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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.

In 10 years, in line with the concept of universal access, 25 million HIV-infected patients in sub-Saharan Africa might be on antiretroviral therapy (ART). There are different models of ART delivery, from the individualised, medical approach to the simple, public health approach, both having distinct advantages and disadvantages. This mini-review highlights the essential components of both models and argues that, whatever the mix of different models in a country, both must be underpinned by similar core principles so that uninterrupted drug supplies, patient adherence to therapy and compliance with follow up are assured. Failure to do otherwise is to court disaster.

A national survey was carried out in all the 103 public sector and 38 private sector facilities in Malawi providing antiretroviral therapy (ART) to determine uptake of ART and subsequent treatment outcomes in police force personnel. All patients registered for ART and their subsequent treatment outcomes were censored on December 31st 2006. There were 85168 patients started on ART in both public and private sectors, of whom 463 (0.6%) were police force personnel. Of police force personnel starting ART, 17% were in WHO clinical stage 1 or 2 with a CD4-lymphocyte count of < or = 250 cells/microL and 83% were in stage 3 or 4. Treatment outcomes of police force personnel by the end of December 2006 were 302 (65%) alive and on ART at their registration facility, 59 (13%) dead, 30 (7%) lost to follow-up, 1 stopped treatment and 71 (15%) transferred to another facility. Their probability of being alive on ART at 6-, 12- and 18-months was 83.2%, 78.6% and 76.7% respectively. There has been a good access of police force personnel to ART since national scale up commenced with good treatment outcomes, and this should serve as an example for other police forces in the region.

Background: Malawi is making good progress scaling up antiretroviral therapy (ART), but we do not know the levels of access of high-risk, disadvantaged groups such as prisoners. The aim of this study was to measure access and treatment outcomes of prisoners on ART at the national level., Methodology: A retrospective cohort study was conducted examining patient follow-up records from all 103 public sector ART clinics in Malawi, and observations were censored on 31 December, 2006., Results: By 31 December, 2006, a total of 81,821 patients had been started on ART. Of these, 103 (0.13%) were prisoners. At ART initiation, 93% of prisoners were in World Health Organization (WHO) clinical stage 3 or 4 while 7% started in stage 1 or 2 with a CD4-lymphocyte count of < or =250/mm3. Treatment outcomes by the end of December 2006 were as follows: 66 (64%) alive and on ART at their registration facility; 9 (9%) dead; 8 (8%) lost to follow-up; and 20 (19%) transferred out to another facility. The probability of being alive and on ART at 6 and 12 months was 82.5% and 77.7%., Conclusions: In spite of the rapid scale-up of ART, only a small number of HIV-positive prisoners had accessed ART by the end of 2006. Treatment outcomes were good. Initiatives are now needed to improve access to HIV testing and ART in Malawi's prisons.

Background: Malawi is making good progress scaling up antiretroviral therapy (ART), but we do not know the levels of access of high-risk, disadvantaged groups such as prisoners. The aim of this study was to measure access and treatment outcomes of prisoners on ART at the national level., Methodology: A retrospective cohort study was conducted examining patient follow-up records from all 103 public sector ART clinics in Malawi, and observations were censored on December 31, 2006., Results: By December 31, 2006, a total of 81,821 patients had been started on ART. Of these, 103 (0.13%) were prisoners. At ART initiation, 93% of prisoners were in World Health Organization (WHO) clinical stage 3 or 4 while 7% started in stage 1 or 2 with a CD4-lymphocyte count of

Problem: In many resource-poor countries that are scaling up antiretroviral therapy (ART), 5-25% of patients are reported as "lost to follow-up". This figure is 9% in Malawi. There is no published information about the true outcome status of these patients., Approach: In four facilities in northern Malawi, ART registers and master cards were used to identify patients who had not attended the facility for 3 months or more and were thus registered as "lost to follow-up". Clinic staff attempted to trace these patients and ascertain their true outcome status., Local Setting: Of 253 patients identified as "lost to follow-up", 127 (50%) were dead, 58% of these having died within 3 months of their last clinic visit. Of the 58 patients (23%) found to be alive, 21 were still receiving ART and 37 had stopped treatment (high transport costs being the main reason for 13 patients). Sixty-eight patients (27%) could not be traced, most commonly because of an incorrect address in the register. Fewer patients were alive and more patients could not be traced from the central hospital compared with the peripheral hospitals., Relevant Changes: Better documentation of patients addresses and prompt follow-up of patients who are late for their appointments are required., Lessons Learned: ART clinics in resource-poor countries should ensure that patients addresses are correct and comprehensive. Clinics should also undertake contact tracing as soon as possible in the event of non-attendance, consider facilitating access to ART clinics and take loss to follow-up into consideration when assessing death rates.

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.

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.