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Background: The COVID-19 vaccination programme in South Africa was rolled out in February 2021 via five delivery channels- hospitals, primary healthcare (PHC), fixed, temporary, and mobile outreach channels. In this study, we estimated the financial and economic costs of the COVID-19 vaccination programme in the first year of roll out from February 2021 to January 2022 and one month prior, in one district of South Africa, the West Rand district., Methods: Financial and economic costs were estimated from a public payer's perspective using top-down and ingredient-based costing approaches. Data were collected on costs incurred at the national level and from the West Rand district. Total cost and cost per COVID-19 vaccine dose were estimated for each of the five delivery channels implemented in the district. In addition, we estimated vaccine delivery costs which we defined as total cost exclusive of vaccine procurement costs., Results: Total financial and economic costs were estimated at US$8.5 million and US$12 million, respectively; with a corresponding cost per dose of US$15.31 (financial) and US$21.85 (economic). The two biggest total cost drivers were vaccine procurement which contributed 73% and 51% to total financial and economic costs respectively, and staff time which contributed 10% and 36% to total financial and economic costs, respectively. Total vaccine delivery costs were estimated at US$2.1 million (financial) and US$5.7 million (economic); and the corresponding cost per dose at US$3.84 (financial) and US$10.38 (economic). Vaccine delivery cost per dose (financial/economic) was estimated at US$2.93/12.84 and US$2.45/5.99 in hospitals and PHCs, respectively, and at US$7.34/20.29, US$3.96/11.89 and US$24.81/28.76 in fixed, temporary and mobile outreach sites, respectively. Staff time was the biggest economic cost driver for vaccine delivery in PHCs and hospitals while per diems and staff time were the biggest economic cost drivers for vaccine delivery in the three outreach delivery channels., Conclusion: This study offers insights for budgeting and planning of COVID-19 vaccine delivery in South Africa's public healthcare system. It also provides input for cost-effectiveness analyses to guide future strategies for maximizing vaccination coverage in the country., (© 2024. The Author(s).)

Background: South Africa (SA) has one of the highest rates of migration on the continent, largely comprised of men seeking labor opportunities in urban centers. Migrant men are at risk for challenges engaging in HIV care. However, rates of HIV and patterns of healthcare engagement among migrant men in urban Johannesburg are poorly understood., Methods: We analyzed data from 150 adult men (≥ 18 years) recruited in 10/2020-11/2020 at one of five sites in Johannesburg, Gauteng Province, SA where migrants typically gather for work, shelter, transit, or leisure: a factory, building materials store, homeless shelter, taxi rank, and public park. Participants were surveyed to assess migration factors (e.g., birth location, residency status), self-reported HIV status, and use and knowledge of HIV and general health services. Proportions were calculated with descriptive statistics. Associations between migration factors and health outcomes were examined with Fisher exact tests and logistic regression models. Internal migrants, who travel within the country, were defined as South African men born outside Gauteng Province. International migrants were defined as men born outside SA., Results: Two fifths (60/150, 40%) of participants were internal migrants and one fifth (33/150, 22%) were international migrants. More internal migrants reported living with HIV than non-migrants (20% vs 6%, p = 0.042), though in a multi-variate analysis controlling for age, being an internal migrant was not a significant predictor of self-reported HIV positive status. Over 90% all participants had undergone an HIV test in their lifetime. Less than 20% of all participants had heard of pre-exposure prophylaxis (PrEP), with only 12% international migrants having familiarity with PrEP. Over twice as many individuals without permanent residency or citizenship reported "never visiting a health facility," as compared to citizens/permanent residents (28.6% vs. 10.6%, p = 0.073)., Conclusions: Our study revealed a high proportion of migrants within our community-based sample of men and demonstrated a need for HIV and other healthcare services that effectively reach migrants in Johannesburg. Future research is warranted to further disaggregate this heterogenous population by different dimensions of mobility and to understand how to design HIV programs in ways that will address migrants' challenges., (© 2024. The Author(s).)

Background: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN)., Methods: We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15-30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15-30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15-30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention., Discussion: The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care., Trial Registration: ClinicalTrials.gov Identifier-NCT05405582. Registered: 6th June 2022., (© 2023. BioMed Central Ltd., part of Springer Nature.)

This cost-outcome study estimated, from the perspective of the service provider, the total annual cost per client on antiretroviral therapy (ART) and total annual cost per client virally suppressed (defined as < 1000 copies/ml at the time of the study) in Uganda in five ART differentiated service delivery models (DSDMs). These included both facility- and community-based models and the standard of care (SOC), known as the facility-based individual management (FBIM) model. The Ministry of Health (MOH) adopted guidelines for DSDMs in 2017 and sought to measure their costs and outcomes, in order to effectively plan for their resourcing, implementation, and scale-up. In Uganda, the standard of care (FBIM) is considered as a DSDM option for clients requiring specialized treatment and support, or for those who select not to join an alternative DSDM. Note that clients on second-line regimes and considered as "established on treatment" can join a suitable DSDM.Using retrospective client record review of a cohort of clients over a two-year period, with bottom-up collection of clients' resource utilization data, top-down collection of above-delivery level and delivery-level providers' fixed operational costs, and local unit costs. Forty-seven DSDMs located at facilities or community-based points in the four regions of Uganda were included in the study, with 653 adults on ART (> 18 years old) enrolled in a DSDM. The study found that retention in care was 98% for the sample as a whole [96-100%], and viral suppression, 91% [86-93%]. The mean cost to the provider (MOH or NGO implementers) was $152 per annum per client treated, ranging from $141 to $166. Differences among the models' costs were largely due to clients' ARV regimens and the proportions of clients on second line regimens. Service delivery costs, excluding ARVs, other medicines and laboratory tests, were modest, ranging from $9.66-16.43 per client per year. We conclude that differentiated ART service delivery in Uganda achieved excellent treatment outcomes at a cost similar to the standard of care. While large budgetary savings might not be immediately realized, the reallocation of "saved" staff time could improve health system efficiency and with their equivalent or better outcomes and large benefits to clients, client-centred differentiated models would nevertheless add great societal value., (© 2022. The Author(s).)

Background: In response to the global pandemic of COVID-19, countries around the world began imposing stay-at-home orders, restrictions on transport, and closures of businesses in early 2020. South Africa implemented a strict lockdown in March 2020 before its first COVID-19 wave started, gradually lifted restrictions between May and September 2020, and then re-imposed restrictions in December 2020 in response to its second wave. There is concern that COVID-19-related morbidity and mortality, fear of transmission, and government responses may have led to a reduction in antiretroviral treatment (ART) initiations for HIV-infected individuals in countries like South Africa., Methods: We analyzed national, public sector, facility-level data from South Africa's District Health Information System (DHIS) from January 2019 to March 2021 to quantify changes in ART initiation rates stratified by province, setting, facility size and type and compared the timing of these changes to COVID-19 case numbers and government lockdown levels. We excluded facilities with missing data, mobile clinics, and correctional facilities. We estimated the total number of ART initiations per study month for each stratum and compared monthly totals, by year., Results: At the 2471 facilities in the final data set (59% of all ART sites in the DHIS), 28% fewer initiations occurred in 2020 than in 2019. Numbers of ART initiations declined sharply in all provinces in April-June 2020, compared to the same months in 2019, and remained low for the rest of 2020, with some recovery between COVID-19 waves in October 2020 and possible improvement beginning in March 2021. Percentage reductions were largest in district hospitals, larger facilities, and urban areas. After the initial decline in April-June 2020, most provinces experienced a clear inverse relationship between COVID-19 cases and ART initiations but little relationship between ART initiations and lockdown level., Conclusions: The COVID-19 pandemic and responses to it resulted in substantial declines in the number of HIV-infected individuals starting treatment in South Africa, with no recovery of numbers during 2020. These delays may lead to worse treatment outcomes for those with HIV and potentially higher HIV transmission. Exceptional effort will be needed to sustain gains in combatting HIV., (© 2022. The Author(s).)

Background: Cryptococcal meningitis in HIV-infected patients in sub-Saharan Africa accounts for three-quarters of the global cases and 135,000 deaths per annum. Current treatment includes the use of fluconazole and amphotericin B. Recent evidence has shown that the synergistic use of flucytosine improves efficacy and reduces toxicity, however affordability and availability has hampered access to flucytosine in many countries. This study investigated the evidence and cost implications of introducing flucytosine as induction therapy for cryptococcal meningitis in HIV-infected adults in South Africa., Methods: A decision analytic cost-effectiveness and cost impact model was developed based on survival estimates from the ACTA trial and local costs for flucytosine as induction therapy in HIV-infected adults with cryptococcal meningitis in a public sector setting in South Africa. The model considered five treatment arms: (a) standard of care; 2-week course amphotericin B/fluconazole (2wk AmBd/Flu), (b) 2-week course amphotericin B/flucytosine (2wk AmBd/5FC), (c) short course; 1-week course amphotericin B/flucytosine (1wk AmBd/5FC) (d) oral course; 2-week oral fluconazole/flucytosine (oral) and e) 1-week course amphotericin B/fluconazole (1wk AmBd/Flu). A sensitivity analysis was conducted on key variables., Results: The highest total treatment costs are in the 2-week AmBd/5FC arm followed by the 2-week oral regimen, the 1-week AmBd/5FC, then standard of care with the lowest cost in the 1-week AmBd/Flu arm. Compared to the lowest cost option the 1-week flucytosine course is most cost-effective at USD119/QALY. The cost impact analysis shows that the 1-week flucytosine course has an incremental cost of just over USD293 per patient per year compared to what is currently spent on standard of care. Sensitivity analyses suggest that the model is most sensitive to life expectancy and hospital costs, particularly infusion costs and length of stay., Conclusions: The addition of flucytosine as induction therapy for the treatment of cryptococcal meningitis in patients infected with HIV is cost-effective when it is used as a 1-week AmBd/5FC regimen. Savings could be achieved with early discharge of patients as well as a reduction in the price of flucytosine.

Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems., Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance., Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification., Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

Background: The Woza Asibonisane Community Responses (CR) Programme was developed to prevent HIV infections and gender-based violence (GBV) within four provinces in South Africa. The Centre for Communication Impact (CCI) in collaboration with six partner non-governmental organizations (NGOs) implemented the programme, which was comprised of multiple types of group discussion and education activities organized and facilitated by each NGO. To date, little information exists on the cost of implementing such multi-objective, multi-activity, community-based programmes. To address this information gap, we estimated the annual cost of implementing the CR Programme for each NGO., Methods: We used standard methods to estimate the costs for each NGO, which involved a package of multiple activities targeted to distinct subpopulations in specific locations. The primary sources of information came from the implementing organizations. Costs (US dollars, 2017) are reported for each partner for one implementation year (the U.S. Government fiscal year (10/2016-09/2017). In addition to total costs disaggregated by main input categories, a common metric--cost per participant intervention hour--is used to summarize costs across partners., Results: Each activity included in the CR program involve organizing and bringing together a group of people from the target population to a location and then completing the curriculum for that activity. Activities were held in community settings (meeting hall, community center, sports grounds, schools, etc.). The annual cost per NGO varied substantially, from $260,302 to $740,413, as did scale based on estimated total participant hours, from 101,703 to 187,792 participant hours. The cost per participant hour varied from $2.8-$4.6, with NGO labor disaggregated into salaries for management and salaries for service delivery (providing the activity curriculum) contributing to the largest share of costs per participant hour., Conclusions: The cost of implementing any community-based program depends on: (1) what the program implements; (2) the resources used; and (3) unit costs for such resources. Reporting on costs alone, however, does not provide enough information to evaluate if the costs are 'too high' or 'too low' without a clearer understanding of the benefits produced by the program, and if the benefits would change if resources (and therefore costs) were changed.

Background: Those who are homeless are more prone to communicable, respiratory and cardiovascular diseases and are less likely to access healthcare services. In South Africa there are no specific public healthcare services tailored to the needs of these communities, particularly if they are immigrants. Trinity Health Services is a student-run inner-city clinic providing free healthcare to the homeless of Johannesburg, South Africa. The clinic operates two nights per month and provides treatment for mainly acute conditions. The purpose of this study was to determine the costs of establishing and operating a student-run clinic for an indigent population., Methods: This costing analysis used a mixed-methods approach combining an ingredients-based and top-down methodology. The costs, capital and recurrent, pertaining to the establishment and operating of the clinic as well as the cost of treatment per patient were identified and quantified from 1st January 2016 - 31st December 2017., Results: The capital costs incurred in establishing the clinic were calculated to be £10,968.57 (ZAR 214157.08) and included building alterations, equipment purchased, installations, furniture, application for a pharmacy license, consumables and medications. The recurrent costs per annum were estimated at £17,730.72 (ZAR 346185.54) and comprised of overheads and maintenance, rental, personnel, pharmacy license, consumables and medication. The cost of treatment per patient, included medication dispensed and consumables used in the consultation, was estimated at £3.54 (ZAR 69.05) per visit., Conclusions: This study summarised the costs of establishing and operating a student-run clinic providing pertinent information essential to the sustainability of the service. It also provides a model for costs associated with free clinics in faith-based and university settings.

Background: Systematic and transparent approaches to priority setting are needed, particularly in low-resource settings, to produce decisions that are sound and acceptable to stakeholders. The EVIDEM framework brings together Health Technology Assessment (HTA) and multi-criteria decision analysis (MCDA) by proposing a comprehensive set of decision criteria together with standardized processes to support decisionmaking. The objective of the study was to field test the framework for decisionmaking on a screening test by a private health plan in South Africa., Methods: Liquid-based cytology (LBC) for cervical cancer screening was selected by the health plan for this field test. An HTA report structured by decision criterion (14 criteria organized in the MCDA matrix and 4 contextual criteria) was produced based on a literature review and input from the health plan. During workshop sessions, committee members 1) weighted each MCDA decision criterion to express their individual perspectives, and 2) to appraise LBC, assigned scores to each MCDA criterion on the basis of the by-criterion HTA report.Committee members then considered the potential impacts of four contextual criteria on the use of LBC in the context of their health plan. Feedback on the framework and process was collected through discussion and from a questionnaire., Results: For 9 of the MCDA matrix decision criteria, 89% or more of committee members thought they should always be considered in decisionmaking. Greatest weights were given to the criteria "Budget impact", "Cost-effectiveness" and "Completeness and consistency of reporting evidence". When appraising LBC for cervical cancer screening, the committee assigned the highest scores to "Relevance and validity of evidence" and "Disease severity". Combination of weights and scores yielded a mean MCDA value estimate of 46% (SD 7%) of the potential maximum value. Overall, the committee felt the framework brought greater clarity to the decisionmaking process and was easily adaptable to different types of health interventions., Conclusions: The EVIDEM framework was easily adapted to evaluating a screening technology in South Africa, thereby broadening its applicability in healthcare decision making.