Returning HIV-1 viral load results to participant-selected health facilities in national Population-based HIV Impact Assessment (PHIA) household surveys in three sub-Saharan African Countries, 2015 to 2016.

INTRODUCTION: Logistical complexities of returning laboratory test results to participants have precluded most population-based HIV surveys conducted in sub-Saharan Africa from doing so. For HIV positive participants, this presents a missed opportunity for engagement into clinical care and improvement in health outcomes. The Population-based HIV Impact Assessment (PHIA) surveys, which measure HIV incidence and the prevalence of viral load (VL) suppression in selected African countries, are returning VL results to health facilities specified by each HIV positive participant within eight weeks of collection. We describe the performance of the specimen and data management systems used to return VL results to PHIA participants in Zimbabwe, Malawi and Zambia. METHODS: Consenting participants underwent home-based counseling and HIV rapid testing as per national testing guidelines; all confirmed HIV positive participants had VL measured at a central laboratory on either the Roche CAP/CTM or Abbott m2000 platform. On a bi-weekly basis, a dedicated data management team produced logs linking the VL test result with the participants' contact information and preferred health facility; project staff sent test results confidentially via project drivers, national courier systems, or electronically through an adapted short message service (SMS). Participants who provided cell phone numbers received SMS or phone call alerts regarding availability of VL results. RESULTS AND DISCUSSION: From 29,634 households across the three countries, 78,090 total participants 0 to 64 years in Zimbabwe and Malawi and 0 to 59 years in Zambia underwent blood draw and HIV testing. Of the 8391 total HIV positive participants identified, 8313 (99%) had VL tests performed and 8245 (99%) of these were returned to the selected health facilities. Of the 5979 VL results returned in Zimbabwe and Zambia, 85% were returned within the eight-week goal with a median turnaround time of 48 days (IQR: 33 to 61). In Malawi, where exact return dates were unavailable all 2266 returnable results reached the health facilities by 11 weeks. CONCLUSIONS: The first three PHIA surveys returned the vast majority of VL results to each HIV positive participant's preferred health facility within the eight-week target. Even in the absence of national VL monitoring systems, a system to return VL results from a population-based survey is feasible, but it requires developing laboratory and data management systems and dedicated staff. These are likely important requirements to strengthen return of results systems in routine clinical care.

Impact of Facility- and Community-Based Peer Support Models on Maternal Uptake and Retention in Malawi's Option B+ HIV Prevention of Mother-to-Child Transmission Program: A 3-Arm Cluster Randomized Controlled Trial (PURE Malawi).

BACKGROUND: Many sub-Saharan African countries have adopted Option B+, a prevention of mother-to-child transmission approach providing HIV-infected pregnant and lactating women with immediate lifelong antiretroviral therapy. High maternal attrition has been observed in Option B+. Peer-based support may improve retention. METHODS: A 3-arm stratified cluster randomized controlled trial was conducted in Malawi to assess whether facility- and community-based peer support would improve Option B+ uptake and retention compared with standard of care (SOC). In SOC, no enhancements were made (control). In facility-based and community-based models, peers provided patient education, support groups, and patient tracing. Uptake was defined as attending a second scheduled follow-up visit. Retention was defined as being alive and in-care at 2 years without defaulting. Attrition was defined as death, default, or stopping antiretroviral therapy. Generalized estimating equations were used to estimate risk differences (RDs) in uptake. Cox proportional hazards regression with shared frailties was used to estimate hazard of attrition. RESULTS: Twenty-one facilities were randomized and enrolled 1269 women: 447, 428, and 394 in facilities that implemented SOC, facility-based, and community-based peer support models, respectively. Mean age was 27 years. Uptake was higher in facility-based (86%; RD: 6%, confidence interval [CI]: -3% to 15%) and community-based (90%; RD: 9%, CI: 1% to 18%) models compared with SOC (81%). At 24 months, retention was higher in facility-based (80%; RD: 13%, CI: 1% to 26%) and community-based (83%; RD: 16%, CI: 3% to 30%) models compared with SOC (66%). CONCLUSIONS: Facility- and community-based peer support interventions can benefit maternal uptake and retention in Option B+.

Correction: Voluntary Medical Male Circumcision for HIV Prevention in Malawi: Modeling the Impact and Cost of Focusing the Program by Client Age and Geography.

[This corrects the article DOI: 10.1371/journal.pone.0156521.].

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.

Voluntary Medical Male Circumcision for HIV Prevention in Malawi: Modeling the Impact and Cost of Focusing the Program by Client Age and Geography.

BACKGROUND: In 2007, the World Health Organization (WHO) recommended scaling up voluntary medical male circumcision (VMMC) in priority countries with high HIV prevalence and low male circumcision (MC) prevalence. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), an estimated 5.8 million males had undergone VMMC by the end of 2013. Implementation experience has raised questions about the need to refocus VMMC programs on specific subpopulations for the greatest epidemiological impact and programmatic effectiveness. As Malawi prepared its national operational plan for VMMC, it sought to examine the impacts of focusing on specific subpopulations by age and region. METHODS: We used the Decision Makers' Program Planning Toolkit, Version 2.0, to study the impact of scaling up VMMC to different target populations of Malawi. National MC prevalence by age group from the 2010 Demographic and Health Survey was scaled according to the MC prevalence for each district and then halved, to adjust for over-reporting of circumcision. In-country stakeholders advised a VMMC unit cost of $100, based on implementation experience. We derived a cost of $451 per patient-year for antiretroviral therapy from costs collected as part of a strategic planning exercise previously conducted in- country by UNAIDS. RESULTS: Over a fifteen-year period, circumcising males ages 10-29 would avert 75% of HIV infections, and circumcising males ages 10-34 would avert 88% of infections, compared to the current strategy of circumcising males ages 15-49. The Ministry of Health's South West and South East health zones had the lowest cost per HIV infection averted. Moreover, VMMC met WHO's definition of cost-effectiveness (that is, the cost per disability-adjusted life-year [DALY] saved was less than three times the per capita gross domestic product) in all health zones except Central East. Comparing urban versus rural areas in the country, we found that circumcising men in urban areas would be both cost-effective and cost-saving, with a VMMC cost per DALY saved of $120 USD and with 15 years of VMMC implementation resulting in lifetime HIV treatment costs savings of $331 million USD. CONCLUSIONS: Based on the age analyses and programmatic experience, Malawi's VMMC operational plan focuses on males ages 10-34 in all districts in the South East and South West zones, as well as Lilongwe (an urban district in the Central zone). This plan covers 14 of the 28 districts in the country.

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. Specifically, when the outcome of interest is binary, the two-phase design provides a framework within which researchers can resolve ecological bias through the collection of patient-level data on a sub-sample of individuals while making use of the routinely collected aggregated data to obtain potentially substantial efficiency gains. METHODS: Between 2005-2007, the Malawian Ministry of Health conducted a one-time cross-sectional survey of 82,887 patients registered at 189 ART clinics. Using these patient data, an aggregated dataset is constructed to mimic the type of data that it routinely available. A hypothetical study of risk factors for patient outcomes at 6 months post-registration is considered. Analyses are conducted based on: (i) complete patient-level data; (ii) aggregated data; (iii) a hypothetical case-control study; (iv) a hypothetical two-phase study stratified on clinic type; and, (v) a hypothetical two-phase study stratified on clinic type and registration year. A simulation study is conducted to compare statistical power to detect an interaction between clinic type and year of registration across the designs. RESULTS: Analyses and conclusions based solely on aggregated data may suffer from ecological bias. Collecting and analyzing patient data using either a case-control or two-phase design resolves ecological bias to provide valid conclusions. To detect the interaction between clinic type and year of registration, the case-control design would require a prohibitively large sample size. In contrast, a two-phase design that stratifies on clinic and year of registration achieves greater than 85% power with as few as 1,000 patient samples. CONCLUSIONS: Two-phase designs have the potential to augment current M&E efforts in resource-limited settings by providing a framework for the collection and analysis of patient data. The design is cost-efficient in the sense that it often requires far fewer patients to be sampled when compared to standard designs.

Multi-country analysis of treatment costs for HIV/AIDS (MATCH): facility-level ART unit cost analysis in Ethiopia, Malawi, Rwanda, South Africa and Zambia.

BACKGROUND: Today's uncertain HIV funding landscape threatens to slow progress towards treatment goals. Understanding the costs of antiretroviral therapy (ART) will be essential for governments to make informed policy decisions about the pace of scale-up under the 2013 WHO HIV Treatment Guidelines, which increase the number of people eligible for treatment from 17.6 million to 28.6 million. The study presented here is one of the largest of its kind and the first to describe the facility-level cost of ART in a random sample of facilities in Ethiopia, Malawi, Rwanda, South Africa and Zambia. METHODS & FINDINGS: In 2010-2011, comprehensive data on one year of facility-level ART costs and patient outcomes were collected from 161 facilities, selected using stratified random sampling. Overall, facility-level ART costs were significantly lower than expected in four of the five countries, with a simple average of $208 per patient-year (ppy) across Ethiopia, Malawi, Rwanda and Zambia. Costs were higher in South Africa, at $682 ppy. This included medications, laboratory services, direct and indirect personnel, patient support, equipment and administrative services. Facilities demonstrated the ability to retain patients alive and on treatment at these costs, although outcomes for established patients (2-8% annual loss to follow-up or death) were better than outcomes for new patients in their first year of ART (77-95% alive and on treatment). CONCLUSIONS: This study illustrated that the facility-level costs of ART are lower than previously understood in these five countries. While limitations must be considered, and costs will vary across countries, this suggests that expanded treatment coverage may be affordable. Further research is needed to understand investment costs of treatment scale-up, non-facility costs and opportunities for more efficient resource allocation.

Cost-effectiveness analysis of Option B+ for HIV prevention and treatment of mothers and children in Malawi.

BACKGROUND: The Ministry of Health in Malawi is implementing a pragmatic and innovative approach for the management of all HIV-infected pregnant women, termed Option B+, which consists of providing life-long antiretroviral treatment, regardless of their CD4 count or clinical stage. Our objective was to determine if Option B+ represents a cost-effective option. METHODS: A decision model simulates the disease progression of a cohort of HIV-infected pregnant women receiving prophylaxis and antiretroviral therapy, and estimates the number of paediatric infections averted and maternal life years gained over a ten-year time horizon. We assess the cost-effectiveness from the Ministry of Health perspective while taking into account the practical realities of implementing ART services in Malawi. RESULTS: If implemented as recommended by the World Health Organization, options A, B and B+ are equivalent in preventing new infant infections, yielding cost effectiveness ratios between US$ 37 and US$ 69 per disability adjusted life year averted in children. However, when the three options are compared to the current practice, the provision of antiretroviral therapy to all mothers (Option B+) not only prevents infant infections, but also improves the ten-year survival in mothers more than four-fold. This translates into saving more than 250,000 maternal life years, as compared to mothers receiving only Option A or B, with savings of 153,000 and 172,000 life years respectively. Option B+ also yields favourable incremental cost effectiveness ratios (ICER) of US$ 455 per life year gained over the current practice. CONCLUSION: In Malawi, Option B+ represents a favorable policy option from a cost-effectiveness perspective to prevent future infant infections, save mothers' lives and reduce orphanhood. Although Option B+ would require more financial resources initially, it would save societal resources in the long-term and represents a strategic option to simplify and integrate HIV services into maternal, newborn and child health programmes.

Monitoring the impact of decentralised chronic care services on patient travel time in rural Africa--methods and results in Northern Malawi.

BACKGROUND: Decentralised health services form a key part of chronic care strategies in resource-limited settings by reducing the distance between patient and clinic and thereby the time and costs involved in travelling. However, few tools exist to evaluate the impact of decentralisation on patient travel time or what proportion of patients attend their nearest clinic. Here we develop methods to monitor changes in travel time, using data from the antiretroviral therapy (ART) roll-out in a rural district in North Malawi. METHODS: Clinic position was combined with GPS information on the home village of patients accessing ART services in Karonga District (North Malawi) between July 2005 and July 2009. Potential travel time was estimated as the travel time for an individual attending their nearest clinic, and estimated actual travel time as the time to the clinic attended. This allowed us to calculate changes in potential and actual travel time as new clinics opened and track the proportion and origin of patients not accessing their nearest clinic. RESULTS: The model showed how the opening of further ART clinics in Karonga District reduced median potential travel time from 83 to 43 minutes, and median actual travel time fell from 83 to 47 minutes. The proportion of patients not attending their nearest clinic increased from 6% when two clinics were open, to 12% with four open. DISCUSSION: Integrating GPS information with patient data shows the impact of decentralisation on travel time and clinic choice to inform policy and research questions. In our case study, travel time decreased, accompanied by an increased uptake of services. However, the model also identified an increasing proportion of ART patients did not attend their nearest clinic.

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.

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. The answers to these questions had an important influence on how treatment was delivered in the country, and show the value of this work within a programme setting. Key generic lessons include the importance of i) research questions being relevant to programme needs, ii) studies being coordinated, designed and undertaken within a programme, iii) study findings being disseminated at national stakeholder meetings and through publications in peer-reviewed journals and iv) research being used to influence policy and practice, improve programme performance and ultimately patient treatment outcomes.

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. This system for ARVs, paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and bypassing the government Central Medical Stores, is in place, using the United Nations Children's Fund's (UNICEF's) procurement services. The system, managed by a handful of people who spend limited time on supply management, is characterized by a centrally coordinated quantification based on verified data from all national ART clinics, parallel procurement through UNICEF, and direct distribution to ART clinics. The model worked well in the first years of the ART programme with a single first-line ARV regimen, but with more regimens becoming available (e.g., alternative first-line, second-line and paediatric regimens), it has become more difficult to administer. Managing supplies through a parallel system has the advantage that weaknesses in the national system have limited influence on the ARV procurement and supply chain management system. However, as the current system operates without a central warehouse and national buffer stock capacity, it diminishes the ability to prevent ARV stock outs. The process of ordering ARVs, from the time that estimates are made to the arrival of supplies in health facilities, takes approximately one year. Addressing the challenges involved in maintaining ARVs through an efficient procurement and supply chain management system that prevents ARV stock outs through the establishment of a dedicated procurement team, a central warehouse and/or national buffer stock is a priority.