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Teklay Gebrecherkos,1 Feyissa Challa,2 Geremew Tasew,3 Zekarias Gessesse,4 Yazezew Kiros,4 Atsbeha Gebreegziabxier,5 Mahmud Abdulkader,1 Abraham Aregay Desta,6 Ataklti Hailu Atsbaha,7 Getachew Tollera,8 Saro Abrahim,5 Britta C Urban,9 Henk Schallig,10 Tobias Rinke de Wit,11,12 Dawit Wolday1,5 1Department of Medical Microbiology and Immunology, College of Health Sciences (CHS), Mekelle University (MU), Mekelle, Tigray, Ethiopia; 2National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 3Department of Bacteriology, Parasitology and Zoonosis, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 4Department of Internal Medicine, College of Health Sciences, Mekelle University, Mekelle, Tigray, Ethiopia; 5HIV/TB Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 6Public Health Research and Emergency Management, Tigray Health Research Institute, Mekelle, Tigray, Ethiopia; 7Department of Microbiology, Tigray Health Research Institute, Mekelle, Tigray, Ethiopia; 8Research and Technology Transfer Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 9Department of Clinical Sciences, Respiratory Clinical Research Group, Liverpool School of Tropical Medicine, Liverpool, UK; 10Department of Medical Microbiology and Infection Prevention, Experimental Parasitology Unit, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; 11Amsterdam Institute of Global Health and Development, Department of Global Health, Amsterdam University Medical Center, Amsterdam, the Netherlands; 12Joep-Lange Institute, Amsterdam, the NetherlandsCorrespondence: Teklay Gebrecherkos, Department of Medical Microbiology and Immunology, Mekelle University, P.O. Box 1871, Mekelle, Tigray, Ethiopia, Email estiftg17@gmail.comPurpose: To evaluate the role of C-reactive protein (CRP) in predicting severe COVID-19 patients.Methods: A prospective observational cohort study was conducted from July 15 to October 28, 2020, at Kuyha COVID-19 isolation and treatment center hospital, Mekelle City, Northern Ethiopia. A total of 670 blood samples were collected serially. SARS-CoV-2 infection was confirmed by RT-PCR from nasopharyngeal swabs and CRP concentration was determined using Cobas Integra 400 Plus (Roche). Data were analyzed using STATA version 14. P-value < 0.05 was considered statistically significant.Results: Overall, COVID-19 patients had significantly elevated CRP at baseline when compared to PCR-negative controls [median 11.1 (IQR: 2.0– 127.8) mg/L vs 0.9 (IQR: 0.5– 1.9) mg/L; p=0.0004)]. Those with severe COVID-19 clinical presentation had significantly higher median CRP levels compared to those with non-severe cases [166.1 (IQR: 48.6– 332.5) mg/L vs 2.4 (IQR: 1.2– 7.6) mg/L; p< 0.00001)]. Moreover, COVID-19 patients exhibited higher median CRP levels at baseline [58 (IQR: 2.0– 127.8) mg/L] that decreased significantly to 2.4 (IQR: 1.4– 3.9) mg/L after 40 days after symptom onset (p< 0.0001). Performance of CRP levels determined using ROC analysis distinguished severe from non-severe COVID-19 patients, with an AUC value of 0.83 (95% CI: 0.73– 0.91; p=0.001; 77.4% sensitivity and 89.4% specificity). In multivariable analysis, CRP levels above 30 mg/L were significantly associated with an increased risk of developing severe COVID-19 for those who have higher ages and comorbidities (ARR 3.99, 95% CI: 1.35– 11.82; p=0.013).Conclusion: CRP was found to be an independent determinant factor for severe COVID-19 patients. Therefore, CRP levels in COVID-19 patients in African settings may provide a simple, prompt, and inexpensive assessment of the severity status at baseline and monitoring of treatment outcomes.Keywords: CRP, COVID-19, SARS-CoV-2, biomarker

Introduction: Limited access to health care in rural areas is a challenge in Namibia. In 2007 a survey was conducted among employers of commercial farms to assess the feasibility of introducing private, affordable health insurance that including HIV/AIDS coverage for commercial farm workers in Namibia. Healthcare access and utilization by people living and working on commercial farms were evaluated to gain insight into the possibility to strengthen health service delivery in this sector. Method: A cross-sectional survey of all members of the Agricultural Employers' Association was conducted by telephone interview in a one-year period from 2006. The population sampled included 1708 employers in farms throughout 8 regions of Namibia. Results: In total, 1402 farm employers (82%) agreed to participate, representing 1414 farms and an average of 10.2 employees (range 0-342; 95% CI: 9.50, 10.94) per farm. Employers surveyed reported 95% of farms (95%CI: 93.6, 95.9) had access to at least one medical facility. Employers on the majority of farms (94.7%; 95%CI: 93.6, 95.9) reported that employees had visited at least one medical facility, most frequently using clinics (79.2%, 95%CI: 77.09, 81.32), doctors (50.1%; 95%CI: 47.53, 52.74) and mobile clinics (45.7%; 95%CI: 43.10, 48.28). Employers were significantly more likely to use private doctors (x2=616.2, df=1, p<0.0003), travel longer distances (t=-11.34, df=1,470.5, p<0.0003) to reach them, and more likely to have health insurance coverage than employees (x2=1,098, df=1, p<0.0003). Employers on several farms reported covering costs for health-related transport (92.1%; 95%CI: 90.7, 93.5), medical consultations (62.2%; 95%CI: 59.7, 64.8), and providing free medications (88%; 95%CI: 86.2, 89.7). Only 0.85% of farms (95%CI: 0.37, 1.33) reported having employees enrolled in health insurance, but 77.1% (95%CI: 74.6, 79.4) of employers not providing insurance said they were willing to share costs for health insurance for employees. In addition, 148 farms had persons with formal medical training on site. Conclusions: Employees on commercial farms in Namibia and their dependants do not have adequate access to formal health care and in particular to HIV/AIDS-related services. Access could be improved by strengthening and expanding the on-site health services provided by some farmers, including basic care and support for on-site health professionals. While few employees were covered by health insurance, employers expressed great willingness to co-pay for a basic plan that would include outpatient care. [ABSTRACT FROM AUTHOR]

Sixty-three overlapping 15-oligomer peptides covering the 30-kDa protein antigen 85B of Mycobacterium leprae were tested by ELISA to identify epitopes recognized by human antibodies. Serum samples from patients with lepromatous leprosy (LL) reacted mainly with peptides comprising amino acid regions (AA) 206–230, 251–280, and 291–325. Sera of patients with active tuberculosis who responded to the native 30-kDa antigen did not recognize these peptides. The antibody-binding specificity to the defined B cell regions was evaluated in a blind study with 71 serum samples from patients and household contacts living in Ethiopia where leprosy is endemic. The peptide of AA 256–280 was recognized by 88% of LL patients, 15% of patients with tuberculoid leprosy, and none of the contacts. These findings suggest that there are major linear B cell epitopes on the M. leprae 30-kDa protein that are recognized by lepromin-negative LL patients, whereas lepromin-positive patients respond preferentially to conformational epitopes. [ABSTRACT FROM PUBLISHER]

Abstract Background As countries in sub-Saharan Africa develop their economies, it is important to understand the health of employees and its impact on productivity and absenteeism. While previous studies have assessed the impact of single conditions on absenteeism, the current study evaluates multiple health factors associated with absenteeism in a large worker population across several sectors in Namibia. Methods From March 2009 to June 2010, PharmAccess Namibia conducted a series of cross-sectional surveys of 7,666 employees in 7 sectors of industry in Namibia. These included a self-reported health questionnaire and biomedical screenings for certain infectious diseases and non-communicable disease (NCD) risk factors. Data were collected on demographics, absenteeism over a 90-day period, smoking behavior, alcohol use, hemoglobin, blood pressure, blood glucose, cholesterol, waist circumference, body mass index (BMI), HIV status, and presence of hepatitis B antigens and syphilis antibodies. The associations of these factors to absenteeism were ascertained using negative binomial regression. Results Controlling for demographic and job-related factors, high blood glucose and diabetes had the largest effect on absenteeism (IRR: 3.67, 95%CI: 2.06-6.55). This was followed by anemia (IRR: 1.59, 95%CI: 1.17-2.18) and being HIV positive (IRR: 1.47; 95%CI: 1.12-1.95). In addition, working in the fishing or services sectors was associated with an increased incidence of sick days (IRR: 1.53, 95%CI: 1.23-1.90; and IRR: 1.70, 95%CI: 1.32-2.20 respectively). The highest prevalence of diabetes was in the services sector (3.6%, 95%CI:-2.5-4.7). The highest prevalence of HIV was found in the fishing sector (14.3%, 95%CI: 10.1-18.5). Conclusion Both NCD risk factors and infectious diseases are associated with increased rates of short-term absenteeism of formal sector employees in Namibia. Programs to manage these conditions could help employers avoid costs associated with absenteeism. These programs could include basic health care insurance including regular wellness screenings.

Abstract Background As second-line antiretroviral treatment (ART) becomes more accessible in resource-limited settings (RLS), the need for more affordable monitoring tools such as point-of-care viral load assays and simplified genotypic HIV drug resistance (HIVDR) tests increases substantially. The prohibitive expenses of genotypic HIVDR assays could partly be addressed by focusing on a smaller region of the HIV reverse transcriptase gene (RT) that encompasses the majority of HIVDR mutations for people on ART in RLS. In this study, an in silico analysis of 125,329 RT sequences was performed to investigate the effect of submitting short RT sequences (codon 41 to 238) to the commonly used virco®TYPE and Stanford genotype interpretation tools. Results Pair-wise comparisons between full-length and short RT sequences were performed. Additionally, a non-inferiority approach with a concordance limit of 95% and two-sided 95% confidence intervals was used to demonstrate concordance between HIVDR calls based on full-length and short RT sequences. The results of this analysis showed that HIVDR interpretations based on full-length versus short RT sequences, using the Stanford algorithms, had concordance significantly above 95%. When using the virco®TYPE algorithm, similar concordance was demonstrated (>95%), but some differences were observed for d4T, AZT and TDF, where predictions were affected in more than 5% of the sequences. Most differences in interpretation, however, were due to shifts from fully susceptible to reduced susceptibility (d4T) or from reduced response to minimal response (AZT, TDF) or vice versa, as compared to the predicted full RT sequence. The virco®TYPE prediction uses many more mutations outside the RT 41-238 amino acid domain, which significantly contribute to the HIVDR prediction for these 3 antiretroviral agents. Conclusions This study illustrates the acceptability of using a shortened RT sequences (codon 41-238) to obtain reliable genotype interpretations by virco®TYPE and Stanford algorithms. Implementation of this simplified protocol could significantly reduce the cost of both resistance testing and ARV treatment monitoring in RLS.

Problem A multinational company with operations in several African countries was committed to offer antiretroviral treatment to its employees and their dependants. Approach The Accelerating Access Initiative (AAI), an initiative of six pharmaceutical companies and five United Nations' agencies, offered the possibility of obtaining brand antiretroviral drugs (ARVs) at 10% of the commercial price. PharmAccess, a foundation aimed at removing barriers to AIDS treatment in Africa, helped to establish an HIV policy and treatment guidelines, and a workplace programme was rolled out from September 2001. Local setting Private sector employers in Africa are keen to take more responsibility in HIV prevention and AIDS care. An important hurdle for African employers remains the price and availability of ARVs. Relevant changes The programme encountered various hurdles, among them the need for multiple contracts with multiple companies, complex importation procedures, taxes levied on ARVs, lack of support from pharmaceutical companies in importation and transportation, slow delivery of the drugs, lack of institutional memory in pharmaceutical companies and government policies excluding the company from access to ARVs under the AAI. Lessons learned The launch of the AAI enabled this multinational company to offer access to ARVs to its employees and dependants. The private sector should have access to these discounted drugs under the AAI. A network of local AAI offices should be created to assist in logistics of drugs ordering, purchase and clearance. No taxes should be levied on ARVs. [ABSTRACT FROM AUTHOR]

Background: People living with HIV (PLHIV) have to take lifelong antiretroviral treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally, mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors unique to this demographic group. The use of digital health interventions, such as real-time medication monitor (RTMM)-based digital adherence tools (DATs), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to reduced HIV-associated morbidity and mortality., Aim: To provide the evidence base for a digital adherence intervention to improve treatment outcomes in YPLHIV on ART., Objectives: 1. The primary objective is to determine the efficacy of a customised DAT compared to the standard of care in improving ART adherence in YPLHIV. 2. The secondary objective is to determine the efficacy of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV., Methodology: This will be a parallel open-label randomised control controlled two-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is the proportion adherent at 9 months (> = 95% by pill count), and the secondary outcome is the proportion with viral load suppressed at 9 months (< 200 copies/ml)., Discussion: There is a paucity of good quality evidence on effective digital health interventions to improve ART adherence and viral load suppression in YPLHIV globally and particularly in HIV high-burden settings like Malawi. This study will provide good-quality evidence on the effectiveness of a customised DAT in improving ART adherence and viral load suppression in this important demographic., Trial Registration: The trial has been registered in the Pan African Clinical Trials Registry number: PACTR202303867267716 on 23 March 2023 and can be accessed through the following URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424 . All items from the WHO Trial Registration Data Set are described in this manuscript., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Maternal and neonatal mortality rates in many low- and middle-income countries (LMICs) are still far above the targets of the United Nations Sustainable Development Goal 3. Value-based healthcare (VBHC) has the potential to outperform traditional supply-driven approaches in changing this dismal situation, and significantly improve maternal, neonatal and child health (MNCH) outcomes. We developed a theory of change and used a cohort-based implementation approach to create short and long learning cycles along which different components of the VBHC framework were introduced and evaluated in Kenya. At the core of the approach was a value-based care bundle for maternity care, with predefined cost and quality of care using WHO guidelines and adjusted to the risk profile of the pregnancy. The care bundle was implemented using a digital exchange platform that connects pregnant women, clinics and payers. The platform manages financial transactions, enables bi-directional communication with pregnant women via SMS, collects data from clinics and shares enriched information via dashboards with payers and clinics. While the evaluation of health outcomes is ongoing, first results show improved adherence to evidence-based care pathways at a predictable cost per enrolled person. This community case study shows that implementation of the VBHC framework in an LMIC setting is possible for MNCH. The incremental, cohort-based approach enabled iterative learning processes. This can support the restructuring of health systems in low resource settings from an output-driven model to a value based financing-driven model., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Dohmen, De Sanctis, Waiyaiya, Janssens, Rinke de Wit, Spieker, Van der Graaf and Van Raaij.)

Competing Interests: Competing interests: A-MV declares consultancy fees from Gilead.

Background: Differentiated service delivery (DSD) offers benefits to people living with HIV (improved access, peer support), and the health system (clinic decongestion, efficient service delivery). ART clubs, 15-30 clients who usually meet within the community, are one of the most common DSD options. However, evidence about the quality of care (QoC) delivered in ART clubs is still limited., Materials and Methods: We conducted a concurrent triangulation mixed-methods study as part of the Test & Treat project in northwest Tanzania. We surveyed QoC among stable clients and health care workers (HCW) comparing between clinics and clubs. Using a Donabedian framework we structured the analysis into three levels of assessment: structure (staff, equipment, supplies, venue), processes (time-spent, screenings, information, HCW-attitude), and outcomes (viral load, CD4 count, retention, self-worth)., Results: We surveyed 629 clients (40% in club) and conducted eight focus group discussions, while 24 HCW (25% in club) were surveyed and 22 individual interviews were conducted. Quantitative results revealed that in terms of structure, clubs fared better than clinics except for perceived adequacy of service delivery venue (94.4% vs 50.0%, p = 0.013). For processes, time spent receiving care was significantly more in clinics than clubs (119.9 vs 49.9 minutes). Regarding outcomes, retention was higher in the clubs (97.6% vs 100%), while the proportion of clients with recent viral load <50 copies/ml was higher in clinics (100% vs 94.4%). Qualitative results indicated that quality care was perceived similarly among clients in clinics and clubs but for different reasons. Clinics were generally perceived as places with expertise and clubs as efficient places with peer support and empathy. In describing QoC, HCW emphasized structure-related attributes while clients focused on processes. Outcomes-related themes such as improved client health status, self-worth, and confidentiality were similarly perceived across clients and HCW., Conclusion: We found better structure and process of care in clubs than clinics with comparable outcomes. While QoC was perceived similarly in clinics and clubs, its meaning was understood differently between clients. DSD catered to the individual needs of clients, either technical care in the clinic or proximate and social care in the club. Our findings highlight that both clinic and DSD care are required as many elements of QoC were individually perceived., Competing Interests: The Shinyanga and Simiyu Test & Treat program in Tanzania is funded by Gilead Sciences (USA). This does not alter our adherence to PLOS ONE policies on sharing data and materials. [GBG is currently employed by Sanofi Pasteur. Sanofi Pasteur was not involved in any way and did not provide funding for this study]. All other authors declare that they have no competing interests.

Objective: This study examined people's motivations for (repeatedly) utilizing HIV testing services during community-based testing events in urban and rural Shinyanga, Tanzania and potential implications for Universal Health Coverage (UHC)., Methods: As part of a broader multidisciplinary study on the implementation of a HIV Test and Treat model in Shinyanga Region, Tanzania, this ethnographic study focused on community-based testing campaigns organised by the implementing partner. Between April 2018 and December 2019, we conducted structured observations (24), short questionnaires (42) and in-depth interviews with HIV-positive (23) and HIV-negative clients (8). Observations focused on motivations for (re-)testing, and the counselling and testing process. Thematic analysis based on inductive and deductive coding was completed using NVivo software., Results: Regular HIV testing was encouraged by counsellors. Most participants in testing campaigns were HIV-negative; 51.1% had tested more than once over their lifetimes. Testing campaigns provided an accessible way to learn one's HIV status. Motivations for repeat testing included: monitoring personal health to achieve (temporary) reassurance, having low levels of trust toward sexual partners, feeling at risk, seeking proof of (ill)-health, and acting responsibly. Repeat testers also associated testing with a desire to start treatment early to preserve a healthy-looking body, should they prove HIV positive., Conclusions: Community-based testing campaigns serve three valuable functions related to HIV prevention and treatment: 1) enable community members to check their HIV status regularly as part of a personalized prevention strategy that reinforces responsible behaviour; 2) identify recently sero-converted clients who would not otherwise be targeted; and 3) engage community with general prevention and care messaging and services. This model could be expanded to include routine management of other (chronic) diseases and provide an entry for scaling up UHC., Competing Interests: The Shinyanga and Simiyu Test & Treat program in Tanzania is funded by Gilead Sciences (USA), contract date June 1st 2016. The Amsterdam Institute for Global Health and Development (AIGHD) is a co-recipient of this award. All authors were employed under AIGHD’s auspices. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The funders did not play an active role in study design, data collection, analysis, decision to publish or preparation of the manuscript. All authors declare not to have competing interests.

Poor access to HIV viral load (VL) testing prevents the timely monitoring of HIV treatment adherence and efficacy. Factors enabling clinical benefits of VL testing when added to local standards of care, can inform the development of more cost-effective routine VL scale-up plans. We compared antiretroviral therapy (ART) switch practices in 13 clinics across 6 countries, with full ( N  = 8), phasing-in ( N  = 3) or no onsite access ( N  = 2) to VL. The analysis used data from the Pan-African Studies to Evaluate Resistance (PASER), observing virological and drug resistance outcomes among adults receiving first- or second-line ART between 2008 and 2015. Study plasma viral load (sVL) determined at baseline, every 12 months thereafter and at the time of switch served for retrospectively validating switch decisions, categorized into "necessary," "unnecessary," and "missed." Virological failure was defined as two consecutive sVL ≥1,000 HIV-RNA copies/mL. One thousand nine hundred ninety-five of the 2,420 (82.4%) study participants had continuous virological suppression during the median 30 months of follow-up. Among the 266 virological failures (11.0%), the proportion of necessary switches were similar in clinics with full (37%), phasing-in (25%), or no access (39%) to local VL testing. Documented utilization of local VL results for the switch decision was associated with higher percentage of necessary switch (87.6% vs. 67.9%). Shorter time to necessary switch was associated with higher rates of long-term virological suppression, regardless of access to local viral load. Availability of HIV VL testing capacity does not systematically result in adequate switch practices or better virological outcomes. Systems supporting sufficient test demand execution, and actual utilization of results for patient management need strengthening.

Background: There is concern over increasing prevalence of non-nucleoside reverse-transcriptase inhibitor (NNRTI) resistance in people initiating antiretroviral therapy (ART) in low-income and middle-income countries. We assessed the effectiveness and cost-effectiveness of alternative public health responses in countries in sub-Saharan Africa where the prevalence of pretreatment drug resistance to NNRTIs is high., Methods: The HIV Synthesis Model is an individual-based simulation model of sexual HIV transmission, progression, and the effect of ART in adults, which is based on extensive published data sources and considers specific drugs and resistance mutations. We used this model to generate multiple setting scenarios mimicking those in sub-Saharan Africa and considered the prevalence of pretreatment NNRTI drug resistance in 2017. We then compared effectiveness and cost-effectiveness of alternative policy options. We took a 20 year time horizon, used a cost effectiveness threshold of US$500 per DALY averted, and discounted DALYs and costs at 3% per year., Findings: A transition to use of a dolutegravir as a first-line regimen in all new ART initiators is the option predicted to produce the most health benefits, resulting in a reduction of about 1 death per year per 100 people on ART over the next 20 years in a situation in which more than 10% of ART initiators have NNRTI resistance. The negative effect on population health of postponing the transition to dolutegravir increases substantially with higher prevalence of HIV drug resistance to NNRTI in ART initiators. Because of the reduced risk of resistance acquisition with dolutegravir-based regimens and reduced use of expensive second-line boosted protease inhibitor regimens, this policy option is also predicted to lead to a reduction of overall programme cost., Interpretation: A future transition from first-line regimens containing efavirenz to regimens containing dolutegravir formulations in adult ART initiators is predicted to be effective and cost-effective in low-income settings in sub-Saharan Africa at any prevalence of pre-ART NNRTI resistance. The urgency of the transition will depend largely on the country-specific prevalence of NNRTI resistance., Funding: Bill & Melinda Gates Foundation, World Health Organization., (Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY IGO 3.0 licence. Published by Elsevier Ltd.. All rights reserved.)

We evaluated a low-cost virological failure assay (VFA) on plasma and dried blood spot (DBS) specimens from HIV-1 infected patients attending an HIV clinic in Harare. The results were compared to the performance of the ultrasensitive heat-denatured p24 assay (p24). The COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, served as the gold standard. Using a cutoff of 5,000 copies/mL, the plasma VFA had a sensitivity of 94.5% and specificity of 92.7% and was largely superior to the VFA on DBS (sensitivity = 61.9%; specificity = 99.0%) or to the p24 (sensitivity = 54.3%; specificity = 82.3%) when tested on 302 HIV treated and untreated patients. However, among the 202 long-term ART-exposed patients, the sensitivity of the VFA decreased to 72.7% and to 35.7% using a threshold of 5,000 and 1,000 RNA copies/mL, respectively. We show that the VFA (either on plasma or on DBS) and the p24 are not reliable to monitor long-term treated, HIV-1 infected patients. Moreover, achieving acceptable assay sensitivity using DBS proved technically difficult in a less-experienced laboratory. Importantly, the high level of virological suppression (93%) indicated that quality care focused on treatment adherence limits virological failure even when PCR-based viral load monitoring is not available.

Background: Access to antiretroviral treatment in resource-limited-settings is inevitably paralleled by the emergence of HIV drug resistance. Monitoring treatment efficacy and HIV drugs resistance testing are therefore of increasing importance in resource-limited settings. Yet low-cost technologies and procedures suited to the particular context and constraints of such settings are still lacking. The ART-A (Affordable Resistance Testing for Africa) consortium brought together public and private partners to address this issue., Objectives: To develop an automated sequence analysis and editing software to support high throughput automated sequencing., Study Design: The ART-A Software was designed to automatically process and edit ABI chromatograms or FASTA files from HIV-1 isolates., Results: The ART-A Software performs the basecalling, assigns quality values, aligns query sequences against a set reference, infers a consensus sequence, identifies the HIV type and subtype, translates the nucleotide sequence to amino acids and reports insertions/deletions, premature stop codons, ambiguities and mixed calls. The results can be automatically exported to Excel to identify mutations. Automated analysis was compared to manual analysis using a panel of 1624 PR-RT sequences generated in 3 different laboratories. Discrepancies between manual and automated sequence analysis were 0.69% at the nucleotide level and 0.57% at the amino acid level (668,047 AA analyzed), and discordances at major resistance mutations were recorded in 62 cases (4.83% of differences, 0.04% of all AA) for PR and 171 (6.18% of differences, 0.03% of all AA) cases for RT., Conclusions: The ART-A Software is a time-sparing tool for pre-analyzing HIV and viral quasispecies sequences in high throughput laboratories and highlighting positions requiring attention., (Copyright © 2012 Elsevier B.V. All rights reserved.)

--In recent years, implementation of antiretroviral therapy in developing countries with a high prevalence of HIV-1 has been recognised as a public health priority. Consequently, the availability ofantiretroviral combination therapy for people with HIV is increasing rapidly in sub-Saharan Africa. --HIV treatment programmes are implemented according to the standardised, simplified public health guidelines developed by the World Health Organization (WHO). --However, the implementation of treatment programmes in Africa is hindered by several factors, including the lack of adequate immunological and virological laboratory monitoring, insufficient support for adherence to therapy, vulnerable health care systems and the use of suboptimal drug combinations. --These suboptimal treatment conditions increase the risk that resistant virus strains will emerge that are less susceptible to standard first-line combination therapy, thus threatening the long-term success of the treatment programmes. --The WHO has initiated HIVResNet, an international expert advisory board that has developed a global strategy for surveillance and prevention of antiretroviral drug resistance. --The Dutch initiative known as 'PharmAccess African studies to evaluate resistance' (PASER) is contributing to this strategy by creating a surveillance network in sub-Saharan Africa.