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Background: In South Africa, replacing smear microscopy with Xpert-MTB/RIF (Xpert) for tuberculosis diagnosis did not reduce mortality and was cost-neutral. The unchanged mortality has been attributed to suboptimal Xpert implementation. We developed a mathematical model to explore how complementary investments may improve cost-effectiveness of the tuberculosis diagnostic algorithm. Methods: Complementary investments in the tuberculosis diagnostic pathway were compared to the status quo. Investment scenarios following an initial Xpert test included actions to reduce pre-treatment loss-to-follow-up; supporting same-day clinical diagnosis of tuberculosis after a negative result; and improving access to further tuberculosis diagnostic tests following a negative result. We estimated costs, deaths and disability-adjusted-life-years (DALYs) averted from provider and societal perspectives. Sensitivity analyses explored the mediating influence of behavioural, disease- and organisational characteristics on investment effectiveness. Findings: Among a cohort of symptomatic patients tested for tuberculosis, with an estimated active tuberculosis prevalence of 13%, reducing pre-treatment loss-to-follow-up from ~20% to ~0% led to a 4% (uncertainty interval [UI] 3; 4%) reduction in mortality compared to the Xpert scenario. Improving access to further tuberculosis diagnostic tests from ~4% to 90% among those with an initial negative Xpert result reduced overall mortality by 28% (UI 27; 28) at $39.70/ DALY averted. Effectiveness of investment scenarios to improve access to further diagnostic tests was dependent on a high return rate for follow-up visits. Interpretation: Investing in direct and indirect costs to support the TB diagnostic pathway is potentially highly cost-effective. [ABSTRACT FROM AUTHOR]

Purpose: Estimating the incremental costs of scaling-up novel technologies in low-income and middle-income countries is a methodologically challenging and substantial empirical undertaking, in the absence of routine cost data collection. We demonstrate a best practice pragmatic approach to estimate the incremental costs of new technologies in low-income and middle-income countries, using the example of costing the scale-up of Xpert Mycobacterium tuberculosis (MTB)/resistance to riframpicin (RIF) in South Africa.Materials and Methods: We estimate costs, by applying two distinct approaches of bottom-up and top-down costing, together with an assessment of processes and capacity.Results: The unit costs measured using the different methods of bottom-up and top-down costing, respectively, are $US16.9 and $US33.5 for Xpert MTB/RIF, and $US6.3 and $US8.5 for microscopy. The incremental cost of Xpert MTB/RIF is estimated to be between $US14.7 and $US17.7. While the average cost of Xpert MTB/RIF was higher than previous studies using standard methods, the incremental cost of Xpert MTB/RIF was found to be lower.Conclusion: Costs estimates are highly dependent on the method used, so an approach, which clearly identifies resource-use data collected from a bottom-up or top-down perspective, together with capacity measurement, is recommended as a pragmatic approach to capture true incremental cost where routine cost data are scarce. [ABSTRACT FROM AUTHOR]

Social protection against the cost of illness is a central policy objective of Universal Health Coverage and the post-2015 Global strategy for Tuberculosis (TB). Understanding the economic burden associated with TB illness and care is key to identifying appropriate interventions towards achieving this target. The aims of this study were to identify points in patient pathways from start of TB symptoms to treatment completion where interventions could be targeted to reduce the economic impact on patients and households, and to identify those most vulnerable to these costs. Two cohorts of patients accessing TB services from ten clinics in four provinces in South Africa were surveyed between July 2012 and June 2013. One cohort of 351 people with suspected TB were interviewed at the point of receiving a TB diagnostic and followed up six months later. Another cohort of 168 patients on TB treatment, at the same ten facilities, was interviewed at two-months and five-months on treatment. Patients were asked about their health-seeking behaviour, associated costs, income loss, and coping strategies used. Patients incurred the greatest share of TB episode costs (41%) prior to starting treatment, with the largest portion of these costs being due to income loss. Poorer patients incurred higher direct costs during treatment than those who were less poor but only 5% of those interviewed were accessing cash-transfers during treatment. Indirect costs accounted for 52% of total episode cost. Despite free TB diagnosis and care in South Africa, patients incur substantial direct and indirect costs particularly prior to starting treatment. The poorest group of patients were incurring higher costs, with fewer resources to pay for it. Both the direct and indirect cost of illness should be taken into account when setting levels of financial protection and social support, to prevent TB illness from pushing the poor further into poverty. [ABSTRACT FROM AUTHOR]

Background: A scarcity of human resources for health has been identified as one of the primary constraints to the scale-up of the provision of Anti-Retroviral Treatment (ART). In South Africa there is a particularly severe lack of pharmacists. The study aims to compare two task-shifting approaches to the dispensing of ART: Indirectly Supervised Pharmacist's Assistants (ISPA) and Nurse-based pharmaceutical care models against the standard of care which involves a pharmacist dispensing ART.Methods: A cross-sectional mixed methods study design was used. Patient exit interviews, time and motion studies, expert interviews and staff costs were used to conduct a costing from the societal perspective. Six facilities were sampled in the Western Cape province of South Africa, and 230 patient interviews conducted.Results: The ISPA model was found to be the least costly task-shifting pharmaceutical model. However, patients preferred receiving medication from the nurse. This related to a fear of stigma and being identified by virtue of receiving ART at the pharmacy.Conclusions: While these models are not mutually exclusive, and a variety of pharmaceutical care models will be necessary for scale up, it is useful to consider the impact of implementing these models on the provider, patient access to treatment and difficulties in implementation. [ABSTRACT FROM AUTHOR]

Purpose: To quantify costs to patients of accessing HIV care prior to ART initiation., Materials and Methods: Using a cross-sectional study design, costs incurred by HIV-positive patients prior to ART initiation were estimated at urban primary healthcare facilities in South Africa. Costs included direct costs, indirect (productivity) costs, carer and coping costs (value of assets sold and money borrowed). The percentage of individual income spent on healthcare was calculated and compared by patient income tertiles and CD4 count strata., Results: 289 patients (69% female, mean age 37 (SD: 10) years, median CD4 317 (IQR: 138-494) cells/mm3) were interviewed. The total mean monthly cost of pre-ART care was US$15.71. Indirect costs accounted for $2.59 (16.49%) of this when time was valued using the patient's reported income. The mean monthly patient costs were $31.61, $12.78, $12.65 and $11.93 for those with a CD4 count <100, 101-350, 351-500 and >500 cells/mm3 respectively. The percentage of individual income spent on healthcare was 7.25% for those with a CD4 count <100 cells/mm3 and 4.05% for those with a CD4 count >500 cells/mm3., Conclusions: Despite the provision of charge-free services at public clinics, care prior to ART initiation can be costly, particularly for the poor and unemployed. Our study adds to the growing body of evidence that highlights the need to consider policies to reduce the economic barriers to HIV service access, particularly for low income or unwell patient groups, such as improving access to disability grants., Competing Interests: The authors have declared that no competing interests exist.

Background: The severe shortage of pharmacists is an important limitation to providing antiretroviral treatment (ART) in resource-limited countries. Two task-shifting pharmaceutical care models have been developed to address this in South Africa, namely indirectly supervised pharmacist assistant (ISPA) and nurse-managed models. This study compared pharmaceutical care quality, patient clinical outcomes, and provider staff costs between these models., Methods: An analysis of pharmaceutical quality audits, patient clinical data, and staff costing data collected at 7 ISPA and 8 nurse-managed facilities was undertaken. Pharmaceutical audits were conducted by pharmacists using a standardized tool. Routine clinical data were collected prospectively at patient visits, and staff human resources costs were analyzed., Results: Overall pharmaceutical care quality scores were higher at ISPA sites than nurse-managed sites; 88.8% vs. 79.9%, respectively; risk ratio (ISPA vs. nurse) = 1.11 (95% confidence interval: 1.09 to 1.13; P < 0.0001). Mean provider pharmaceutical-related human resources costs per patient visit and per item dispensed were 29% and 49% lower, respectively, at ISPA facilities. At ISPA facilities, patient attrition was observed to be lower and viral suppression higher than at nurse-managed sites., Conclusion: The ISPA model had a higher quality of pharmaceutical care and was less costly to implement. Further expansion of this model or integrating it with nurse-managed ART may enhance the cost-efficient scale-up of ART programs in Sub-Saharan Africa.

Background: A pragmatic three-tiered approach to monitor the world's largest antiretroviral treatment (ART) programme was adopted by the South African National Department of Health in 2010. With the rapid expansion of the programme, the limitations of the paper-based register (tier 1) were the catalyst for implementation of the stand-alone electronic register (tier 2), which offers simple digitisation of the paper-based register. This article engages with theory on implementation to identify and contextualise enabling and constraining factors for implementation of the electronic register, to describe experiences and use of the register, and to make recommendations for implementation in similar settings where standardisation of ART monitoring and evaluation has not been achieved., Methods: We conducted a qualitative evaluation of the roll-out of the register. This comprised twenty in-depth interviews with a diverse sample of stakeholders at facility, sub-district, and district levels of the health system. Facility-level participants were selected across five sub-districts, including one facility per sub-district. Responses were coded and analysed using a thematic approach. An implementation science framework guided interpretation of the data., Results & Discussion: We identified the following seven themes: 1) ease of implementation, 2) perceived value of an electronic M&E system, 3) importance of stakeholder engagement, 4) influence of a data champion, 5) operational and logistical factors, 6) workload and role clarity, and 7) importance of integrating the electronic register with routine facility monitoring and evaluation. Interpreting our findings through an implementation theory enabled us to construct the scaffolding for implementation across the five facility-settings. This approach illustrated that implementation was not a linear process but occurred at two nodes: at the adoption of the register for roll-out, and at implementation at facility-level., Conclusion: In this study we found that relative advantage of an intervention and stakeholder engagement are critical to implementation. We suggest that without these aspects of implementation, formative and summative outcomes of implementation at both the adoption and coalface stages of implementation would be negatively affected.