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.

Increased mortality of male adults with AIDS related to poor compliance to antiretroviral therapy in Malawi.

OBJECTIVE: To investigate the effect of gender on mortality of HIV-infected adults receiving antiretroviral therapy (ART) and its possible reasons. METHODS: A retrospective study to review the records for outcomes of adult cases receiving ART at Mzuzu Central Hospital, Malawi, between July 2004 and December 2006. RESULTS: Over the study period, 2838 adult AIDS patients received ART. Of these, 2029 (71.5%) were alive and still on ART, 376 (13.2%) were dead and 433 (15.3%) were lost to follow-up. Survival analysis with Kaplan-Meier estimator showed significantly higher survival rates among females than males in WHO stage 1, 2 and 3 (both P < 0.0001) and borderline in stage 4 (P = 0.076). The Cox model revealed a death hazard ratio (males vs. females) of 1.70 (95% confidence interval 1.35-2.15) after controlling for WHO clinical stages, body mass index and age. More men than women were lost to follow-up in all occupations except health workers. CONCLUSIONS: The most important reasons for a higher mortality in male patients starting ART may relate to their seeking medical care at a more advanced stage of immunodeficiency and poorer compliance with therapy. The issue needs to be addressed in scaling up ART programmes in Africa.

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 prisoners on antiretroviral therapy in Malawi: access to treatment and outcomes on therapy.

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.

Risk factors for early mortality in children on adult fixed-dose combination antiretroviral treatment in a central hospital in Malawi.

OBJECTIVES: In children aged less than 15 years, to determine the cumulative proportion of deaths occurring within 3 and 6 months of starting split-tablet adult fixed-dose combination antiretroviral therapy (ART) and to identify risk factors associated with early deaths. DESIGN: A retrospective cohort analysis. METHODS: Data were collected and analysed from ART patient master cards and the ART register of all children registered for treatment between July 2004 and September 2006 in the ART clinic at Mzuzu Central Hospital, northern Malawi. RESULTS: A total of 439 children started on ART, of whom 220 (50%) were male; 37 (8%) were aged less than 18 months, 172 (39%) 18 months to 5 years, and 230 (52%) were 6-14 years. By September 2006, 49 children (11%) had died, of whom 35 (71%) died by 3 months and 44 (89%) by 6 months. The cumulative incidence of death at 3, 6, 12 and 24 months after ART was 8, 12, 13 and 15%, respectively. After multivariate analysis, being in World Health Organization clinical stage 4, having severe wasting and severe immunodeficiency were factors significantly associated with 3-month mortality and 6-month mortality, respectively. CONCLUSION: Although children do well on ART, there is high early mortality. Scaling up HIV testing and simple diagnostic tests for infants and children, expanding routine provision of cotrimoxazole prophylaxis, and investigating the role of nutritional interventions are three measures that, if implemented and expanded countrywide, may improve ART outcomes.

High-resolution CT for identify patients with smear-positive, active pulmonary tuberculosis.

PURPOSE: This study evaluates the use of high-resolution computed tomography (HRCT) to differentiate smear-positive, active pulmonary tuberculosis (PTB) from other pulmonary infections in the emergency room (ER) setting. METHODS: One hundred and eighty-three patients diagnosed with pulmonary infections in an ER were divided into an acid fast bacillus (AFB) smear-positive, active PTB group (G1=84) and a non-AFB smear-positive, pulmonary infection group (G2=99). HRCT images from a 64-Multidetector CT were analyzed, retrospectively, for the morphology, number, and segmental distribution of pulmonary lesions. RESULTS: Utilizing multivariate analysis, five variables were found to be independent risk factors predictive of G1: (1) consolidation involving the apex segment of right upper lobe, posterior segment of the right upper lobe, or apico-posterior segment of the left upper lobe; (2) consolidation involving the superior segment of the right or left lower lobe; (3) presence of a cavitary lesion; (4) presence of clusters of nodules; (5) absence of centrilobular nodules. A G1 prediction score was generated based on these 5 criteria to help differentiate G1 from G2. The area under the receiver operating characteristic (ROC) curve was 0.96 ± 0.012 in our prediction model. With an ideal cut-off point score of 3, the specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) are 90.9%, 96.4%, 90.0% and 96.8%, respectively. CONCLUSION: The use of this AFB smear-positive, active PTB prediction model based on 5 key HRCT findings may help ER physicians determine whether or not isolation is required while awaiting serial sputum smear results in high risk patients.

The effectiveness of continuing training for traditional birth attendants on their reproductive health-care knowledge and performance.

OBJECTIVE: to evaluate the effectiveness of continuing training for traditional birth attendants (TBAs) on their reproductive knowledge and performance. SETTING: Mzuzu Central Hospital in the northern region of Malawi. PARTICIPANTS AND ANALYSIS: a total of 81 TBAs trained during 2004 and 2006 in Mzuzu, Malawi received continuing training courses. Their reproductive knowledge was assessed by a structured questionnaire during 2004 and 2007. A multivariate generalised estimating equation (GEE) model was constructed to determine the associations between their reproductive knowledge scores and age, years of education, time since the last training course, test frequency and number of babies delivered. FINDINGS: from July 2004 to June 2007, a total of 1984 pregnant women visited these trained TBAs. A total of 79 (4.0%) mothers were referred to health facilities before the birth due to first-born or difficult pregnancies. No maternal deaths occurred among the remaining mothers. There were 26 deaths among 1905 newborn babies, giving a perinatal mortality rate of 13.6 per 1000 live births. The GEE model demonstrated that knowledge scores of TBAs were significantly higher for TBAs under the age of 45 years, TBAs with more than five years of education, TBAs who had taken a training course within one year, and TBAs with a higher test frequency. CONCLUSION AND IMPLICATIONS FOR PRACTICE: continuing training courses are effective to maintain the reproductive knowledge and performance of trained TBAs. It is recommended that continuing training should be offered regularly, at least annually.

Applying the global positioning system and google earth to evaluate the accessibility of birth services for pregnant women in northern Malawi.

INTRODUCTION: The objective of this study was to validate the combined use of the Global Positioning System (GPS) and Google Earth for measuring the accessibility of health care facilities for pregnant women in northern Malawi. METHODS: We used GPS and Google Earth to identify 5 major health care facilities in Mzuzu (Malawi) and the homes of 79 traditional birth attendants (TBAs). The distance and time required for each TBA to reach the nearest health care facility were measured by both GPS and by self-report of the TBAs. A convenience sample of 1138 pregnant women was interviewed about their choices of birth sites for current and previous pregnancies and the time and cost required to access health care facilities. RESULTS: The correlation coefficient between the objective measurements by GPS and subjective reports by TBAs for time required from their homes to health care facilities was 0.654 (P < .001). Among pregnant women, 45.6% reported that they could reach a health care facility within 2 hours; 23.8% reported paying more than $1 for transportation to health care facilities. For the current study, 82.6% of women intended to give birth at a health care facility. However, only 48.7% of women actually gave birth in a health care facility in a previous pregnancy, and 32.6% were assisted by TBAs. DISCUSSION: Combined GPS and Google Earth can be useful in the evaluation of accessibility of health care facilities, especially for emergency obstetric care.

Antiretroviral therapy in the Malawi defence force: access, treatment outcomes and impact on mortality.

BACKGROUND: HIV/AIDS affects all sectors of the population and the defence forces are not exempt. A national survey was conducted in all public and private sectors in Malawi that provide antiretroviral therapy (ART) to determine the uptake of ART by army personnel, their outcomes while on treatment, and the impact of ART on mortality in the Malawi Defence Force. METHODOLOGY/PRINCIPAL FINDINGS: A retrospective cohort analysis was carried out, collecting data on access and retention on treatment from all 103 public and 38 private sector ART clinics in Malawi, using standardised patient master cards and clinic registers. Observations were censored on December 31(st) 2006. Independent data on mortality trends in army personnel from all causes between 2002 and 2006 were available from army records. By December 31(st) 2006, there were 85,168 patients ever started on ART in both public and private sectors, of whom 547 (0.7%) were army personnel. Of these, 22% started ART in WHO clinical stage 1 or 2 with a CD4-lymphocyte count of

Antiretroviral therapy in the Malawi police force: access to therapy and treatment outcomes.

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.

What happens to patients on antiretroviral therapy who transfer out to another facility?

BACKGROUND: Long term retention of patients on antiretroviral therapy (ART) in Africa's rapidly expanding programmes is said to be 60% at 2 years. Many reports from African ART programmes make little mention of patients who are transferred out to another facility, yet Malawi's national figures show a transfer out of 9%. There is no published information about what happens to patients who transfer-out, but this is important because if they transfer-in and stay alive in these other facilities then national retention figures will be better than previously reported. METHODOLOGY/PRINCIPAL FINDINGS: Of all patients started on ART over a three year period in Mzuzu Central Hospital, North Region, Malawi, those who transferred out were identified from the ART register and master cards. Clinic staff attempted to trace these patients to determine whether they had transferred in to a new ART facility and their outcome status. There were 805 patients (19% of the total cohort) who transferred out, of whom 737 (92%) were traced as having transferred in to a new ART facility, with a median time of 1.3 months between transferring-out and transferring-in. Survival probability was superior and deaths were lower in the transfer-out patients compared with those who did not transfer. CONCLUSION/SIGNIFICANCE: In Mzuzu Central Hospital, patients who transfer-out constitute a large proportion of patients not retained on ART at their original clinic of registration. Good documentation of transfer-outs and transfer-ins are needed to keep track of national outcomes. Furthermore, the current practice of regarding transfer-outs as being double counted in national cohorts and subtracting this number from the total national registrations to get the number of new patients started on ART is correct.

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.

True outcomes for patients on antiretroviral therapy who are "lost to follow-up" in Malawi.

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.

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 prisoners on antiretroviral therapy in Malawi: access to treatment and outcomes on therapy.

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