Scaling-up health information systems to improve HIV treatment: An assessment of initial patient monitoring systems in Mozambique.

INTRODUCTION: The rapid scale-up of HIV care and treatment in resource-limited countries requires concurrent, rapid development of health information systems to support quality service delivery. Mozambique, a country with an 11.5% prevalence of HIV, has developed nation-wide patient monitoring systems (PMS) with standardized reporting tools, utilized by all HIV treatment providers in paper or electronic form. Evaluation of the initial implementation of PMS can inform and strengthen future development as the country moves towards a harmonized, sustainable health information system. OBJECTIVE: This assessment was conducted in order to 1) characterize data collection and reporting processes and PMS resources available and 2) provide evidence-based recommendations for harmonization and sustainability of PMS. METHODS: This baseline assessment of PMS was conducted with eight non-governmental organizations that supported the Ministry of Health to provide 90% of HIV care and treatment in Mozambique. The study team conducted structured and semi-structured surveys at 18 health facilities located in all 11 provinces. Seventy-nine staff were interviewed. Deductive a priori analytic categories guided analysis. RESULTS: Health facilities have implemented paper and electronic monitoring systems with varying success. Where in use, robust electronic PMS facilitate facility-level reporting of required indicators; improve ability to identify patients lost to follow-up; and support facility and patient management. Challenges to implementation of monitoring systems include a lack of national guidelines and norms for patient level HIS, variable system implementation and functionality, and limited human and infrastructure resources to maximize system functionality and information use. CONCLUSIONS: This initial assessment supports the need for national guidelines to harmonize, expand, and strengthen HIV-related health information systems. Recommendations may benefit other countries with similar epidemiologic and resource-constrained environments seeking to improve PMS implementation.

Beyond indicators: advances in global HIV monitoring and evaluation during the PEPFAR era.

Monitoring and evaluation (M&E) is fundamental to global HIV program implementation and has been a cornerstone of the President's Emergency Plan for AIDS Relief (PEPFAR). Rapid results were crucial to demonstrating feasibility and scalability of HIV care and treatment services early in PEPFAR. When national HIV M&E systems were nascent, the rapid influx of funds and the emergency expansion of HIV services contributed to the development of uncoordinated "parallel" information systems to serve donor demands for information. Close collaboration of PEPFAR with multilateral and national partners improved harmonization of indicators, standards, methods, tools, and reports. Concurrent PEPFAR investments in surveillance, surveys, program monitoring, health information systems, and human capacity development began to show signs of progress toward sustainable country-owned systems. Awareness of the need for and usefulness of data increased, far beyond discussions of indicators and reporting. Emphasis has turned toward ensuring the quality of data and using available data to improve the quality of care. Assessing progress toward an AIDS-free generation requires that the global community can measure the reduction of new HIV infections in children and adults and monitor the coverage, quality, and outcomes of highly efficacious interventions in combination. Building national M&E systems requires sustained efforts over long periods of time with effective leadership and coordination. PEPFAR, in close collaboration with its global and national partners, is well positioned to transform the successes and challenges associated with early rapid scale-up into future opportunities for sustainable, cost-effective, country-owned programs and systems.

Outcomes and associated risk factors of patients traced after being lost to follow-up from antiretroviral treatment in Lilongwe, Malawi.

BACKGROUND: Loss to follow-up is a major challenge of antiretroviral treatment (ART) programs in sub-Saharan Africa. Our objective was to a) determine true outcomes of patients lost to follow-up (LTFU) and b) identify risk factors associated with successful tracing and deaths of patients LTFU from ART in a large public sector clinic in Lilongwe, Malawi. METHODS: Patients who were more than 2 weeks late according to their last ART supply and who provided a phone number or address in Lilongwe were eligible for tracing. Their outcomes were updated and risk factors for successful tracing and death were examined. RESULTS: Of 1800 patients LTFU with consent for tracing, 724 (40%) were eligible and tracing was successful in 534 (74%): 285 (53%) were found to be alive and on ART; 32 (6%) had stopped ART; and 217 (41%) had died. Having a phone contact doubled tracing success (adjusted odds ratio, aOR = 2.1, 95% CI 1.4-3.0) and odds of identifying deaths [aOR = 1.8 (1.2-2.7)] in patients successfully traced. Mortality was higher when ART was fee-based at initiation (aOR = 2.3, 95% CI 1.1-4.7) and declined with follow-up time on ART. Limiting the analysis to patients living in Lilongwe did not change the main findings. CONCLUSION: Ascertainment of contact information is a prerequisite for tracing, which can reveal outcomes of a large proportion of patients LTFU. Having a phone contact number is critical for successful tracing, but further research should focus on understanding whether phone tracing is associated with any differential reporting of mortality or LTFU.

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.

Early warning indicators for HIV drug resistance in Malawi.

BACKGROUND: Malawi started rapid scale-up of antiretroviral therapy (ART) in 2004 and by December 2006 had initiated over 85,000 patients on treatment. Early warning indicator (EWI) reports can help to minimize the risk of emerging drug resistance. METHODS: Data collected during the routine quarterly supervision of 103 public sector sites was used to compile the first EWI report for HIV drug resistance (HIVDR) in Malawi, reflecting outcomes for October to December 2006. RESULTS: All sites reach the World Health Organization (WHO) targets for prescribing practices and drug supply continuity. The target for adherence was achieved by 85% of sites and 84% achieved the target for minimizing treatment defaults; however, less than half of all sites reach the WHO target for patient retention. CONCLUSIONS: These results emphasize the importance of defaulter tracing and initiating treatment earlier in the course of HIV infection. As part of a comprehensive HIVDR monitoring programme, the Ministry of Health plans for on-going tracking of these indicators, as well as special data collection from the private sector. Plans are also underway to gather information on other recommended indicators that are not collected during routine supervision.

Assessing the quality of data aggregated by antiretroviral treatment clinics in Malawi.

PROBLEM: As national antiretroviral treatment (ART) programmes scale-up, it is essential that information is complete, timely and accurate for site monitoring and national planning. The accuracy and completeness of reports independently compiled by ART facilities, however, is often not known. APPROACH: This study assessed the quality of quarterly aggregate summary data for April to June 2006 compiled and reported by ART facilities ("site report") as compared to the "gold standard" facility summary data compiled independently by the Ministry of Health supervision team ("supervision report"). Completeness and accuracy of key case registration and outcome variables were compared. Data were considered inaccurate if variables from the site reports were missing or differed by more than 5% from the supervision reports. Additionally, we compared the national summaries obtained from the two data sources. LOCAL SETTING: Monitoring and evaluation of Malawi's national ART programme is based on WHO's recommended tools for ART monitoring. It includes one master card for each ART patient and one patient register at each ART facility. Each quarter, sites complete cumulative cohort analyses and teams from the Ministry of Health conduct supervisory visits to all public sector ART sites to ensure the quality of reported data. RELEVANT CHANGES: Most sites had complete case registration and outcome data; however many sites did not report accurate data for several critical data fields, including reason for starting, outcome and regimen. The national summary using the site reports resulted in a 12% undercount in the national total number of persons on first-line treatment. Several facility-level characteristics were associated with data quality. LESSONS LEARNED: While many sites are able to generate complete data summaries, the accuracy of facility reports is not yet adequate for national monitoring. The Ministry of Health and its partners should continue to identify and support interventions such as supportive supervision to build sites' capacity to maintain and compile quality data to ensure that accurate information is available for site monitoring and national planning.

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.

A national survey of the impact of rapid scale-up of antiretroviral therapy on health-care workers in Malawi: effects on human resources and survival.

OBJECTIVE: To assess the human resources impact of Malawis rapidly growing antiretroviral therapy (ART) programme and balance this against the survival benefit of health-care workers who have accessed ART themselves. METHODS: We conducted a national cross-sectional survey of the human resource allocation in all public-sector health facilities providing ART in mid-2006. We also undertook a survival analysis of health-care workers who had accessed ART in public and private facilities by 30 June 2006, using data from the national ART monitoring and evaluation system. FINDINGS: By 30 June 2006, 59 581 patients had accessed ART from 95 public and 28 private facilities. The public sites provided ART services on 2.4 days per week on average, requiring 7% of the clinician workforce, 3% of the nursing workforce and 24% of the ward clerk workforce available at the facilities. We identified 1024 health-care workers in the national ART-patient cohort (2% of all ART patients). The probabilities for survival on ART at 6 months, 12 months and 18 months were 85%, 81% and 78%, respectively. An estimated 250 health-care workers lives were saved 12 months after ART initiation. Their combined work-time of more than 1000 staff-days per week was equivalent to the human resources required to provide ART at the national level. CONCLUSION: A large number of ART patients in Malawi are managed by a small proportion of the health-care workforce. Many health-care workers have accessed ART with good treatment outcomes. Currently, staffing required for ART balances against health-care workers lives saved through treatment, although this may change in the future.

A national survey of teachers on antiretroviral therapy in Malawi: access, retention in therapy and survival.

BACKGROUND: HIV/AIDS is having a devastating effect on the education sector in sub-Saharan Africa. A national survey was conducted in all public sector and private sector facilities in Malawi providing antiretroviral therapy (ART) to determine the uptake of ART by teachers and their outcomes while on treatment. METHODOLOGY/PRINCIPAL FINDINGS: A retrospective cohort study was carried out based on patient follow-up records from ART Registers and treatment master cards in all 138 ART clinics in Malawi; observations were censored on September 30(th) 2006. By this date, Malawi's 102 public sector and 36 private sector ART clinics had registered a total of 72,328 patients for treatment. Of these, 2,643 (3.7%) were teachers. Adjusting for double-registration caused by clinic transfers, it is estimated that 2,380 individual teachers had ever accessed ART. There were 15% of teachers starting ART in WHO clinical stage 1 or 2 with a CD4-lymphocyte count of

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.

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.

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.