Field performance and cost-effectiveness of a point-of-care triage test for HIV virological failure in Southern Africa.

INTRODUCTION: Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high-burden, limited-resources settings. Chemokine IP-10 (interferon gamma-induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve to predict virological failure (VF) and to triage patients requiring VL testing. We assessed the field performance of a semi-quantitative IP-10 lateral flow assay (LFA) for VF screening in South Africa, and the cost-effectiveness of its implementation in Mozambique. METHODS: A cross-sectional study was conducted between June and December 2021 in three primary health clinics in the Western Cape. Finger prick capillary blood was collected from adults on ART for ≥1 year for direct application onto the IP-10 LFA (index test) and compared with a plasma VL result ≤1 month prior (reference test). We estimated the area under the receiver operating characteristic curves (AUC), sensitivity and specificity, to evaluate IP-10 LFA prediction of VF (VL>1000 copies/ml). A decision tree model was used to investigate the cost-effectiveness of integrating IP-10 LFA combined with VL testing into the current Mozambican ART monitoring strategy. Averted disability-adjusted life years (DALYs) and HIV acquisitions, and incremental cost-effectiveness ratios were estimated. RESULTS: Among 209 participants (median age 38 years and 84% female), 18% had VF. Median IP-10 LFA values were higher among individuals with VF compared to those without (24.0 vs. 14.6; p<0.001). The IP-10 LFA predicted VF with an AUC = 0.76 (95% confidence interval (CI) 0.67-0.85), 91.9% sensitivity (95% CI 78.1-98.3) and 35.1% specificity (95% CI 28.0-42.7). Integrating the IP-10 LFA in a setting with 20% VF prevalence and 61% VL testing coverage could save 13.0% of costs and avert 14.9% of DALYs and 55.7% new HIV acquisitions. Furthermore, its introduction was estimated to reduce the total number of routine VL tests required for ART monitoring by up to 68%. CONCLUSIONS: The IP-10 LFA is an effective VF triage test for routine ART monitoring. Combining a highly sensitive, low-cost IP-10 LFA-based screening with targeted VL confirmatory testing could result in significant healthcare quality improvements and cost savings in settings with limited access to VL testing.

Effects of a temporary suspension of community-based health insurance in Kwara State, North-Central, Nigeria.

INTRODUCTION: a subsidized community health insurance programme in Kwara State, Nigeria was temporarily suspended in 2016 in anticipation of the roll-out of a state-wide health insurance scheme. This article reports the adverse consequences of the scheme´s suspension on enrollees´ healthcare utilization. METHODS: a mixed-methods study was carried out in Kwara State, Nigeria, in 2018 using a semi-quantitative cross-sectional survey amongst 600 former Kwara community health insurance clients, and in-depth interviews with 24 clients and 29 participating public and private healthcare providers in the program. Both quantitative and qualitative data were analyzed and triangulated. RESULTS: most of former enrollees (95.3%) kept utilizing programme facilities after the suspension, mainly because of the high quality of care. However, majority of the enrollees (95.8%) reverted to out-of-pocket payment while 67% reported constraints in payment for healthcare services after suspension of the program. In the absence of insurance, the most common coping mechanisms for healthcare payment were personal savings (63.3%), donations from friends and families (34.7%) and loans (11.8%). Being a male enrollee (odd ratio=1.61), living in a rural community (odd ratio =1.77), exclusive usage of Kwara Community Health Insurance Programme (KCHIP) prior to suspension (odd ratio=1.94) and suffering an acute illness (odd ratio=3.38) increased the odds of being financially constrained in accessing healthcare. CONCLUSION: after the suspension of the scheme, many enrollees and health facilities experienced financial constraints. These underscore the importance of sustainable health insurance schemes as a risk-pooling mechanism to sustain access to good quality health care and financial protection from catastrophic health expenditures.

Beyond viral suppression: Quality of life among stable ART clients in a differentiated service delivery intervention in Tanzania.

BACKGROUND: With antiretroviral therapy, more people living with HIV (PLHIV) in resource-limited settings are virally suppressed and living longer. WHO recommends differentiated service delivery (DSD) as an alternative, less resource-demanding way of expanding HIV services access. Monitoring client's health-related quality of life (HRQoL) is necessary to understand patients' perceptions of treatment and services but is understudied in sub-Saharan Africa. We assessed HRQoL among ART clients in Tanzania accessing two service models. METHODS: Cross-sectional survey from May-August 2019 among stable ART clients randomly sampled from clinics and clubs in the Shinyanga region providing DSD and clinic-based care. HRQoL data were collected using a validated HIV-specific instrument-Functional Assessment of HIV infection (FAHI), in addition to socio-demographic, HIV care, and service accessibility data. Descriptive analysis of HRQoL, logistic regression and a stepwise multiple linear regression were performed to examine HRQoL determinants. RESULTS: 629 participants were enrolled, of which 40% accessed DSD. Similar HRQoL scores [mean (SD), p-value]; FAHI total [152.2 (22.2) vs 153.8 (20.6), p 0.687] were observed among DSD and clinic-based care participants. Accessibility factors contributed more to emotional wellbeing among DSD participants compared to the clinic-based care participants (53.4% vs 18.5%, p = < 0.001). Satisfactory (> 80% of maximum score) HRQoL scoring was associated with (OR [95% CI], p-value) being male (2.59 [1.36-4.92], p 0.004) among clinic participants and with urban residence (4.72 [1.70-13.1], p 0.001) among DSD participants. CONCLUSIONS: Similar HRQoL was observed in DSD and clinic-based care. Our research highlights focus areas to identify supporting interventions, ultimately optimizing HRQoL among PLHIV.

Determinants and perception of health insurance participation among healthcare providers in Nigeria: A mixed-methods study.

BACKGROUND: To accelerate universal health coverage, Nigeria's National Health Insurance Scheme (NHIS) decentralized the implementation of government health insurance to the individual states in 2014. Lagos is one of the states that passed a State Health Insurance Scheme into law, in order to expand the benefits of health insurance beyond the few residents enrolled in community-based health insurance programs, commercial private health insurance plans or the NHIS. Public and private healthcare providers are a critical component of the Lagos State Health Scheme (LSHS) rollout. This study explored the determinants and perception of provider participation in health insurance programs including the LSHS. METHODS: This study used a mixed-methods cross sectional design. Quantitative data were collected from 60 healthcare facilities representatively sampled from 6 Local Government Areas in Lagos state. For the qualitative data, providers were interviewed using structured questionnaires on selected characteristics of each health facility in addition to the managers' opinions about the challenges and benefits of insurance participation, capacity pressure, resource availability and financial management consequences. RESULTS: A higher proportion of provider facilities participating in insurance relative to non-participating facilities were larger with mid to (very) high patient volume, workforce, and longer years of operation. In addition, a greater proportion of private facilities compared to public facilities participated in insurance. Furthermore, a higher proportion of secondary and tertiary facilities relative to primary facilities participated in insurance. Lastly, increase in patient volume and revenue were motivating factors for provider facilities to participate in insurance, while low tariffs, delay and denial of payments, and patients' unrealistic expectations were mentioned as inhibiting factors. CONCLUSION: For the Lagos state and other government insurance schemes in developing countries to be successful, effective contracting and quality assurance of healthcare providers are essential. The health facilities indicated that these would require adequate and regular provider payment, investments in infrastructure upgrades and educating the public about insurance benefit plans and service expectations.

Clinical features and risk factors associated with morbidity and mortality among patients with COVID-19 in northern Ethiopia.

OBJECTIVE: To describe the clinical features and assess the determinants of severity and in-hospital mortality of patients with coronavirus disease 2019 (COVID-19) from a unique setting in Ethiopia. METHODS: Consecutive patients admitted to a COVID-19 isolation and treatment centre were included in this study. The overall clinical spectrum of COVID-19, and factors associated with risk of severe COVID-19 and in-hospital mortality were analysed. RESULTS: Of 2617 quarantined patients, three-quarters (n = 1935, 74%) were asymptomatic and only 114 (4.4%) presented with severe COVID-19. Common characteristics among the 682 symptomatic patients were cough (n = 354, 50.6%), myalgia (n = 212, 31.1%), headache (n = 196, 28.7%), fever (n = 161, 23.6%), dyspnoea (n = 111, 16.3%), anosmia and/or dysgeusia (n = 90, 13.2%), sore throat (n = 87, 12.8%) and chest pain (n = 77, 11.3%). Factors associated with severe COVID-19 were older age [adjusted relative risk (aRR) 1.78, 95% confidence interval (CI) 1.61-1.97; P < 0.0001], diabetes (aRR 2.00, 95% CI 1.20-3.32; P = 0.007), cardiovascular disease (aRR 2.53, 95% CI 1.53-4.17; P < 0.0001), malignancy (aRR 4.57, 95% CI 1.62-12.87; P = 0.004), surgery/trauma (aRR 23.98, 95% CI 10.35-55.57; P < 0.0001) and human immunodeficiency virus infection (aRR 4.24, 95% CI 1.55-11.61; P = 005). Factors associated with risk of in-hospital mortality included older age (aRR 2.37, 95% CI 1.90-2.95; P < 0.001), malignancy (aRR 6.73, 95% CI 1.50-30.16; P = 0.013) and surgery/trauma (aRR 59.52, 95% CI 12.90-274.68; P < 0.0001). CONCLUSIONS: A significant proportion of cases of COVID-19 were asymptomatic, and key comorbid conditions increased the risk of severe COVID-19 and in-hospital mortality. These findings could help in the design of appropriate management strategies for patients.

SafeCare: An Innovative Approach for Improving Quality Through Standards, Benchmarking, and Improvement in Low- and Middle- Income Countries.

BACKGROUND: In low- and middle-income countries (LMICs), patients often have limited access to high-quality care because of a shortage of facilities and human resources, inefficiency of resource allocation, and limited health insurance. SafeCare was developed to provide innovative health care standards; surveyor training; a grading system for quality of care; a quality improvement process that is broken down into achievable, measurable steps to facilitate incremental improvement; and a private sector-supported health financing model. METHODS: Three organizations-PharmAccess Foundation, Joint Commission International, and the Council for Health Service Accreditation of Southern Africa-launched SafeCare in 2011 as a formal partnership. Five SafeCare levels of improvement are allocated on the basis of an algorithm that incorporates both the overall score and weighted criteria, so that certain high-risk criteria need to be in place before a facility can move to the next SafeCare certification level. A customized quality improvement plan based on the SafeCare assessment results lists the specific, measurable activities that should be undertaken to address gaps in quality found during the initial assessment and to meet the nextlevel SafeCare certificate. RESULTS: The standards have been implemented in more than 800 primary and secondary facilities by qualified local surveyors, in partnership with various local public and private partner organizations, in six sub-Saharan African countries (Ghana, Kenya, Nigeria, Namibia, Tanzania, and Zambia). CONCLUSION: Expanding access to care and improving health care quality in LMICs will require a coordinated effort between institutions and other stakeholders. SafeCare's standards and assessment methodology can help build trust between stakeholders and lay the foundation for country-led quality monitoring systems.

Stability of HIV-1 Nucleic Acids in Dried Blood Spot Samples for HIV-1 Drug Resistance Genotyping.

Dried blood spots (DBS) are an easy to collect sample-type that can stabilize biological material at ambient temperature for transport and storage, making them ideal for use in resource-limited settings (RLS). We investigated the effect of storage temperature and duration on ability to detect mixed HIV-1 viral RNA populations, and subsequently viral RNA populations in a background of proviral DNA. Part one of the study used DBS samples of whole blood spiked with specific quantities of HIV-1 subtype-B and -C RNA to study mixed virus population detection. Part two used DBS comprising of HIV-1 subtype-B proviral DNA containing U1 cells combined with HIV-1 subtype-C RNA to mimic HIV-1 infected clinical samples as a model system to study the relative stability of HIV-1 RNA and DNA in DBS. Prepared DBS were stored at -20 °C and +30 °C for periods of one day, one, two, and four weeks. Samples were genotyped to determine changes in the detection of mixtures in the sample over time. From two weeks onwards, storage at +30 °C resulted in gradual, time-related reduction in the detection of mixed virus population at log10 VL 4.0 but not at log10 5.0. Proviral DNA and viral RNA were both stable for at least 52 weeks when stored at -20 °C, compared to progressive RNA decay over time at +30 °C. DBS storage conditions and duration had a significant effect on HIV-1 RNA amplification. Our results demonstrate that DBS storage at ambient temperature (+30 °C) should not exceed two weeks, with long-term storage at -20 °C or lower.

Do prevailing theories sufficiently explain perceptions and health-seeking behavior of Ghanaians?

The challenges faced by African countries that have pioneered a national health insurance scheme (NHIS) and the lessons learned can be of great value to other countries, contemplating the introduction of such a health financing system. In 2003, Ghana initiated the NHIS to provide access to healthcare for people in both the formal and informal sectors. The paper assesses the applicability of four theoretical models to explain the perceptions and decisions of Ghanaians to participate in the NHIS. To contextualize these models, we used qualitative data from individual and group interviews of Ghanaians. These interviews form part of the study "towards a client-oriented health insurance system in Ghana" to explain the uptake of the Ghanaian social health insurance. The paper argues for a new integrated model to provide a better understanding of clients' perceptions on illness, healthcare and health insurance. Such a model should highlight trust as a fundamental factor influencing the decision of Ghanaians to enroll in the NHIS.

HIV-1 phenotypic reverse transcriptase inhibitor drug resistance test interpretation is not dependent on the subtype of the virus backbone.

To date, the majority of HIV-1 phenotypic resistance testing has been performed with subtype B virus backbones (e.g. HXB2). However, the relevance of using this backbone to determine resistance in non-subtype B HIV-1 viruses still needs to be assessed. From 114 HIV-1 subtype C clinical samples (36 ARV-naïve, 78 ARV-exposed), pol amplicons were produced and analyzed for phenotypic resistance using both a subtype B- and C-backbone in which the pol fragment was deleted. Phenotypic resistance was assessed in resulting recombinant virus stocks (RVS) for a series of antiretroviral drugs (ARV's) and expressed as fold change (FC), yielding 1660 FC comparisons. These Antivirogram® derived FC values were categorized as having resistant or sensitive susceptibility based on biological cut-off values (BCOs). The concordance between resistance calls obtained for the same clinical sample but derived from two different backbones (i.e. B and C) accounted for 86.1% (1429/1660) of the FC comparisons. However, when taking the assay variability into account, 95.8% (1590/1660) of the phenotypic data could be considered as being concordant with respect to their resistance call. No difference in the capacity to detect resistance associated with M184V, K103N and V106M mutations was noted between the two backbones. The following was concluded: (i) A high level of concordance was shown between the two backbone phenotypic resistance profiles; (ii) Assay variability is largely responsible for discordant results (i.e. for FC values close to BCO); (iii) Confidence intervals should be given around the BCO's, when assessing resistance in HIV-1 subtype C; (iv) No systematic resistance under- or overcalling of subtype C amplicons in the B-backbone was observed; (v) Virus backbone subtype sequence variability outside the pol region does not contribute to phenotypic FC values. In conclusion the HXB2 virus backbone remains an acceptable vector for phenotyping HIV-1 subtype C pol amplicons.

Timing of blood sampling for CD4 T-cell counting influences HAART decisions.

BACKGROUND: Variability in CD4 T-cell counts has been described for both healthy and HIV-infected persons. It may influence decisions with respect to initiation and monitoring of antiretroviral treatment. OBJECTIVE: to measure the effect of timing of blood sampling for blood cell count measurement. METHOD: The study population consisted of 71 Ethiopian patients in an observational cohort, either being monitored prior to HAART (n = 40) or receiving HAART (n = 31) at an ART Clinic in Addis Ababa. RESULT: The median CD4 count demonstrated significantly increasing trends from the morning (8 am) to the afternoon (4 pm), both for patients on HAART (increase of 137 CD4 cell/microl; p = 0.003) and for patients initiating HAART (increase of 56 CD4 cells/microl; p = 0.038). This trend was also observed for CD8+ and CD3+ T-lymphocytes, (initiating HAART p = 0.002 and p = 0.001; patients on HAART p = 0.015 and p = 0.004, respectively). CONCLUSION: The implications of these findings are for the decision to start HAART or the decision to start prevention of opportunistic infections in Ethiopian patients on HAART.

Anonymous HIV workplace surveys as an advocacy tool for affordable private health insurance in Namibia.

BACKGROUND: With an estimated adult HIV prevalence of 15%, Namibia is in need of innovative health financing strategies that can alleviate the burden on the public sector. Affordable and private health insurances were recently developed in Namibia, and they include coverage for HIV/AIDS. This article reports on the efficacy of HIV workplace surveys as a tool to increase uptake of these insurances by employees in the Namibian formal business sector. In addition, the burden of HIV among this population was examined by sector. METHODS: Cross-sectional anonymous HIV prevalence surveys were conducted in 24 private companies in Namibia between November 2006 and December 2007. Non-invasive oral fluid-based HIV antibody rapid tests were used. Anonymous test results were provided to the companies in a confidential report and through presentations to their management, during which the advantages of affordable private health insurance and the available insurance products were discussed. Impact assessment was conducted in October 2008, when new health insurance uptake by these companies was evaluated. RESULTS: Of 8500 targeted employees, 6521 were screened for HIV; mean participation rate was 78.6%. Overall 15.0% (95% CI 14.2-15.9%) of employees tested HIV positive (range 3.0-23.9% across companies). The mining sector had the highest percentage of HIV-positive employees (21.0%); the information technology (IT) sector had the lowest percentage (4.0%). Out of 6205 previously uninsured employees, 61% had enrolled in private health insurance by October 2008. The majority of these new insurances (78%) covered HIV/AIDS only. CONCLUSION: The proportion of HIV-positive formal sector employees in Namibia is in line with national prevalence estimates and varies widely by employment sector. Following the surveys, there was a considerable increase in private health insurance uptake. This suggests that anonymous HIV workplace surveys can serve as a tool to motivate private companies to provide health insurance to their workforce. Health insurance taken up by those who are able to pay the fees will alleviate the burden on the public sector.