,183 patients (5274 (40%) male, 12 527 (95%) adults) who had ever started antiretroviral therapy. Of patients who had ever started, 82% (10 761/13,183) were alive and taking antiretrovirals; 8% (1026/13,183) were dead; 8% (1039/13,183) had been lost to follow up; <1% (106/13,183) had stopped treatment; and 2% (251/13,183) had transferred to another facility. Of those alive and on antiretrovirals, 98% (7098/7258) were ambulatory; 85% (6174/7258) were fit to work; 10% (456/4687) had significant side effects; and, based on pill counts, 96% (6824/7114) had taken their treatment correctly. Mistakes in the registration and monitoring of patients were identified and corrected. Drug stocks were checked, and one potential drug stock-out was averted. As a result of the supervisory visits, by the end of March 2005 recruitment of patients to facilities scheduled to start delivering antiretroviral therapy had increased. CONCLUSION: This report demonstrates the importance of early supervision for sites that are starting to deliver antiretroviral therapy, and it shows the value of combining data collection with supervision. Making regular supervisory and monitoring visits to delivery sites are essential for tracking the national scale-up of delivery of antiretrovirals.

Who is accessing antiretroviral therapy during national scale-up in Malawi?

Malawi is scaling-up provision of free antiretroviral therapy (ART) in the public sector. In the fourth quarter of 2004 and the first quarter of 2005, 3261 and 4530 new patients, respectively, were started on ART. Of these patients, approximately 40% were male and 95% were adults aged > or =13 years. The age group data show that women who accessed ART were in general 10 years younger than men. Between 84% and 90% of patients were started on ART because of being clinically assessed as being in WHO stages III or IV, with the remainder started on ART owing to a low CD4 lymphocyte count. The number of tuberculosis (TB) patients started on ART was 351 (11% of ART patients) in the fourth quarter of 2004 and 702 (15% of ART patients, and 16% of registered TB patients) in the first quarter of 2005. Twenty-nine pregnant women were referred to ART from prevention of mother-to-child transmission programmes in the first quarter of 2005. Between 56% and 62% of patients were subsistence farmers, housewives or in business. Steady progress is being made with national scale-up, although more attention needs to be directed to children, pregnant women and patients with TB to improve their access to ART.

Monitoring the response to antiretroviral therapy in resource-poor settings: the Malawi model.

With assistance from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Malawi is scaling-up the delivery of antiretroviral (ARV) therapy to HIV-positive eligible patients. The country has developed National ARV Treatment Guidelines, which emphasize a structured and standardized approach for all aspects of ARV delivery, including monitoring and evaluation. Using the successful DOTS model adapted by National TB Control Programmes throughout the world, Malawi has developed a system of quarterly ARV cohort and cumulative ARV quarterly analyses. Thyolo district, in the southern region of Malawi, has been using this system since April 2003. This paper describes the standardized ARV treatment regimens and the treatment outcomes used in Thyolo to assess the impact of treatment, the registration and monitoring systems and how the cohort analyses are carried out. Data are presented for case registration and treatment outcome for the first quarterly cohort (April to June) and the combined cohorts (April to June and July to September). Such quarterly analyses may be useful for districts and Ministries of Health in assessing ARV delivery, although the burden of work involved in calculating the numbers may become large once ARV delivery systems have been established for several years.