HIV and tuberculosis in prisons in sub-Saharan Africa.

Given the dual epidemics of HIV and tuberculosis in sub-Saharan Africa and evidence suggesting a disproportionate burden of these diseases among detainees in the region, we aimed to investigate the epidemiology of HIV and tuberculosis in prison populations, describe services available and challenges to service delivery, and identify priority areas for programmatically relevant research in sub-Saharan African prisons. To this end, we reviewed literature on HIV and tuberculosis in sub-Saharan African prisons published between 2011 and 2015, and identified data from only 24 of the 49 countries in the region. Where data were available, they were frequently of poor quality and rarely nationally representative. Prevalence of HIV infection ranged from 2·3% to 34·9%, and of tuberculosis from 0·4 to 16·3%; detainees nearly always had a higher prevalence of both diseases than did the non-incarcerated population in the same country. We identified barriers to prevention, treatment, and care services in published work and through five case studies of prison health policies and services in Zambia, South Africa, Malawi, Nigeria, and Benin. These barriers included severe financial and human-resource limitations and fragmented referral systems that prevent continuity of care when detainees cycle into and out of prison, or move between prisons. These challenges are set against the backdrop of weak health and criminal-justice systems, high rates of pre-trial detention, and overcrowding. A few examples of promising practices exist, including routine voluntary testing for HIV and screening for tuberculosis upon entry to South African and the largest Zambian prisons, reforms to pre-trial detention in South Africa, integration of mental health services into a health package in selected Malawian prisons, and task sharing to include detainees in care provision through peer-educator programmes in Rwanda, Zimbabwe, Zambia, and South Africa. However, substantial additional investments are required throughout sub-Saharan Africa to develop country-level policy guidance, build human-resource capacity, and strengthen prison health systems to ensure universal access to HIV and tuberculsosis prevention, treatment, and care of a standard that meets international goals and human rights obligations.

Scaling-up antiretroviral therapy in Malawi.

PROBLEM: In Malawi, health-system constraints meant that only a fraction of people infected with human immunodeficiency virus (HIV) and in immediate need of antiretroviral treatment (ART) received treatment. APPROACH: In 2004, the Malawian Ministry of Health launched plans to scale-up ART nationwide, adhering to the principle of equity to ensure fair geographical access to therapy. A public health approach was used with standardized training and treatment and regular supervision and monitoring of the programme. LOCAL SETTING: Before the scale-up, an estimated 930 000 people in Malawi were HIV-infected, with 170 000 in immediate need of ART. About 3000 patients were on ART in nine clinics. RELEVANT CHANGES: By December 2015, cumulatively 872 567 patients had been started on ART from 716 clinics, following national treatment protocols and using the standard monitoring system. LESSONS LEARNT: Strong national leadership allowed the ministry of health to implement a uniform system for scaling-up ART and provided benchmarks for implementation on the ground. New systems of training staff and accrediting health facilities enabled task-sharing and decentralization to peripheral health centres and a standardized approach to starting and monitoring ART. A system of quarterly supervision and monitoring, into which operational research was embedded, ensured stocks of drug supplies at facilities and adherence to national treatment guidelines.

Act local, think global: how the Malawi experience of scaling up antiretroviral treatment has informed global policy.

The scale-up of antiretroviral therapy (ART) in Malawi was based on a public health approach adapted to its resource-poor setting, with principles and practices borrowed from the successful tuberculosis control framework. From 2004 to 2015, the number of new patients started on ART increased from about 3000 to over 820,000. Despite being a small country, Malawi has made a significant contribution to the 15 million people globally on ART and has also contributed policy and service delivery innovations that have supported international guidelines and scale up in other countries. The first set of global guidelines for scaling up ART released by the World Health Organization (WHO) in 2002 focused on providing clinical guidance. In Malawi, the ART guidelines adopted from the outset a more operational and programmatic approach with recommendations on health systems and services that were needed to deliver HIV treatment to affected populations. Seven years after the start of national scale-up, Malawi launched a new strategy offering all HIV-infected pregnant women lifelong ART regardless of the CD4-cell count, named Option B+. This strategy was subsequently incorporated into a WHO programmatic guide in 2012 and WHO ART guidelines in 2013, and has since then been adopted by the majority of countries worldwide. In conclusion, the Malawi experience of ART scale-up has become a blueprint for a public health response to HIV and has informed international efforts to end the AIDS epidemic by 2030.

Improving data quality and supervision of antiretroviral therapy sites in Malawi: an application of Lot Quality Assurance Sampling.

BACKGROUND: High quality program data is critical for managing, monitoring, and evaluating national HIV treatment programs. By 2009, the Malawi Ministry of Health had initiated more than 270,000 patients on HIV treatment at 377 sites. Quarterly supervision of these antiretroviral therapy (ART) sites ensures high quality care, but the time currently dedicated to exhaustive record review and data cleaning detracts from other critical components. The exhaustive record review is unlikely to be sustainable long term because of the resources required and increasing number of patients on ART. This study quantifies the current levels of data quality and evaluates Lot Quality Assurance Sampling (LQAS) as a tool to prioritize sites with low data quality, thus lowering costs while maintaining sufficient quality for program monitoring and patient care. METHODS: In January 2010, a study team joined supervision teams at 19 sites purposely selected to reflect the variety of ART sites. During the exhaustive data review, the time allocated to data cleaning and data discrepancies were documented. The team then randomly sampled 76 records from each site, recording secondary outcomes and the time required for sampling. RESULTS: At the 19 sites, only 1.2% of records had discrepancies in patient outcomes and 0.4% in treatment regimen. However, data cleaning took 28.5 hours in total, suggesting that data cleaning for all 377 ART sites would require over 350 supervision-hours quarterly. The LQAS tool accurately identified the sites with the low data quality, reduced the time for data cleaning by 70%, and allowed for reporting on secondary outcomes. CONCLUSIONS: Most sites maintained high quality records. In spite of this, data cleaning required significant amounts of time with little effect on program estimates of patient outcomes. LQAS conserves resources while maintaining sufficient data quality for program assessment and management to allow for quality patient care.

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.

Keeping health facilities safe: one way of strengthening the interaction between disease-specific programmes and health systems.

The debate on the interaction between disease-specific programmes and health system strengthening in the last few years has intensified as experts seek to tease out common ground and find solutions and synergies to bridge the divide. Unfortunately, the debate continues to be largely academic and devoid of specificity, resulting in the issues being irrelevant to health care workers on the ground. Taking the theme 'What would entice HIV- and tuberculosis (TB)-programme managers to sit around the table on a Monday morning with health system experts', this viewpoint focuses on infection control and health facility safety as an important and highly relevant practical topic for both disease-specific programmes and health system strengthening. Our attentions, and the examples and lessons we draw on, are largely aimed at sub-Saharan Africa where the great burden of TB and HIV / AIDS resides, although the principles we outline would apply to other parts of the world as well. Health care infections, caused for example by poor hand hygiene, inadequate testing of donated blood, unsafe disposal of needles and syringes, poorly sterilized medical and surgical equipment and lack of adequate airborne infection control procedures, are responsible for a considerable burden of illness amongst patients and health care personnel, especially in resource-poor countries. Effective infection control in a district hospital requires that all the components of a health system function well: governance and stewardship, financing,infrastructure, procurement and supply chain management, human resources, health information systems, service delivery and finally supervision. We argue in this article that proper attention to infection control and an emphasis on safe health facilities is a concrete first step towards strengthening the interaction between disease-specific programmes and health systems where it really matters ­ for patients who are sick and for the health care workforce who provide the care and treatment.

Burden of cryptococcal meningitis in Malawi.

There is little information about the national burden of cryptococcal meningitis (CM) in African countries affected by the HIV/AIDS epidemic. From April 2005 onwards, we used national supervision visits of all health facilities that provided antiretroviral therapy to collect data on the number of new patients diagnosed and treated for CM in the previous quarters - using mainly fluconazole registers. For two 12-month reporting periods, there were 2125 and 2464 patients suffering from CM, giving an estimated annual incidence of 2.2% and 2.6%, respectively, of those infected with HIV in Malawi. Between 40-50% of all patients with CM were diagnosed and treated at central hospitals; no more than 1% were diagnosed and treated at smaller antiretroviral therapy sites. These data are useful for quantifying the need for better diagnostic reagents and antifungal drugs.

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.

Different delivery models for antiretroviral therapy in sub-Saharan Africa in the context of 'universal access'.

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.

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.

Lessons Learned From Option B+ in the Evolution Toward "Test and Start" From Malawi, Cameroon, and the United Republic of Tanzania.

The acceleration of prevention of mother-to-child transmission (PMTCT) activities, coupled with the rollout of 2010 World Health Organization (WHO) guidelines, led to important discussions and innovations at global and country levels. One paradigm-shifting innovation was Option B+ in Malawi. It was later included in WHO guidelines and eventually adopted by all 22 Global Plan priority countries. This article presents Malawi's experience with designing and implementing Option B+ and provides complementary narratives from Cameroon and Tanzania. Malawi's HIV program started in 2002, but by 2009, the PMTCT program was lagging far behind the antiretroviral therapy (ART) program because of numerous health system challenges. When WHO recommended Option A and Option B for PMTCT in 2010, it was clear that Malawi's HIV program would not be able to successfully implement either option without increasing existing barriers to PMTCT services and potentially decreasing women's access to care. Subsequent stakeholder discussions led to the development of Option B+. Operationalizing Option B+ required several critical considerations, including the complete integration of ART and PMTCT programs, systematic reduction of barriers to facilitate doubling the number of ART sites in less than a year, building consensus with stakeholders, and securing additional resources for the new program. During the planning and implementation process, several lessons were learned which are considerations for countries transitioning to "treat-all": Comprehensive change requires effective government leadership and coordination; national clinical guidelines must accommodate health system limitations; ART services and commodities should be decentralized within facilities; the general public should be well informed about major changes in the national HIV program; and patients should be educated on clinic processes to improve program monitoring.

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.

Planning for health sector reform in post-conflict situations: Kosovo 1999-2000.

The restoration and development of health care systems in post-conflict situations and complex emergencies are attracting attention. Kosovo is unique in being a post-conflict situation, in a former socialist country, with an unclear political future, under temporary UN administration. The World Health Organization (WHO) led a process of developing a health policy framework for the emergency period that included elements of health sector reform, a somewhat controversial initiative. Reform elements of the policy were consistent with normative health policies in much of eastern and central Europe. There was tension between the need to have a policy in place rapidly and the desire to be participatory. Policy to deal with emergency situations that is not available at the time required is of limited value. Although there was some tension between relief and development agendas, the policy process did direct significant resources and effort in directions that contributed to longer-term reform and development. A policy framework does not ensure compliance with policy unless issues of authority, mandate, and leadership are clear. A rapidly developed health policy framework at the onset of an emergency is desirable. Policy developers should be experienced, seen as being neutral and be relatively independent of any specific donor or interest group. WHO is well situated to play this role if it meets certain conditions.