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

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

Abstract 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

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

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

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

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