Acceptability and effectiveness of the storekeeper-based TB referral system for TB suspects in sub-districts of Lilongwe in Malawi.

BACKGROUND: Early access to tuberculosis diagnosis and treatment remains a challenge in developing countries. General use of informal providers such as storekeepers is common. The aim of this study was to determine the effectiveness and acceptability of a storekeeper-based referral system for TB suspects in urban settings of Lilongwe, Malawi. METHODS: The referral system intervention was implemented in two sub-districts. This was evaluated using a pre and post comparison as well as comparison with a third sub-district designated as the control. The intervention included training of storekeepers to detect and refer clients with chronic cough using predesigned referral letters along with monitoring and supervision. Data from a community based chronic cough survey and an audit of health centre records were used to measure its effectiveness. Focus group discussions and in-depth interviews were carried out to document acceptability of the intervention with the different stakeholders. RESULTS: Following the intervention, the mean patient delay appeared lower in the intervention than comparison areas (2.14 weeks (SD 5.8) vs 8.8 weeks (SD 15.1)). However, after adjusting for confounding variables this difference was not significant (p = 0.07). After the intervention the proportion of the population diagnosed with smear positive TB in the intervention sites (1.2 per 1000) was significantly higher than in the comparison area (0.6 per 1000, p<0.01) even after adjusting for sex and age. Qualitative findings suggested that (a) the referral letters triggered health workers to ask patients to submit sputum for TB diagnosis (b) the approach may be sustainable as the referral role was linked to the livelihood of the storekeepers. CONCLUSION: The study suggests that the referral system with storekeepers is sustainable and effective in increasing smear positive TB case notification. Studies that assess this approach for control of other diseases along with collection of specimens by storekeepers or similar providers are needed.

Operational research in Malawi: making a difference with cotrimoxazole preventive therapy in patients with tuberculosis and HIV.

BACKGROUND: In Malawi, high case fatality rates in patients with tuberculosis, who were also co-infected with HIV, and high early death rates in people living with HIV during the initiation of antiretroviral treatment (ART) adversely impacted on treatment outcomes for the national tuberculosis and ART programmes respectively. This article i) discusses the operational research that was conducted in the country on cotrimoxazole preventive therapy, ii) outlines the steps that were taken to translate these findings into national policy and practice, iii) shows how the implementation of cotrimoxazole preventive therapy for both TB patients and HIV-infected patients starting ART was associated with reduced death rates, and iv) highlights lessons that can be learnt for other settings and interventions. DISCUSSION: District and facility-based operational research was undertaken between 1999 and 2005 to assess the effectiveness of cotrimoxazole preventive therapy in reducing death rates in TB patients and subsequently in patients starting ART under routine programme conditions. Studies demonstrated significant reductions in case fatality in HIV-infected TB patients receiving cotrimoxazole and in HIV-infected patients about to start ART. Following the completion of research, the findings were rapidly disseminated nationally at stakeholder meetings convened by the Ministry of Health and internationally through conferences and peer-reviewed scientific publications. The Ministry of Health made policy changes based on the available evidence, following which there was countrywide distribution of the updated policy and guidelines. Policy was rapidly moved to practice with the development of monitoring tools, drug procurement and training packages. National programme performance improved which showed a significant decrease in case fatality rates in TB patients as well as a reduction in early death in people with HIV starting ART. SUMMARY: Key lessons for moving this research endeavour through to policy and practice were the importance of placing operational research within the programme, defining relevant questions, obtaining "buy-in" from national programme staff at the beginning of projects and having key actors or "policy entrepreneurs" to push forward the policy-making process. Ultimately, any change in policy and practice has to benefit patients, and the ultimate judge of success is whether treatment outcomes improve or not.

Evidence for changes in behaviour leading to reductions in HIV prevalence in urban Malawi.

BACKGROUND: At the epicentre of the HIV epidemic in Eastern Africa, HIV prevalence has appeared to stabilise in most countries. However, there are indications that the HIV epidemic in Malawi has recently declined. METHODS: We analysed sexual behaviour survey data from Malawi between 2000 and 2004 and HIV prevalence data from the national antenatal clinic HIV surveillance system between 1994 and 2007 using a mathematical modelling technique that can identify associations between behaviour change and reductions in incidence. RESULTS: In Malawi between 2000 and 2004 there were significant reductions in the proportion of 15-19 year olds starting sex, the proportion of men having sex with more than one woman in the previous year and significant increases in condom use by men with multiple partners. In the same period, prevalence dropped from 26% to 15% in urban areas among pregnant women and reduced by 40% among women aged 15-24 years. In the same period, prevalence remained at ∼12% in rural areas. Mathematical modelling suggests that the declines in prevalence in urban areas were associated with the behaviour changes and that, if the changes are maintained, this will have cumulatively averted 140,000 (95% interval: 65,000 to 160,000) HIV infections by 2010. CONCLUSION: Changes in sexual behaviour can avert thousands of new HIV infections in mature generalised hyper-endemic settings. In urban Malawi, the reduction in the number of men with multiple partners is likely to have driven the reduction in incidence. Understanding the causes of this change is a priority so that successful programmes and campaigns can be rapidly expanded to rural areas and other countries in the region.

New policies, new technologies: modelling the potential for improved smear microscopy services in Malawi.

BACKGROUND: To quantify the likely impact of recent WHO policy recommendations regarding smear microscopy and the introduction of appropriate low-cost fluorescence microscopy on a) case detection and b) laboratory workload. METHODOLOGY/PRINCIPAL FINDINGS: An audit of the laboratory register in an urban hospital, Lilongwe, Malawi, and the application of a simple modelling framework. The adoption of the new definition of a smear-positive case could directly increase case detection by up to 28%. Examining Ziehl-Neelsen (ZN) sputum smears for up to 10 minutes before declaring them negative has previously been shown to increase case detection (over and above that gained by the adoption of the new case definition) by 70% compared with examination times in routine practice. Three times the number of staff would be required to adequately examine the current workload of smears using ZN microscopy. Through implementing new policy recommendations and LED-based fluorescence microscopy the current laboratory staff complement could investigate the same number of patients, examining auramine-stained smears to an extent that is equivalent to a 10 minutes ZN smear examination. CONCLUSIONS/SIGNIFICANCE: Combined implementation of the new WHO recommendations on smear microscopy and LED-based fluorescence microscopy could result in substantial increases in smear positive case-detection using existing human resources and minimal additional equipment.

Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe.

OBJECTIVE: To assess the relative costs of accessing a TB diagnosis for the poor and for women in urban Lilongwe, Malawi, a setting where public health services are accessible within 6 kilometers and provided free of charge. METHODS: Patient and household direct and opportunity costs were assessed from a survey of 179 TB patients, systematically sampled from all public and mission health facilities in Lilongwe. Poverty status was determined from the 1998 Malawi Integrated Household Survey (MIHS). FINDINGS: On average, patients spent US$ 13 (MK 996 or 18 days' income) and lost 22 days from work while accessing a TB diagnosis. For non-poor patients, the total costs amounted to 129% of total monthly income, or 184% after food expenditures. For the poor, this cost rose to 248% of monthly income or 574% after food. When a woman or when the poor are sick, the opportunity costs faced by their households are greater. CONCLUSION: Patient and household costs of TB diagnosis are prohibitively high even where services are provided free of charge. In scaling up TB services to reach the Millennium Development Goals, there is an urgent need to identify strategies for diagnosing TB that are cost-effective for the poor and their households.

The use of a monitoring tool to assess counselling and HIV testing in the public health sector in Malawi.

Scaling up of counselling and HIV testing (VCT) services requires a system of regular monitoring and evaluation. AVCT monitoring tool was developed through a consultative process and used to assess counselling and HIV testing services in 16 government and mission hospitals in Malawi, which had started expanded HIV-TB activities in July 2003. The essential components of theVCT monitoring tool included assessments of: (i) the hospital VCT personnel, in particular the number of counsellors (full-time and part-time) and those trained in and performing whole blood rapid HIV testing; (ii) the hospital laboratory service, in particular the protocols for HIV testing; (iii) the number, structure and function of dedicated VCT rooms; (iv) registers for patients, clients and donors having HIV tests; and (v) the quality of VCT through structured interviews with HIV-positive patients with TB. The main findings were: 9644 patients and clients were HIV tested between July and September 2003; HIV testing protocols were not standardized and differed between hospitals; there was little in the way of external quality assurance and there were deficiencies in the counselling process. In each hospital, the mean time taken to obtain the data and complete theVCT monitoring tool was 3 h. TheVCT monitoring tool is straightforward to use, and the data collected should help to improve standardization, quality and future planning of VCT services in the country.

Management and outcome of TB suspects admitted to the medical wards of a central hospital in Malawi.

In a study conducted in the medical wards of Lilongwe Central Hospital, Malawi, 84 (18%) of 470 medical admissions were TB suspects. Of these, 21 (25%) had the diagnosis confirmed; the median length of time between admission and starting anti-TB treatment was 10 days. Of the remaining TB suspects, 24 (29%) had another diagnosis made, principally pneumonia, and 39 (46%) had no diagnosis made, with half of these patients dying under investigation in hospital. Improved and more rapid ways of managing TB suspects need to be found.

Monitoring the response to antiretroviral therapy in resource-poor settings: the Malawi model.

With assistance from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Malawi is scaling-up the delivery of antiretroviral (ARV) therapy to HIV-positive eligible patients. The country has developed National ARV Treatment Guidelines, which emphasize a structured and standardized approach for all aspects of ARV delivery, including monitoring and evaluation. Using the successful DOTS model adapted by National TB Control Programmes throughout the world, Malawi has developed a system of quarterly ARV cohort and cumulative ARV quarterly analyses. Thyolo district, in the southern region of Malawi, has been using this system since April 2003. This paper describes the standardized ARV treatment regimens and the treatment outcomes used in Thyolo to assess the impact of treatment, the registration and monitoring systems and how the cohort analyses are carried out. Data are presented for case registration and treatment outcome for the first quarterly cohort (April to June) and the combined cohorts (April to June and July to September). Such quarterly analyses may be useful for districts and Ministries of Health in assessing ARV delivery, although the burden of work involved in calculating the numbers may become large once ARV delivery systems have been established for several years.

The missing cases of tuberculosis in Malawi: the contribution from cross-border registrations.

Low case detection rates of new smear-positive pulmonary tuberculosis (PTB) patients globally are a cause for concern. The aim of this study was to determine for patients registered for TB in Malawi the number and percentage who lived in a neighbouring country and the registration, recording and reporting practices for these 'foreign' patients. All 44 non-private hospitals, which register and treat all TB patients in the public health sector in Malawi, were visited. Ten (23%) hospitals in 2001 and 14 (32%) in 2002 maintained a separate register for cross-border TB cases. Patients recorded in these registers were not formally reported to the Malawi National TB Programme (NTP), the neighbouring country's NTP, nor to WHO. They therefore constitute missing cases. In Malawi, the number of cross-border new smear-positive PTB cases was 77 in 2001 and 91 in 2002, constituting about 3% of missing smear-positive cases in those hospitals that maintain cross-border registers and about 1% of missing cases nationally.

Voluntary counselling, HIV testing and adjunctive cotrimoxazole reduces mortality in tuberculosis patients in Thyolo, Malawi.

OBJECTIVES: To assess the feasibility and effectiveness of voluntary counselling, HIV testing and adjunctive cotrimoxazole in reducing mortality in a cohort of tuberculosis (TB) patients registered under routine programme conditions in a rural district of Malawi. DESIGN: 'Before' and 'after' cohort study using historical controls. METHODS: Between 1 July 1999 and 30 June 2000 all TB patients were started on standardized anti-TB treatment, and offered voluntary counselling and HIV testing (VCT). Those found to be HIV-positive were offered cotrimoxazole at a dose of 480 mg twice daily, provided there were no contraindications. Side-effects were monitored clinically. End-of-treatment outcomes in this cohort (intervention group) were compared with a cohort registered between 1 July 1998 and 30 June 1999 in whom VCT and cotrimoxazole was not offered (control group). FINDINGS: A total of 1986 patients was registered in the study: 1061 in the intervention group and 925 in the control cohort. In the intervention group, 1019 (96%) patients were counselled pre-test, 964 (91%) underwent HIV testing and 938 (88%) were counselled post-test. The overall HIV-seroprevalence rate was 77%. A total of 693 patients were given cotrimoxazole of whom 14 (2%) manifested minor dermatological reactions. The adjusted relative risk of death in the intervention group compared with the control group was 0.81 (P < 0.001). The number needed to treat with VCT and adjunctive cotrimoxazole to prevent one death during anti-TB treatment was 12.5. INTERPRETATION: This study shows that VCT and adjunctive cotrimoxazole is feasible, safe and reduces mortality rates in TB patients under routine programme conditions.

The diagnosis of extrapulmonary tuberculosis in Malawi.

There is little information on a country-wide basis in sub-Saharan Africa about how the diagnosis of extra-pulmonary tuberculosis (EPTB) is made. A country-wide cross-sectional study was carried out in 40 non-private hospitals in Malawi which register and treat (TB) patients in order to assess diagnostic practices in adults registered with EPTB. All patients aged 15 years and above in hospital on treatment for EPTB were reviewed usingTB registers, case note files and clinical assessment. There were 244 patients, 132 men and 112 women whose mean age was 36 years. In 138 (57%) patients, all appropriate procedures and investigations, commensurate with hospital resources, had been carried out. Of 171 EPTB patients with cough for 3 weeks or longer, 138 (81%) submitted sputum specimens for smear microscopy of acid-fast bacilli (AFB). A confirmed diagnosis ofTB was made in 15 (6%) patients based on finding AFB or caseating granulomas in specimens. In 157 (64%) patients, the diagnosis of EPTB was considered to be correct. In 46 (19%) patients the diagnosis was considered to be TB, although different from the type of EPTB with which the patient was registered. In 39 (16%) patients an alternative non-TB diagnosis was made and in two (1%) patients it was not possible to make a decision. Diagnostic practices need to be improved, and ways of doing this are discussed.

Communicable disease control programmes in Malawi.

A series of half-day meetings were held between the Malawi National TB Control Programme and the other seven disease control programmes housed in the Community Health Science Unit (CHSU) to look at the structure and function of these programmes. Data were collected into a structured proforma on human resources, sources of international funding, policies and disease control activities, supportive activities, management organization, monitoring and evaluation and operational research. A number of constraints were identified, particularly in the areas of technical supervision, monitoring and evaluation and operational research. Serious consideration should be given to allow CHSU to have a more centralised and unifying role, with the aim of creating a more efficient and better-funded national communicable disease control service.

Highly active antiretroviral therapy and tuberculosis control in Africa: synergies and potential.

HIV/AIDS (human immunodeficiency virus/acquired immunodeficiency syndrome) and TB (tuberculosis) are two of the world's major pandemics, the brunt of which falls on sub-Saharan Africa. Efforts aimed at controlling HIV/AIDS have largely focused on prevention, little attention having been paid to care. Work on TB control has concentrated on case detection and treatment. HIV infection has complicated the control of tuberculosis. There is unlikely to be a decline in the number of cases of TB unless additional strategies are developed to control both this disease and HIV simultaneously. Such strategies would include active case-finding in situations where TB transmission is high, the provision of a package of care for HIV-related illness, and the application of highly active antiretroviral therapy. The latter is likely to have the greatest impact, but for this therapy to become more accessible in Africa the drugs would have to be made available through international support and a programme structure would have to be developed for its administration. It could be delivered by means of a structure based on the five-point strategy called DOTS, which has been adopted for TB control. However, it may be unrealistic to give TB control programmes the responsibility for running such a programme. A better approach might be to deliver highly active antiretroviral therapy within a comprehensive HIV/AIDS management strategy complementing the preventive work already being undertaken by AIDS control programmes. TB programmes could contribute towards the development and implementation of this strategy.

High incidence of tuberculosis in prison officers in Zomba, Malawi.

We conducted a study in four prisons in Zomba district, Malawi, to determine the tuberculosis case notification rate in prison officers during the year 2000. Of 201 prison staff, 9 (4.5%) were diagnosed with TB: 2 with smear-positive pulmonary tuberculosis (PTB), 4 with smear-negative PTB and 3 with extrapulmonary TB (EPTB). This incidence in prison officers (9/201) was significantly greater than the incidence in primary school teachers in a separate (unpublished) study in Malawi the previous year (78/4,289) (OR 2.58,[95% CI, 2.44 - 2.73], p <0.015). Expressed as annual TB case notification rates, the data for prison officers in these 4 prisons was 4,478 per 100,000, compared to 1,786 per 100,000 in teachers. There may be a high incidence of TB in prison officers. Further research needs to be carried out in this group to confirm these findings and to develop an occupational health service to reduce the risk of TB for these workers.