LESSONS FROM THE FIELD

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

La contribution du Malawi à l'initiative « trois millions d'ici 2005 » : résultats obtenus et défis à relever

La contribución de Malawi a la iniciativa «tres millones para 2005»: logros y retos

Edwin Libamba^I; Simon D Makombe^I; Anthony D Harries^I,1; Erik J Schouten^II; Joseph Kwong-Leung Yu^III; Olesi Pasulani^IV; Eustice Mhango^V; John Aberle-Grasse^VI; Mindy Hochgesang^VI; Eddie Limbambala^VII; Douglas Lungu^VIII

^IClinical HIV Unit, Ministry of Health, PO Box 30377, Lilongwe, Malawi
^IIHIV Coordinator, Ministry of Health, Lilongwe, Malawi
^IIITaiwan Medical Mission, Mzuzu Central Hospital, Mzuzu, Malawi
^IVMédecins sans Frontières Belgium, Thyolo District Hospital, Malawi
^VLighthouse Clinic, Lilongwe, Malawi
^VICentres for Disease Control, Lilongwe office, Malawi
^VIIWHO country office, Lilongwe, Malawi
^VIIIDepartment of Clinical Services, Ministry of Health, Lilongwe, Malawi

ABSTRACT

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.

RÉSUMÉ

PROBLÉMATIQUE: De nombreux pays pauvres en ressources ont entamé l'extension du traitement antirétroviral (ART). Si les informations provenant des différents établissements font état d'une mise en æuvre satisfaisante, les données restent limitées quant aux progrès accomplis par les services publics au niveau national.
DÉMARCHE: Le Malawi a commencé l'extension du traitement antirétroviral au niveau national en 2004 au moyen d'une approche structurée utilisant principalement une association fixe de type générique, associant stavudine, lamivudine et néviparine. Le traitement est fourni gratuitement aux sujets porteurs du VIH et remplissant les critères d'inclusion et un système normalisé est appliqué pour le recrutement des malades, le suivi mensuel, l'enregistrement et la surveillance, ainsi que pour la notification des cas et des issues du traitement. Une supervision et une évaluation trimestrielles sont assurées dans tous les centres de traitement.
SITUATION LOCALE: En janvier 2004, un traitement antirétroviral était fourni à quelque 4000 malades dans neuf centres relevant du secteur public. En décembre 2005, 60 de ces centres délivraient gratuitement des antirétroviraux à 37 840 malades par l'intermédiaire de systèmes nationaux normalisés. L'analyse des résultats trimestriels du traitement pour les cohortes a montré qu'au bout de 12 mois 80 % des sujets étaient en vie, 10 % étaient décédés, alors qu'on avait perdu la trace de 9 % d'entre eux et qu'on enregistrait 1 % d'abandons du traitement.
ENSEIGNEMENTS TIRÉS: Les résultats ont pu être obtenus grâce à des directives nationales claires sur le traitement antirétroviral, à la collaboration entre les partenaires chargés de la mise en æuvre, à une formation intensive des cliniciens et des infirmières, à un système structuré d'accréditation des centres appelés à délivrer le traitement, à une supervision et une surveillance trimestrielles, ainsi qu'à un approvisionnement continu en antirétroviraux. Les principaux défis consistent à améliorer le nombre - limité au demeurant - d'enfants, de femmes enceintes et de malades souffrant de la tuberculose et entamant un traitement ARV et à réduire la forte mortalité précoce et le nombre de sujets perdus de vue. L'aptitude du secteur de la santé à faire face au nombre sans cesse plus élevé de cas et à étendre les activités de prévention en plus du traitement est aussi une source de préoccupations. C'est la capacité à relever ces défis qui conditionnera le succès du traitement antirétroviral au Malawi.

RESUMEN

PROBLEMA: Muchos países con escasos recursos han iniciado una expansión del tratamiento antirretrovírico (TAR). Aunque los informes de algunas clínicas señalan el éxito de la iniciativa, hay escasa información sobre los progresos realizados en las instituciones gubernamentales a nivel nacional.
ESTRATEGIA: Malawi comenzó en 2004 la expansión nacional del TAR con una estrategia estructurada, centrada en el tratamiento con un genérico consistente en la combinación de estavudina, lamivudina y nevirapina a dosis fijas. El tratamiento es ofrecido gratuitamente a los pacientes infectados por VIH que cumplen los criterios, y hay un sistema normalizado de reclutamiento de los pacientes, seguimiento mensual, registro, y monitorización y notificación de los casos y los resultados. Todos los lugares donde se dispensa el tratamiento son supervisados y evaluados trimestralmente.
ENTORNO LOCAL: En enero de 2004 había nueve centros del sector público que proporcionaban TAR a unos 4 000 pacientes. En diciembre de 2005 había 60 centros del sector público que proporcionaban TAR gratuito a 37 840 pacientes en el marco de los sistemas nacionales normalizados. El análisis de los resultados trimestrales del tratamiento de las cohortes a los 12 meses reveló que el 80% de los pacientes estaban vivos y el 10% muertos, mientras que en el 9% se había interrumpido el seguimiento y en el 1% se había detenido el tratamiento.
ENSEÑANZAS: Los logros se debieron a la existencia de directrices nacionales claras sobre el TAR, al trabajo en colaboración con los asociados, a un plan intensivo de formación centrado en los ayudantes clínicos y las enfermeras, a un sistema estructurado de acreditación de los centros dispensadores de TAR, a la supervisión y monitorización trimestrales, y al hecho de que nunca se agotaran las existencias de antirretrovíricos. Los principales retos consisten en aumentar el número de niños, embarazadas y pacientes tuberculosos que reciben TAR, y evitar la elevada mortalidad inicial y las interrupciones del seguimiento. La capacidad del sector de la salud para hacer frente al aumento del número de casos y la ampliación de la prevención a la par del tratamiento serán determinantes del éxito futuro del TAR en Malawi.

Background

In December 2003, the World Health Organization (WHO) and the joint United Nations Programme on HIV and AIDS (UNAIDS) launched the "3
by 5" initiative, with the goal of having 3 million people on antiretroviral therapy (ART) in developing countries by the end of 2005. By December 2005, an estimated 1.3 million people from low- and middle-income countries had started treatment, with 810 000 of these living in sub-Saharan Africa.¹

Although the 3 by 5 target was not reached, it has been a remarkable effort, particularly in the challenging working arena of sub-Saharan Africa. Reports from clinics in Botswana,² Kenya,³ Uganda⁴ and other African countries⁵ have shown that ART can be delivered successfully to HIV-infected eligible patients with excellent clinical and immunological benefit. However, despite these encouraging successes, there is limited information about how ART delivery has fared in the routine government health services of resource-poor African countries.

In Malawi, we embarked on national scale-up of ART through government and mission health facilities in early 2004. With 170 000 HIV-infected patients thought to be in need of ART,⁶ the country set a target to have 80 000 patients on treatment by the end of 2005. This goal was in line with the WHO initiative to place half the patients in need of ART in developing countries on treatment by 2005. We have previously reported on progress made during 2004,⁷ and here we report on Malawi's achievements and the technical challenges faced during the "3 by 5" campaign up to December 2005.

Scale-up methods

Details of ART delivery in Malawi between 2004 and 2005 have been described elsewhere.⁸ A standardized structured approach was used for treatment, details of which are shown in Box 1.

With the shortage of doctors in Malawi, paramedical clinical officers and medical assistants and nurses were trained to manage and deliver ART. The HIV Unit of the Ministry of Health and selected partners developed a 5-day training module and a certification of competence linked to a formal examination, and successful participants then undertook a 2-week practical clinical attachment at one of the experienced ART sites. The HIV Unit and the same selected partners implemented the training by mid-2004. By the end of 2005, 1138 health care workers in the public sector including 118 doctors, 384 clinical officers, 23 medical assistants and 613 nurses had been trained and certified in ART management.

Sixty facilities in the public health sector were selected for ART scale-up between 2004 and 2005, with each site being accredited by the HIV Unit of the Ministry of Health before being allowed to deliver ART. At the beginning of 2004, nine public health facilities were delivering ART using their own systems and treatments. By July 2005 there were 60 facilities, all of which were delivering ART using national standardized systems.

Results

In early 2004, an estimated 4000 patients had started on ART in the public health sector. By the end of 2005, the number of patients cumulatively started on ART was 37 840, which was 47% of the national target. Characteristics and outcomes of patients started on ART are shown in Table 1. ART was given to 6680 patients with active or previous tuberculosis, who as a result were staged in WHO clinical stage III or stage IV (18% of those placed on ART), and 336 HIV-positive pregnant women through Prevention of Mother to Child Transmission programmes (1% of those placed on ART).

For reporting purposes, cohorts of patients are grouped by quarters of the calendar year, allowing 6-month and 12-month cohort outcome analyses to be performed. For example, all patients registered in a cohort from January to March 2005 could have their outcomes assessed on 30 September 2005, and these data were included in the 6-month outcome analysis (although we do recognize that this method includes patient outcomes 6–9 months after starting ART). This same cohort at a later time could also have their outcomes assessed on 31 March 2006, with these data being included in the 12-month outcome analysis.

During each of the supervisory and monitoring visits in 2005 and 2006, data from all cohorts of patients at the ART facilities were included in 6-month and 12-month outcome analyses: these were combined to give results which are shown in Fig.1. Outcomes at 6 months and 12 months were similar, indicating that most deaths in a young programme such as Malawi's occur in the early months of ART.

Discussion

Achievements

The Malawian example that we describe shows that using a simple, structured approach to ART delivery, government health sectors can deliver treatment to large numbers of patients fairly quickly with good outcomes. A few facilities in Malawi are supported by international organizations, such as Médecins sans Frontières, but in most facilities local health care workers are the sole providers of ART. Although the national target for numbers of people on ART was not reached, there has been general satisfaction to date with the achievement in ART scale-up, especially given that trained health care personnel, monitoring tools and systems of drug procurement and distribution were not in place at the beginning of 2004.

There have been several factors responsible for the successes in ART delivery in Malawi. The most important are: clear national ART guidelines, with an emphasis on the system of registration, monitoring and recording of results; agreement by all implementing partners to work with the Ministry of Health and use national standardized systems; an intensive training schedule focused on clinical officers and nurses learning the ART guidelines; a structured system of accrediting ART sites before they are permitted to deliver treatment to patients; quarterly supervision and monitoring of all ART delivery sites by the HIV Unit of the Ministry of Health and its partners; and an ART procurement and distribution system that was associated with no stock-outs of antiretroviral drugs. ART facilities vary in their quality and some do not perform as well as they should. However, regular and structured supervision ensures that a basic standard is always maintained and that data are always collected.

Challenges

There have been several challenges in the scaling-up of ART delivery. Children, HIV-positive pregnant women and patients with tuberculosis were, and still are, under-represented in treatment populations. The new revised 2006 WHO Paediatric Guidelines,⁹ and Malawi's revised ART Guidelines,¹⁰ which emphasize the importance of ART for children and recommend prioritizing CD4-lymphocyte counts in HIV-infected pregnant women, should increase the number of children and pregnant women accessing ART. Tuberculosis remains a difficult problem as a result of drug-drug interactions between rifampicin and non-nucleoside reverse transcriptase inhibitors¹¹ and the fact that in Malawi ART is usually distributed from hospital clinics, whereas delivery of anti-tuberculosis treatment is decentralized and is done from health centres.¹²

There is a high early death rate in patients starting ART, similar to that reported from other low-income countries.¹³ This finding is related to patients presenting with advanced HIV disease, tuberculosis, bacterial infections, malignancy and immune reconstitution syndrome.¹⁴ An aggressive approach to the diagnosis of tuberculosis before initiating ART and concomitant broad-spectrum antibiotic prophylaxis targeted at common serious bacterial infections may be two ways to reduce this problem of early deaths. The number of cases lost to follow-up is also of concern, and operational research is needed to identify the true outcomes of these patients to establish a more complete data set for analysis.

Other challenges to ART scale-up include equitable access to ART sites especially for patients in rural areas, the capacity of the health sector to absorb the extra demands of ART delivery without compromising other aspects of general health care, and the scaling-up of prevention efforts alongside treatment.¹⁵

Acknowledgements

AD Harries is supported by Family Health International, USA, and EJ Schouten is supported by Management Sciences for Health, USA.

Funding: The ART programme is supported by the Global Fund and WHO, but the study itself was not funded by this organizations.

Competing interests: none declared.

References

1. World Health Organization and UNAIDS. Progress on global access to HIV antiretroviral therapy. a report on "3 by 5" and beyond. Geneva: WHO; 2006.        

2. Wester CW, Kim S, Bussmann H, Avalos A, Ndwapi N, Peter TF, et al. Initial response to highly active antiretroviral therapy in HIV-1C-infected adults in a public sector treatment program in Botswana. J Acquir Immune Defic Syndr 2005;40:336-43.        

3. Wools-Kaloustian K, Kimaiyo S, Diero L, Siika A, Sidle J, Yiannoutsos CT, et al. Viability and effectiveness of large-scale HIV treatment initiatives in sub-Saharan Africa: experience from Western Kenya. AIDS 2006;20:41-8.        

4. Spacek LA, Shihab HM, Kamya MR, Mwesigire D, Ronald A, Mayanja H, et al. Response to antiretroviral therapy in HIV-infected patients attending a public, urban clinic in Kampala, Uganda. Clin Infect Dis 2006;42:252-9.        

5. Ivers LC, Kendrick D, Doucette K. Efficacy of antiretroviral therapy programs in resource-poor settings: a meta-analysis of the published literature. Clin Infect Dis 2005;41:217-24.        

6. National AIDS Commission. National estimates of HIV/AIDS in Malawi. Lilongwe, Malawi: National AIDS Commission; 2003.        

7. Libamba E, Makombe S, Mhango E, de Ascurra Teck O, Limbambala E, Schouten EJ, et al. Supervision, monitoring and evaluation of nationwide scale-up of antiretroviral therapy in Malawi. Bull World Health Organ 2006;84:320-6.        

8. Libamba E, Makombe S, Harries AD, Chimzizi R, Salaniponi FM, Schouten EJ, et al. Scaling up antiretroviral therapy in Africa: learning from tuberculosis control programmes; the case of Malawi. Int J Tuberc Lung Dis 2005;9:1062-71.        

9. World Health Organization. Antiretroviral therapy of HIV infection in infants and children in resource-limited settings, towards universal access: recommendations for a public health approach (2006 revision). Geneva: World Health Organization;2006.        

10. Malawian Ministry of Health. Treatment of AIDS: guidelines for the use of antiretroviral therapy in Malawi. Second edition. Lilongwe: Malawian Ministry of Health; 2006.        

11. Kwara A, Flanigan TP, Carter EJ. Highly active antiretroviral therapy (HAART) in adults with tuberculosis: current status. Int J Tuberc Lung Dis 2005;9:248-57.        

12. Zachariah R, Teck R, Ascurra O, Gomani P, Manzi M, Humblet P, et al. Can we get more HIV-positive tuberculosis patients on antiretroviral treatment in a rural district of Malawi? Int J Tuberc Lung Dis 2005;9:238-47.        

13. The Antiretroviral Therapy in Lower-Income Countries (ART-LINC) Collaboration and ART Cohort Collaboration (ART-CC) groups. Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries. Lancet 2006;367:817-24.        

14. Lawn SD, Myer L, Orrell C, Bekker L-G, Wood R. Early mortality among adults accessing a community-based antiretroviral service in South Africa: implications for programme design. AIDS 2005;19:2141-8.        

15. Van Damme W, Kober K, Laga M. The real challenges for scaling up ART in sub-Saharan Africa. AIDS 2006;20:653-6.        

(Submitted: 3 June 2006 – Final revised version received: 9 August 2006 – Accepted: 22 August 2006)

1 Correspondence to Dr Harries (email: adharries@malawi.net).