Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests.

Objectives: To evaluate the effect of storing commonly used rapid diagnostic tests above manufacturer-recommended temperature (at 37°C), and the accuracy of delayed reading of oral fluid kits with relevance to HIV self-testing programmes.

Design: A quality assurance study of OraQuick (OraSure), Determine HIV 1/2™ (Alere) and Uni-Gold™ (Recombigen®).

Methods: Consecutive adults (≥18y) attending Ndirande Health Centre in urban Blantyre, Malawi in January to April 2012 underwent HIV testing with two of each of the three rapid diagnostic test kits stored for 28 days at either 18°C (optimally-stored) or at 37°C (pre-incubated).

HIV policy and implementation: a national policy review and an implementation case study of a rural area of northern Malawi.

Malawi is a global leader in the design and implementation of progressive HIV policies. However, there continues to be substantial attrition of people living with HIV across the "cascade" of HIV services from diagnosis to treatment, and program outcomes could improve further. Ability to successfully implement national HIV policy, especially in rural areas, may have an impact on consistency of service uptake.

Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study.

Background: Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population.

A comparative analysis of national HIV policies in six African countries with generalized epidemics.

Objective: To compare national human immunodeficiency virus (HIV) policies influencing access to HIV testing and treatment services in six sub-Saharan African countries.

Methods: We reviewed HIV policies as part of a multi-country study on adult mortality in sub-Saharan Africa. A policy extraction tool was developed and used to review national HIV policy documents and guidelines published in Kenya, Malawi, South Africa, Uganda, the United Republic of Tanzania and Zimbabwe between 2003 and 2013.

Strategies for monitoring and evaluation of resource-limited national antiretroviral therapy programs: the two-phase design.

Background: In resource-limited settings, monitoring and evaluation (M&E) of antiretroviral treatment (ART) programs often relies on aggregated facility-level data. Such data are limited, however, because of the potential for ecological bias, although collecting detailed patient-level data is often prohibitively expensive. To resolve this dilemma, we propose the use of the two-phase design.

Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.

Importance: Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.

Objective: To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only.

Design, Setting, And Participants: Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas.

Task-sharing of HIV care and ART initiation: evaluation of a mixed-care non-physician provider model for ART delivery in rural Malawi.

Background: Expanding access to antiretroviral therapy (ART) in sub-Saharan Africa requires implementation of alternative care delivery models to traditional physician-centered approaches. This longitudinal analysis compares outcomes of patients initiated on antiretroviral therapy (ART) by non-physician and physician providers.

Methods: Adults (≥15 years) initiating ART between September 2007 and March 2010, and with >1 follow-up visit were included and classified according to the proportion of clinical visits performed by nurses or by clinical officers (≥ 80% of visits).

A novel community health worker tool outperforms WHO clinical staging for assessment of antiretroviral therapy eligibility in a resource-limited setting.

The accuracy of a novel community health worker antiretroviral therapy eligibility assessment tool was examined in community members in Blantyre, Malawi. Nurses independently performed World Health Organization (WHO) staging and CD4 counts. One hundred ten (55.

Development and validation of a global positioning system-based "map book" system for categorizing cluster residency status of community members living in high-density urban slums in Blantyre, Malawi.

A significant methodological challenge in implementing community-based cluster-randomized trials is how to accurately categorize cluster residency when data are collected at a site distant from households. This study set out to validate a map book system for use in urban slums with no municipal address systems, where classification has been shown to be inaccurate when address descriptions were used. Between April and July 2011, 28 noncontiguous clusters were demarcated in Blantyre, Malawi.

Barriers and facilitators to linkage to ART in primary care: a qualitative study of patients and providers in Blantyre, Malawi.

Introduction: Linkage from HIV testing and counselling (HTC) to initiation of antiretroviral therapy (ART) is suboptimal in many national programmes in sub-Saharan Africa, leading to delayed initiation of ART and increased risk of death. Reasons for failure of linkage are poorly understood.

Methods: Semi-structured qualitative interviews were undertaken with health providers and HIV-positive primary care patients as part of a prospective cohort study at primary health centres in Blantyre, Malawi.

Treatment initiation, program attrition and patient treatment outcomes associated with scale-up and decentralization of HIV care in rural Malawi.

Objective: To describe patient antiretroviral therapy (cART) outcomes associated with intensive decentralization of services in a rural HIV program in Malawi.

Methods: Longitudinal analysis of data from HIV-infected patients starting cART between August 2001 and December 2008 and of a cross-sectional immunovirological assessment conducted 12 (±2) months after therapy start. One-year mortality, lost to follow-up, and attrition (deaths and lost to follow-up) rates were estimated with exact Poisson 95% confidence intervals (CI) by type of care delivery and year of initiation.

Determinants and consequences of failure of linkage to antiretroviral therapy at primary care level in Blantyre, Malawi: a prospective cohort study.

Background: Poor rates of linkage from HIV diagnosis to ART initiation are a major barrier to universal coverage of ART in sub-Saharan Africa, with reasons for failure poorly understood. In the first study of this kind at primary care level, we investigated the pathway to care in the Malawian National Programme, one of the strongest in Africa.

Methods And Findings: A prospective cohort study was undertaken at two primary care clinics in Blantyre, Malawi.

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.

Suboptimal patterns of provider initiated HIV testing and counselling, antiretroviral therapy eligibility assessment and referral in primary health clinic attendees in Blantyre, Malawi.

Objective: To understand reasons for suboptimal and delayed uptake of antiretroviral therapy (ART) by describing the patterns of HIV testing and counselling (HTC) and outcomes of ART eligibility assessments in primary clinic attendees.

Methods: All clinic attendances and episodes of HTC were recorded at two clinics in Blantyre. A cohort of newly diagnosed HIV-positive adults (>15 years) was recruited and exit interviews undertaken.

How operational research influenced the scale up of antiretroviral therapy in Malawi.

The national scale up of antiretroviral therapy in Malawi is based on a public health approach, with principles and practices borrowed from the successful World Health Organization "DOTS" tuberculosis control framework. The scale up of antiretroviral therapy was under-pinned by a very strong monitoring and evaluation system, which was used to audit the scale up approach and conduct operational research to answer relevant questions. Examples of research included:- i) access to antiretroviral therapy, populations and social groups served, and how the different groups fared with regard to outcomes; ii) determining whether the quality of data at antiretroviral therapy sites was adequate and whether external supervision was needed; iii) finding feasible ways of reducing the high early mortality in patients starting treatment in both Malawi and the sub-Saharan African region; iv) the causes of loss-to-follow-up, what happened to patients who transferred out of sites and whether transfer-out patients had outcomes comparable to those who did not transfer; and v) the important question of whether antiretroviral therapy scale up reduced population mortality.

Mortality and loss to follow-up in the first year of ART: Malawi national ART programme.

Objectives: To analyse mortality, loss to follow-up (LTFU) and retention on antiretroviral treatment (ART) in the first year of ART across all age groups in the Malawi national ART programme.

Design: Cohort study including all patients who started ART in Malawi's public sector clinics between 2004 and 2007.

Methods: ART registers were photographed, information entered into a database and merged with data from clinics with electronic records.

Stigmatising attitudes among people offered home-based HIV testing and counselling in Blantyre, Malawi: construction and analysis of a stigma scale.

Background: HIV/AIDS related stigma is a major barrier to uptake of HIV testing and counselling (HTC). We assessed the extent of stigmatising attitudes expressed by participants offered community-based HTC, and their anticipated stigma from others to assess relationship with HIV test uptake. From these data, we constructed a brief stigma scale for use around the time of HIV testing.

The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi.

Background: Although HIV testing and counseling (HTC) uptake has increased dramatically in Africa, facility-based services are unlikely to ever meet ongoing need to the full. A major constraint in scaling up community and home-based HTC services is the unacceptability of receiving HTC from a provider known personally to prospective clients. We investigated the potential of supervised oral HIV self-testing from this perspective.

Antiretroviral drug supply challenges in the era of scaling up ART in Malawi.

The number of people receiving antiretroviral treatment (ART) has increased considerably in recent years and is expected to continue to grow in the coming years. A major challenge is to maintain uninterrupted supplies of antiretroviral (ARV) drugs and prevent stock outs. This article discusses issues around the management of ARVs and prevention of stock outs in Malawi, a low-income country with a high HIV/AIDS burden, and a weak procurement and supply chain management system.

Why did the scale-up of HIV treatment work? A case example from Malawi.

The national scale-up of antiretroviral therapy (ART) in Malawi is based on a public health approach, with principles and practices borrowed from the successful DOTS (directly observed treatment short course-the system used to successfully deliver antituberculosis treatment to people in some of the poorest countries of the world) tuberculosis control framework. During the first 6 years, the number of patients registered on treatment increased from 3000 to >350,000 in both the public and private sectors. The most important reasons for this success have been strong international and national leadership combined with adequate funds, a standardized approach to ART with practical guidelines, an approved national scale-up plan with clear, time-bound milestones; investment in an intensive program of training and accreditation of ART sites, quarterly supervision and monitoring of ART and operational research, rational drug forecasting and no stock-outs of drugs during the first few years, and involvement of the private sector.

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.

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.

HIV testing and antiretroviral therapy in government and mission hospitals in Malawi: 2002-2007.

HIV testing and antiretroviral therapy (ART) has scaled up tremendously in Malawi in the last 5 years. We analyzed trends of HIV testing uptake in the course of ART scale-up in 25 government and mission hospitals, which were selected because they do not receive support from non-governmental organizations. Data on numbers of clients HIV tested and on cumulative ART registrations were collected from annual country-wide situational analyses and from quarterly ART supervisory visits from 2002 to 2007.

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.