Scaling-up antiretroviral therapy in Malawi.

Introduction Malawi is a low-income country with an estimated population of 16 million in 2012. (1) In 2004, approximately 930 000 Malawians were thought to be infected with human immunodeficiency virus (HIV), with an estimated 100 000 new HIV infections occurring annually and around 170000 people in immediate need of antiretroviral therapy (ART). (2) That year, the Malawian Ministry of Health decided to scale up ART nationwide. Before the scale-up, only nine hospitals in the public sector were delivering ART to about 3000 patients and treatment was unstructured, few health-care workers had received formal training in ART and there were no national systems of monitoring, recording and reporting. (3) This paper discusses the achievements of the scale-up in the face of severe health-system constraints and highlights the lessons learnt and new challenges. Public health approach The health ministry assumed responsibility for the national scale-up of ART, adhering strongly to the principle of equitable access to therapy for everyone in Malawi, regardless of geographical location or type of health facility in the area. The implementing partners and stakeholders, including the private sector, worked together with the HIV department of the health ministry to develop national scale-up plans and implement one standardized system to deliver and monitor ART. An effective system was already in place for diagnosing HIV infection. Criteria were developed for starting ART, based on the World Health Organization's (WHO) clinical stage 3 and 4 disease, or a CD4+ T-lymphocyte count below 200 cells/ pL. ART was to be delivered free of charge at all levels of the health service from central hospitals to local health centres, and the same methods were to be used for assessing patients for ART eligibility, initiating treatment, following-up patients, and monitoring, recording and reporting on treatment outcomes. Plans for the initial and continued scale-up had clearly stated objectives and activities, with associated milestones and timelines, which provided a benchmark to assess implementation. (4) The objectives included providing long-term ART, monitoring treatment outcomes on a quarterly basis, ensuring patients took at least 95% of their scheduled drugs, and having 50% of patients alive and on ART at three years from starting therapy. The activities included setting up the government HIV department, ensuring HIV testing, organizing procurement and distribution of drugs, and implementing supervision. From the start, the Global Fund to Fight AIDS, Tuberculosis and Malaria financially supported the scale-up and remained the main funder. While having only one funding source meant less funding overall, it made it easier for the country to develop and implement a uniform approach that best fitted the country's resources and infrastructure. An intensive and innovative training schedule took place in the early months of 2004, focused on clinical officers and nurses learning the ART guidelines. The courses were country-wide, run by the HIV department and its partners, and focused on teaching health-care workers the ART guidelines, including how to monitor and do cohort reporting. All participants had to pass an examination with marks of at least 85%. Trained health workers were given checklists of activities to be undertaken when they returned to their facilities and were mandated to brief facility staff, the local government district headquarters and neighbouring health centres about ART. The HIV department carried out a formal structured accreditation of each ART facility before allowing health workers to start administering treatment. The accreditation included checking all the staff had been briefed, ensuring guidelines were in place, inspecting ART clinics and checking pharmacy security. The trainings were and continue to be done once for new sites, with shorter trainings repeated when new guidelines are developed' and new treatment strategies are implemented and standardized. …