Publications by authors named "Charles Kiyaga"

33 Publications

Next generation sequencing based in-house HIV genotyping method: validation report.

AIDS Res Ther 2021 10 2;18(1):64. Epub 2021 Oct 2.

National Health Laboratories and Diagnostic Services, Central Public Health Laboratories, Ministry of Health, P.O Box 7272, Kampala, Uganda.

Background: HIV genotyping has had a significant impact on the care and treatment of HIV/AIDS. At a clinical level, the test guides physicians on the choice of treatment regimens. At the surveillance level, it informs policy on consolidated treatment guidelines and microbial resistance control strategies. Until recently, the conventional test has utilized the Sanger sequencing (SS) method. Unlike Next Generation Sequencing (NGS), SS is limited by low data throughput and the inability of detecting low abundant drug-resistant variants. NGS can improve sensitivity and quantitatively identify low-abundance variants; in addition, it has the potential to improve efficiency as well as lowering costs when samples are batched. Despite the NGS benefits, its utilization in clinical drug resistance profiling is faced with mixed reactions. These are largely based on a lack of a consensus regarding the quality control strategy. Nonetheless, transitional views suggest validating the method against the gold-standard SS. Therefore, we present a validation report of an NGS-based in-house HIV genotyping method against the SS method in Uganda.

Results: Since there were no established proficiency test panels for NGS-based HIV genotyping, 15 clinical plasma samples for routine care were utilized. The use of clinical samples allowed for accuracy and precision studies. The workflow involved four main steps; viral RNA extraction, targeted amplicon generation, amplicon sequencing and data analysis. Accuracy of 98% with an average percentage error of 3% was reported for the NGS based assay against the SS platform demonstrating similar performance. The coefficient of variation (CV) findings for both the inter-run and inter-personnel precision showed no variability (CV ≤ 0%) at the relative abundance of ≥ 20%. For both inter-run and inter-personnel, a variation that affected the precision was observed at 1% frequency. Overall, for all the frequencies, CV registered a small range of (0-2%).

Conclusion: The NGS-based in-house HIV genotyping method fulfilled the minimum requirements that support its utilization for drug resistance profiling in a clinical setting of a low-income country. For more inclusive quality control studies, well-characterized wet panels need to be established.
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http://dx.doi.org/10.1186/s12981-021-00390-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487565PMC
October 2021

Operational analysis of the national sickle cell screening programme in the Republic of Uganda.

Afr J Lab Med 2021 12;10(1):1303. Epub 2021 Aug 12.

Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.

Background: Sickle cell anaemia is a common global life-threatening haematological disorder. Most affected births occur in sub-Saharan Africa where children usually go undiagnosed and die early in life. Uganda's national sickle cell screening programme was developed in response to a 2014 sickle cell surveillance study that documented a high disease prevalence.

Objective: This study describes the temporal and financial aspects of Uganda's 2014-2019 sickle cell screening programme.

Methods: National sickle cell screening data from Uganda's Central Public Health Laboratories were used to calculate turn-around times (TATs) from sample collection to delivery, testing, and result reporting for blood samples collected from February 2014 to March 2019. The parameters affecting specific TATs were assessed. The exact programme expenditures were analysed to determine cost per test and per positive sickle cell disease case detected.

Results: A total of 278 651 samples were analysed. The median TAT from sample collection to laboratory receipt was 8 days (interquartile range [IQR]: 6-12), receipt to testing was 3 days (IQR: 1-7), and testing to result reporting was 6 days (IQR: 3-12). Altogether, the sample continuum averaged 16 days (IQR: 11-24). Lower level healthcare facilities were associated with longer sample delivery TATs. Calendar months (January and December) and larger sample volumes impacted testing and result reporting TATs. The cost per test was $4.46 (United States dollars [USD]) and $483.74 USD per positive case detected.

Conclusion: Uganda's sickle cell screening programme is efficient and cost-effective. Universal newborn screening is the best strategy for detecting sickle cell anaemia in Uganda.
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http://dx.doi.org/10.4102/ajlm.v10i1.1303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424771PMC
August 2021

HIV Viral Load Monitoring Among Patients Receiving Antiretroviral Therapy - Eight Sub-Saharan Africa Countries, 2013-2018.

MMWR Morb Mortal Wkly Rep 2021 May 28;70(21):775-778. Epub 2021 May 28.

One component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) goal to end the HIV/AIDS epidemic by 2030, is that 95% of all persons receiving antiretroviral therapy (ART) achieve viral suppression. Thus, testing all HIV-positive persons for viral load (number of copies of viral RNA per mL) is a global health priority (1). CDC and other U.S. government agencies, as part of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), together with other stakeholders, have provided technical assistance and supported the cost for multiple countries in sub-Saharan Africa to expand viral load testing as the preferred monitoring strategy for clinical response to ART. The individual and population-level benefits of ART are well understood (2). Persons receiving ART who achieve and sustain an undetectable viral load do not transmit HIV to their sex partners, thereby disrupting onward transmission (2,3). Viral load testing is a cost-effective and sustainable programmatic approach for monitoring treatment success, allowing reduced frequency of health care visits for patients who are virally suppressed (4). Viral load monitoring enables early and accurate detection of treatment failure before immunologic decline. This report describes progress on the scale-up of viral load testing in eight sub-Saharan African countries from 2013 to 2018 and examines the trajectory of improvement with viral load testing scale-up that has paralleled government commitments, sustained technical assistance, and financial resources from international donors. Viral load testing in low- and middle-income countries enables monitoring of viral load suppression at the individual and population level, which is necessary to achieve global epidemic control. Although there has been substantial achievement in improving viral load coverage for all patients receiving ART, continued engagement is needed to reach global targets.
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http://dx.doi.org/10.15585/mmwr.mm7021a2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8158895PMC
May 2021

Uganda's "EID Systems Strengthening" model produces significant gains in testing, linkage, and retention of HIV-exposed and infected infants: An impact evaluation.

PLoS One 2021 4;16(2):e0246546. Epub 2021 Feb 4.

Clinton Health Access Initiative, Kampala, Uganda.

Introduction: A review of Uganda's HIV Early Infant Diagnosis (EID) program in 2010 revealed poor retention outcomes for HIV-exposed infants (HEI) after testing. The review informed development of the 'EID Systems Strengthening' model: a set of integrated initiatives at health facilities to improve testing, retention, and clinical care of HIV-exposed and infected infants. The program model was piloted at several facilities and later scaled countrywide. This mixed-methods study evaluates the program's impact and assesses its implementation.

Methods: We conducted a retrospective cohort study at 12 health facilities in Uganda, comprising all HEI tested by DNA PCR from June 2011 to May 2014 (n = 707). Cohort data were collected manually at the health facilities and analyzed. To assess impact, retention outcomes were statistically compared to the baseline study's cohort outcomes. We conducted a cross-sectional qualitative assessment of program implementation through 1) structured clinic observation and 2) key informant interviews with health workers, district officials, NGO technical managers, and EID trainers (n = 51).

Results: The evaluation cohort comprised 707 HEI (67 HIV+). The baseline study cohort contained 1268 HEI (244 HIV+). Among infants testing HIV+, retention in care at an ART clinic increased from 23% (57/244) to 66% (44/67) (p < .0001). Initiation of HIV+ infants on ART increased from 36% (27/75) to 92% (46/50) (p < .0001). HEI receiving 1st PCR results increased from 57% (718/1268) to 73% (518/707) (p < .0001). Among breastfeeding HEI with negative 1st PCR, 55% (192/352) received a confirmatory PCR test, a substantial increase from baseline period. Testing coverage improved significantly: HIV+ pregnant women who brought their infants for testing after birth increased from 18% (67/367) to 52% (175/334) (p < .0001). HEI were tested younger: mean age at DBS test decreased from 6.96 to 4.21 months (p < .0001). Clinical care for HEI was provided more consistently. Implementation fidelity was strong for most program components. The strongest contributory interventions were establishment of 'EID Care Points', integration of clinical care, longitudinal patient tracking, and regular health worker mentorship. Gaps included limited follow up of lost infants, inconsistent buy-in/ownership of health facility management, and challenges sustaining health worker motivation.

Discussion: Uganda's 'EID Systems Strengthening' model has produced significant gains in testing and retention of HEI and HIV+ infants, yet the country still faces major challenges. The 3 core concepts of Uganda's model are applicable to any country: establish a central service point for HEI, equip it to provide high-quality care and tracking, and develop systems to link HEI to the service point. Uganda's experience has shown the importance of intensively targeting systemic bottlenecks to HEI retention at facility level, a necessary complement to deploying rapidly scalable technologies and other higher-level initiatives.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246546PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861549PMC
August 2021

Implementation and operational feasibility of SAMBA I HIV-1 semi-quantitative viral load testing at the point-of-care in rural settings in Malawi and Uganda.

Trop Med Int Health 2021 02 3;26(2):184-194. Epub 2020 Dec 3.

Médecins sans Frontières, Paris, France.

Objective: We monitored a large-scale implementation of the Simple Amplification-Based Assay semi-quantitative viral load test for HIV-1 version I (SAMBA I Viral Load = SAMBA I VL) within Médecins Sans Frontières' HIV programmes in Malawi and Uganda, to assess its performance and operational feasibility.

Methods: Descriptive analysis of routine programme data between August 2013 and December 2016. The dataset included samples collected for VL monitoring and tested using SAMBA I VL in five HIV clinics in Malawi (four peripheral health centres and one district hospital), and one HIV clinic in a regional referral hospital in Uganda. SAMBA I VL was used for VL testing in patients who had been receiving ART for between 6 months and ten years, to determine whether plasma VL was above or below 1000 copies/mL of HIV-1, reflecting ART failure or efficacy. Randomly selected samples were quantified with commercial VL assays. SAMBA I instruments and test performance, site throughput, and delays in communicating results to clinicians and patients were monitored.

Results: Between August 2013 and December 2016 a total of 60 889 patient samples were analysed with SAMBA I VL. Overall, 0.23% of initial SAMBA I VL results were invalid; this was reduced to 0.04% after repeating the test once. Global test failure, including instrument failure, was 1.34%. Concordance with reference quantitative testing of VL was 2620/2727, 96.0% (1338/1382, 96.8% in Malawi; 1282/1345, 95.3% in Uganda). For Chiradzulu peripheral health centres and Arua Hospital HIV clinic, where testing was performed on-site, same-day results were communicated to clinicians for between 91% and 97% of samples. Same-day clinical review was obtained for 84.7% across the whole set of samples tested.

Conclusions: SAMBA I VL testing is feasible for monitoring cohorts of 1000 to 5000 ART-experienced patients. Same-day results can be used to inform rapid clinical decision-making at rural and remote health facilities, potentially reducing time available for development of resistance and conceivably helping to reduce morbidity and mortality.
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http://dx.doi.org/10.1111/tmi.13519DOI Listing
February 2021

Trends in sickle cell trait and disease screening in the Republic of Uganda, 2014-2019.

Trop Med Int Health 2021 01 14;26(1):23-32. Epub 2020 Dec 14.

Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

Objective: Sickle cell disease is an important public health issue that is increasingly recognised as a substantial contributor to morbidity and early childhood mortality in sub-Saharan Africa. We aimed to provide information from large-scale, long-term sickle cell screening efforts in Africa.

Methods: We used nationally representative data from the centralised public health laboratory database in Uganda to examine epidemiological trends in sickle cell screening over a five-year period, comparing age and geographic adjustments to prevalence among different testing cohorts of children aged 0-24 months, and calculating screening coverage within high-burden districts.

Results: A total of 324 356 children aged 0-24 months were screened for sickle cell trait and disease from February 2014 to March 2019. A high national burden of sickle cell disease (0.9%) was confirmed among a cohort of samples co-tested with HIV. In the cohort of samples referred specifically for sickle cell testing, the overall prevalence of sickle cell disease was 9.7% and particularly elevated in high-burden districts where focused screening occurred. The majority of children were screened before age 4 months, but the sickle-specific cohort had a larger proportion of affected children tested between age 5-9 months, coincident with onset of disease signs and symptoms. Successful screening coverage of sickle cell disease births was achieved in several high-burden districts.

Conclusions: Examination and analysis of national sickle cell screening trends in Uganda documents the successes of focused screening strategies as an important step towards universal screening. With this evidence and increased healthcare provider knowledge, Uganda can optimise sickle cell diagnosis and management across the country.
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http://dx.doi.org/10.1111/tmi.13506DOI Listing
January 2021

Empowering newborn screening programs in African countries through establishment of an international collaborative effort.

J Community Genet 2020 Jul 15;11(3):253-268. Epub 2020 May 15.

American College of Medical Genetics and Genomics, Bethesda, MD, USA.

In an effort to explore new knowledge and to develop meaningful collaborations for improving child health, the First Pan African Workshop on Newborn Screening was convened in June 2019 in Rabat, Morocco. Participants included an informal network of newborn screening stakeholders from across Africa and global experts in newborn screening and sickle cell disease. Over 150 attendees, representing 20 countries, were present including 11 African countries. The agenda focused on newborn screening rationale, techniques, system development, implementation barriers, ongoing research, and collaborations both globally and across Africa. We provide an overview of the workshop and a description of the newborn screening activities in the 11 African countries represented at the workshop, with a focus on sickle cell disease.
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http://dx.doi.org/10.1007/s12687-020-00463-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7295888PMC
July 2020

Mitigating the effect of the COVID-19 pandemic on sickle cell disease services in African countries.

Lancet Haematol 2020 06 23;7(6):e430-e432. Epub 2020 Apr 23.

Center for Clinical Microbiology, Division of Infection and Immunity, Royal Free Hospital Campus, University College London, London, United Kingdom; Division of Infection and Immunity, University College London and National Institute for Health Research Biomedical Research Centre, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.

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http://dx.doi.org/10.1016/S2352-3026(20)30122-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7180020PMC
June 2020

Proportions of CD4 test results indicating advanced HIV disease remain consistently high at primary health care facilities across four high HIV burden countries.

PLoS One 2020 7;15(1):e0226987. Epub 2020 Jan 7.

Clinton Health Access Initiative, Boston, MA, United States of America.

Background: Globally, nearly 22 million HIV-infected patients are currently accessing antiretroviral treatment; however, almost one million people living with HIV died of AIDS-related illnesses in 2018. Advanced HIV disease remains a significant issue to curb HIV-related mortality.

Methods: We analyzed 864,389 CD4 testing records collected by 1,016 Alere Pima Analyzers implemented at a variety of facilities, including peripheral facilities, between January 2012 and December 2016 across four countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to analyze the median CD4 counts and proportions of patients with advanced HIV disease by country, facility type, and year.

Results: Median CD4 counts were between 409-444 cells/ul each year since 2012 with a median in 2016 of 444 cells/ul (n = 319,829). The proportion of test results returning CD4 counts above 500 cells/ul has increased slowly each year with 41.8% (95% CI: 41.6-41.9%) of tests having a CD4 count above 500 cells/ul in 2016. Median CD4 counts were similar across facility types. The proportion of test results indicating advanced HIV disease has remained fairly consistent: 19.4% (95% CI: 18.8-20.1%) in 2012 compared to 16.1% (95% CI: 16.0-16.3%) in 2016. The proportion of test results indicating advanced HIV disease annually ranged from 14.5% in Uganda to 29.8% in Cameroon. 6.9% (95% CI: 6.8-7.0%) of test results showed very advanced HIV disease (CD4<100 cells/ul) in 2016.

Conclusions: The proportion of CD4 test results indicating advanced disease was relatively high and consistent across four high HIV burden countries.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226987PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946176PMC
April 2020

Cryptococcal Antigenemia in Human Immunodeficiency Virus Antiretroviral Therapy-Experienced Ugandans With Virologic Failure.

Clin Infect Dis 2020 10;71(7):1726-1731

Infectious Diseases Institute, Makerere University, Kampala, Uganda.

Background: Detectable serum or plasma cryptococcal antigen (CrAg) precedes symptomatic cryptococcal meningitis. The World Health Organization recommends CrAg screening for human immunodeficiency virus-positive persons with CD4 count <100 cells/μL initiating antiretroviral therapy (ART). However, an increasing proportion of patients with cryptococcosis are now ART experienced. Whether CrAg screening is cost-effective in those with virologic failure is unknown.

Methods: We retrospectively performed nationwide plasma CrAg testing among ART-experienced Ugandan adults with virologic failure (≥1000 copies/mL) using leftover plasma after viral load testing during September 2017-January 2018. For those who were CrAg positive, we obtained ART history, meningitis occurrence, and 6-month survival via medical records review.

Results: Among 1186 subjects with virologic failure, 35 (3.0%) were CrAg positive with median ART duration of 41 months (interquartile range, 10-84 months). Among 25 subjects with 6-month outcomes, 16 (64%) survived, 7 (28%) died, and 2 (8%) were lost. One survivor had suffered cryptococcal meningitis 2 years prior. Two others developed cryptococcal meningitis and survived. Five survivors were known to have received fluconazole. Thus, meningitis-free survival at 6 months was 61% (14/23). Overall, 91% (32/35) of CrAg-positive persons had viral load ≥5000 copies/mL compared with 64% (735/1151) of CrAg-negative persons (odds ratio, 6.0 [95% confidence interval, 1.8-19.8]; P = .001). CrAg prevalence was 4.2% (32/768) among those with viral loads ≥5000 copies/mL and 0.7% (3/419) among those with viral loads <5000 copies/mL.

Conclusions: In addition to the CD4 threshold of <100 cells/μL, reflexive CrAg screening should be considered in persons failing ART in Uganda with viral loads ≥5000 copies/mL.
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http://dx.doi.org/10.1093/cid/ciz1069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755088PMC
October 2020

Use of an Indeterminate Range in HIV Early Infant Diagnosis: A Systematic Review and Meta-Analysis.

J Acquir Immune Defic Syndr 2019 11;82(3):281-286

Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.

Background: Expanded access to HIV antiretrovirals has dramatically reduced mother-to-child transmission of HIV. However, there is increasing concern around false-positive HIV test results in perinatally HIV-exposed infants but few insights into the use of indeterminate range to improve infant HIV diagnosis.

Methods: A systematic review and meta-analysis was conducted to evaluate the use of an indeterminate range for HIV early infant diagnosis. Published and unpublished studies from 2000 to 2018 were included. Study quality was evaluated using GRADE and QUADAS-2 criteria. A random-effects model compared various indeterminate ranges for identifying true and false positives.

Results: The review identified 32 studies with data from over 1.3 million infants across 14 countries published from 2000 to 2018. Indeterminate results accounted for 16.5% of initial non-negative test results, and 76% of indeterminate results were negative on repeat testing. Most results were from Roche tests. In the random-effects model, an indeterminate range using a polymerase chain reaction cycle threshold value of ≥33 captured over 93% of false positives while classifying fewer than 9% of true positives as indeterminate.

Conclusions: Without the use of an indeterminate range, over 10% of infants could be incorrectly diagnosed as HIV positive if their initial test results are not confirmed. Use of an indeterminate range appears to lead to substantial improvements in the accuracy of early infant diagnosis testing and supports current recommendations to confirm all initial positive tests.
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http://dx.doi.org/10.1097/QAI.0000000000002104DOI Listing
November 2019

Point-of-care CD4 technology invalid result rates in public health care settings across five countries.

PLoS One 2019 5;14(7):e0219021. Epub 2019 Jul 5.

Clinton Health Access Initiative, Boston, Massachusetts, United States of America.

Background: Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.

Methods: We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.

Results: Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.

Conclusions: Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0219021PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611583PMC
February 2020

A cholera outbreak caused by drinking contaminated river water, Bulambuli District, Eastern Uganda, March 2016.

BMC Infect Dis 2019 Jun 11;19(1):516. Epub 2019 Jun 11.

US Centres for Disease Control and Prevention, Atlanta, USA.

Background: A cholera outbreak started on 29 February in Bwikhonge Sub-county, Bulambuli District in Eastern Uganda. Local public health authorities implemented initial control measures. However, in late March, cases sharply increased in Bwikhonge Sub-county. We investigated the outbreak to determine its scope and mode of transmission, and to inform control measures.

Methods: We defined a suspected case as sudden onset of watery diarrhea from 1 March 2016 onwards in a resident of Bulambuli District. A confirmed case was a suspected case with positive stool culture for V. cholerae. We conducted descriptive epidemiologic analysis of the cases to inform the hypothesis on mode of transmission. To test the hypothesis, we conducted a case-control study involving 100 suspected case-patients and 100 asymptomatic controls, individually-matched by residence village and age. We collected seven water samples for laboratory testing.

Results: We identified 108 suspected cases (attack rate: 1.3%, 108/8404), including 7 confirmed cases. The case-control study revealed that 78% (78/100) of case-patients compared with 51% (51/100) of control-persons usually collected drinking water from the nearby Cheptui River (OR = 7.8, 95% CI = 2.7-22); conversely, 35% (35/100) of case-patients compared with 54% (54/100) of control-persons usually collected drinking water from borehole pumps (OR = 0.31, 95% CI = 0.13-0.65). The index case in Bwikhonge Sub-county had onset on 29 February but the outbreak had been on-going in the neighbouring sub-counties in the previous 3 months. V. cholera was isolated in 2 of the 7 river water samples collected from different locations.

Conclusions: We concluded that this cholera outbreak was caused by drinking contaminated water from Cheptui River. We recommended boiling and/or treating drinking water, improved sanitation, distribution of chlorine tablets to the affected villages, and as a long-term solution, construction of more borehole pumps. After implementing preventive measures, the number of cases declined and completely stopped after 6th April.
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http://dx.doi.org/10.1186/s12879-019-4036-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6558808PMC
June 2019

Sickle cell screening in Uganda: High burden, human immunodeficiency virus comorbidity, and genetic modifiers.

Pediatr Blood Cancer 2019 08 16;66(8):e27807. Epub 2019 May 16.

Ministry of Health, Kampala, Uganda.

Background: The Uganda Sickle Surveillance Study provided evidence for a large sickle burden among HIV-exposed infants in Uganda. To date, however, no large scale screening program has been developed for Central or East Africa.

Methods: A 3-year targeted sickle cell screening project in Uganda was designed by the Ministry of Health to (1) determine sickle cell trait and disease prevalence within high-burden districts, (2) document the prevalence among HIV-exposed and nonexposed children, (3) confirm previously suggested HIV comorbidity, and (4) estimate the co-inheritance of known genetic modifiers of sickle cell disease.

Results: A total of 163 334 dried blood spot samples collected between April 2015 and March 2018 were analyzed, including 112 352 samples within the HIV Early Infant Diagnosis program. A high burden with >1% sickle cell disease was found within targeted East Central and Mid-Northern districts, in both HIV-exposed and nonexposed children. Based on crude birth-rate data, 236 905 sickle cell trait births and 16 695 sickle cell disease births will occur annually in Uganda. Compared to sickle cell disease without HIV, the odds ratio of having sickle cell disease plus HIV was 0.50 (95% confidence interval = 0.40-0.64, P < .0001). Alpha-thalassemia trait and G6PD deficiency were common with sickle cell disease, but with different geospatial distribution.

Conclusions: High sickle cell burden and potential HIV comorbidity are confirmed in Uganda. Genetic modifiers are common and likely influence laboratory and clinical phenotypes. These prospective data document that targeted sickle cell screening is feasible and effective in Uganda, and support development of district-level comprehensive care programs.
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http://dx.doi.org/10.1002/pbc.27807DOI Listing
August 2019

Cost for sickle cell disease screening using isoelectric focusing with dried blood spot samples and estimation of price thresholds for a point-of-care test in Uganda.

J Blood Med 2019 5;10:59-67. Epub 2019 Feb 5.

Devices and Tools Global Program, PATH, Seattle, WA, USA,

Background: Early identification through newborn screening is the first step in active management of sickle cell disease (SCD). Uganda currently screens newborns and infants under 2 years for SCD in high HIV-burden districts using isoelectric focusing with dried blood spot samples. Our analysis sought to estimate the costs per child screened for SCD using this method in Uganda and then to use those data to estimate the price threshold for screening with a point-of-care (POC) test.

Methods: We estimated the financial and economic costs per child screened for SCD using data from health facilities and the Central Public Health Laboratory. These costs included sample collection, transportation, and laboratory processing. Price thresholds for a POC test were estimated using two scenarios.

Results: The price threshold of an SCD POC test used for diagnosis would be $3.77 when taking into account only financial costs and $5.14 when taking into account economic costs. Thresholds for a POC test used for screening would be $3.07-$3.51 and $4.38-$5.09, respectively, depending on test specificity.

Conclusion: The price threshold of a POC test for SCD will depend on the assumptions on how it will be used - either as a screening or diagnostic test. If used for screening, test specificity will have significant impact. Results from this type of costing study can allow developers to incorporate quantitatively estimated price thresholds for innovative products into target product profiles early in the product development cycle.
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http://dx.doi.org/10.2147/JBM.S186528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368125PMC
February 2019

Retention outcomes and drivers of loss among HIV-exposed and infected infants in Uganda: a retrospective cohort study.

BMC Infect Dis 2018 Aug 22;18(1):416. Epub 2018 Aug 22.

Clinton Health Access Initiative, Kampala, Uganda.

Background: Uganda's HIV Early Infant Diagnosis (EID) program rapidly scaled up testing of HIV-exposed infants (HEI) in its early years. However, little was known about retention outcomes of HEI after testing. Provision of transport refunds to HEI caregivers was piloted at 3 hospitals to improve retention. This study was conducted to quantify retention outcomes of tested HEI, identify factors driving loss-to-follow-up, and assess the effect of transport refunds on HEI retention.

Methods: This mixed-methods study included 7 health facilities- retrospective cohort review at 3 hospitals and qualitative assessment at all facilities. The cohort comprised all HEI tested from September-2007 to February-2009. Retention data was collected manually at each hospital. Qualitative methods included health worker interviews and structured clinic observation. Qualitative data was synthesized, analyzed and triangulated to identify factors driving HEI loss-to-follow-up.

Results: The cohort included 1268 HEI, with 244 testing HIV-positive. Only 57% (718/1268) of tested HEI received results. The transport refund pilot increased the percent of HEI caregivers receiving test results from 54% (n = 763) to 58% (n = 505) (p = .08). HEI were tested at late ages (Mean = 7.0 months, n = 1268). Many HEI weren't tested at all: at 1 hospital, only 18% (67/367) of HIV+ pregnant women brought their HEI for testing after birth. Among HIV+ infants, only 40% (98/244) received results and enrolled at an ART Clinic. Of enrolled HIV+ infants, only 43% (57/98) were still active in chronic care. 36% (27/75) of eligible HIV+ infants started ART. Our analysis identified 6 categories of factors driving HEI loss-to-follow-up: fragmentation of EID services across several clinics, with most poorly equipped for HEI care/follow-up; poor referral mechanisms and data management systems; inconsistent clinical care; substandard counseling; poor health worker knowledge of EID; long sample-result turnaround times.

Discussion: The poor outcomes for HEI and HIV+ infants have highlighted an urgent need to improve retention and linkage to care. To address the identified gaps, Uganda's Ministry of Health and the Clinton Health Access Initiative developed a new implementation model, shifting EID from a lab-based diagnostic service to an integrated clinic-based chronic care model. This model was piloted at 21 facilities. An evaluation is needed.
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http://dx.doi.org/10.1186/s12879-018-3275-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6104004PMC
August 2018

Where have all the children gone? High HIV prevalence in infants attending nutrition and inpatient entry points.

J Int AIDS Soc 2018 02;21(2)

Clinton Health Access Initiative, Kampala, Uganda.

Introduction: Despite notable progress towards PMTCT, only 50% of HIV-exposed infants in sub-Saharan Africa were tested within the first 2 months of life and only 30% of HIV-infected infants are on antiretroviral treatment. This study assessed HIV prevalence in infants and children receiving care at various service entry points in primary healthcare facilities in Uganda.

Methods: A total of 3600 infants up to 24 months of age were systematically enrolled and tested at four regional hospitals across Uganda. Six hundred infants were included and tested from six facility entry points: PMTCT, immunization, inpatient, nutrition, outpatient and community outreach services.

Findings: The traditional EID entry point, PMTCT, had a prevalence of 3.8%, representing 19.6% of the total HIV-positive infants identified in the study. Fifty percent of the 117 identified HIV-positive infants were found in the nutrition wards, which had a prevalence of 9.8% (p < 0.001 compared to PMTCT). Inpatient wards had a prevalence of 3.5% and yielded 17.9% of the HIV-positive infants identified. Infants tested at immunization wards and through outreach services identified 0.8% and 1.7% of the HIV-positive infants respectively, and had a prevalence of less than 0.3%.

Conclusions: Expanding routine early infant diagnosis screening beyond the traditional PMTCT setting to nutrition and inpatient entry points will increase the identification of HIV-infected infants. Careful reflection for appropriate testing strategies, such as maternal re-testing to identify new HIV infections and HIV-exposed infants in need of follow-up testing and care, at immunization and outreach services should be considered given the expectedly low prevalence rates. These findings may help HIV care programmes significantly expand testing to improve access to early infant diagnosis and paediatric treatment.
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http://dx.doi.org/10.1002/jia2.25089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426069PMC
February 2018

Rapid Serological Tests Ineffectively Screen for HIV Exposure in HIV-Positive Infants.

J Acquir Immune Defic Syndr 2018 03;77(3):331-336

Central Public Health Laboratory, Kampala, Uganda.

Background: Data on the performance and utility of rapid serological tests in infants to determine HIV exposure are unclear and in some instances contradictory. This study sought to understand the performance of rapid serological tests in high HIV burden, high Option B+ coverage settings to be used as an HIV exposure screening tool.

Methods: A total of 3600 infants up to 24 months of age at 4 regional hospitals in Uganda were systematically enrolled and tested simultaneously using both HIV rapid serological and nucleic acid-based tests.

Results: Only 58 of the 94 HIV-positive infants who received both rapid serological and nucleic acid-based tests were positive with the rapid serological test (sensitivity: 61.7%; 95% confidence interval: 51.1 to 71.5). Using rapid serological tests to screen infants for exposure to HIV and follow-up nucleic acid-based testing would have missed 38.3% (36 of 94) of HIV-positive infants. Finally, several HIV-positive infants who were negative by rapid serological test presented to well-child entry points and were considered healthy. All 3 HIV-positive infants presenting to outreach and immunization were negative by rapid serological testing and 73% (8 of 11) presenting to outpatient.

Conclusions: These data suggest that the use of rapid serological tests may have inadequate performance as an indicator of exposure and potential HIV infection among infants presenting at both well-child (immunization and community outreach) and sick-infant (nutrition and inpatient) entry points. To improve the identification of HIV-positive infants, nucleic acid-based testing should instead be considered in infants aged younger than 18 months.
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http://dx.doi.org/10.1097/QAI.0000000000001609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831382PMC
March 2018

Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting.

J Acquir Immune Defic Syndr 2017 10;76(2):e52-e57

*Kenya Medical Research Institute/US CDC Research and Public Health Collaboration (KEMRI-CDC), Kisumu, Kenya; †Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; ‡National Microbiology Reference Laboratory, Harare, Zimbabwe; §Médecins Sans Frontières, Paris, France; ‖African Society for Laboratory Medicine, Addis Ababa, Ethiopia; ¶School of Medicine, Johns Hopkins University, Baltimore, MD; and #NHS Blood and Transplant, London, United Kingdom; **Central Public Health Laboratory, Ministry of Health, Kampala, Uganda; ††Diagnostics Development Unit, Department of Haematology, University of Cambridge, Great Chesterford, United Kingdom; ‡‡Baylor-Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital, Kampala, Uganda; §§Ministry of Health and Child Care, Harare, Zimbabwe; ‖‖Diagnostics for the Real World Ltd., Sunnyvale, CA.

Introduction: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings.

Methods: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays.

Results: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples.

Discussion: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.
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October 2017

Factors Associated with Virological Non-suppression among HIV-Positive Patients on Antiretroviral Therapy in Uganda, August 2014-July 2015.

BMC Infect Dis 2017 05 3;17(1):326. Epub 2017 May 3.

Central Public Health Laboratories, Ministry of Health, Kampala, Uganda.

Background: Despite the growing number of people on antiretroviral therapy (ART), there is limited information about virological non-suppression and its determinants among HIV-positive (HIV+) individuals enrolled in HIV care in many resource-limited settings. We estimated the proportion of virologically non-suppressed patients, and identified the factors associated with virological non-suppression.

Methods: We conducted a descriptive cross-sectional study using routinely collected program data from viral load (VL) samples collected across the country for testing at the Central Public Health Laboratories (CPHL) in Uganda. Data were generated between August 2014 and July 2015. We extracted data on socio-demographic, clinical and VL testing results. We defined virological non-suppression as having ≥1000 copies of viral RNA/ml of blood for plasma or ≥5000 copies of viral RNA/ml of blood for dry blood spots. We used logistic regression to identify factors associated with virological non-suppression.

Results: The study was composed of 100,678 patients; of these, 94,766(94%) were for routine monitoring, 3492(4%) were suspected treatment failures while 1436(1%) were repeat testers after suspected failure. The overall proportion of non-suppression was 11%. Patients on routine monitoring registered the lowest (10%) proportion of non-suppressed patients. Virological non-suppression was higher among suspected treatment failures (29%) and repeat testers after suspected failure (50%). Repeat testers after suspected failure were six times more likely to have virological non-suppression (OR = 6.3, 95%CI = 5.5-7.2) when compared with suspected treatment failures (OR = 3.3, 95%CI = 3.0-3.6). The odds of virological non-suppression decreased with increasing age, with children aged 0-4 years (OR = 5.3, 95%CI = 4.6-6.1) and young adolescents (OR = 4.1, 95%CI = 3.7-4.6) registering the highest odds. Poor adherence (OR = 3.4, 95%CI = 2.9-3.9) and having active TB (OR = 1.9, 95%CI = 1.6-2.4) increased the odds of virological non-suppression. However, being on second/third line regimens (OR = 0.86, 95%CI = 0.78-0.95) protected patients against virological non-suppression.

Conclusion: Young age, poor adherence and having active TB increased the odds of virological non-suppression while second/third line ART regimens were protective against non-suppression. We recommend close follow up and intensified targeted adherence support for repeat testers after suspected failure, children and adolescents.
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http://dx.doi.org/10.1186/s12879-017-2428-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415758PMC
May 2017

Scale-up of Early Infant HIV Diagnosis and Improving Access to Pediatric HIV Care in Global Plan Countries: Past and Future Perspectives.

J Acquir Immune Defic Syndr 2017 May;75 Suppl 1:S51-S58

*World Health Organisation, HIV Department, Geneva, Switzerland; †UNICEF, New York, NY; ‡UNAIDS, Geneva, Switzerland; §Instituto Nacional da Saude, Maputo, Mozambique; ‖National Health Laboratory Service, Johannesburg, South Africa; ¶University of the Witwatersrand, Johannesburg, South Africa; #World Health Organisation, New Delhi, India; **Ministry of Health, Kampala, Uganda; ††Centers for Disease Control, Atlanta, GA; and ‡‡Clinton Health Access Initiative, Boston, MA.

Investment to scale-up early infant diagnosis (EID) of HIV has increased substantially in the last decade. This investment includes physical infrastructure, equipment, human resources, and specimen transportation systems as well as specialized mechanisms to deliver laboratory results to clinics. The Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive, as well as related international initiatives to prevent mother-to-child transmission of HIV and treat children living with HIV have been important drivers of this scale-up by mobilizing resources, creating advocacy, developing normative recommendations, and providing direct technical support to countries through the global community of international stakeholders. As a result, the number of early infant diagnosis tests performed annually has increased 10-fold between 2005 and 2015, and many thousands of infants are now receiving life-saving antiretroviral therapy because of this improved access. Despite these efforts and many success stories, timely infant diagnosis remains a challenge in many Global Plan countries. The most recent data (from the end of 2015) suggest a large variation in access. Some countries report that almost 90% of HIV-exposed infants are being tested; others report that the level of access has stagnated at 30%. Still, just over half of all exposed infants in Global Plan countries receive a test in the first 2 months of life. We discuss the key factors that are responsible for this scale-up of diagnostic capacity, highlight some of the challenges that have hampered progress, and describe priorities for the future that can help maintain momentum to achieve true universal access to HIV testing for children.
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May 2017

Progress with Scale-Up of HIV Viral Load Monitoring - Seven Sub-Saharan African Countries, January 2015-June 2016.

MMWR Morb Mortal Wkly Rep 2016 Dec 2;65(47):1332-1335. Epub 2016 Dec 2.

The World Health Organization (WHO) recommends viral load testing as the preferred method for monitoring the clinical response of patients with human immunodeficiency virus (HIV) infection to antiretroviral therapy (ART) (1). Viral load monitoring of patients on ART helps ensure early diagnosis and confirmation of ART failure and enables clinicians to take an appropriate course of action for patient management. When viral suppression is achieved and maintained, HIV transmission is substantially decreased, as is HIV-associated morbidity and mortality (2). CDC and other U.S. government agencies and international partners are supporting multiple countries in sub-Saharan Africa to provide viral load testing of persons with HIV who are on ART. This report examines current capacity for viral load testing based on equipment provided by manufacturers and progress with viral load monitoring of patients on ART in seven sub-Saharan countries (Côte d'Ivoire, Kenya, Malawi, Namibia, South Africa, Tanzania, and Uganda) during January 2015-June 2016. By June 2016, based on the target numbers for viral load testing set by each country, adequate equipment capacity existed in all but one country. During 2015, two countries tested >85% of patients on ART (Namibia [91%] and South Africa [87%]); four countries tested <25% of patients on ART. In 2015, viral suppression was >80% among those patients who received a viral load test in all countries except Côte d'Ivoire. Sustained country commitment and a coordinated global effort is needed to reach the goal for viral load monitoring of all persons with HIV on ART.
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http://dx.doi.org/10.15585/mmwr.mm6547a2DOI Listing
December 2016

Early Diagnosis of HIV Infection in Infants - One Caribbean and Six Sub-Saharan African Countries, 2011-2015.

MMWR Morb Mortal Wkly Rep 2016 Nov 25;65(46):1285-1290. Epub 2016 Nov 25.

Pediatric human immunodeficiency virus (HIV) infection remains an important public health issue in resource-limited settings. In 2015, 1.4 million children aged <15 years were estimated to be living with HIV (including 170,000 infants born in 2015), with the vast majority living in sub-Saharan Africa (1). In 2014, 150,000 children died from HIV-related causes worldwide (2). Access to timely HIV diagnosis and treatment for HIV-infected infants reduces HIV-associated mortality, which is approximately 50% by age 2 years without treatment (3). Since 2011, the annual number of HIV-infected children has declined by 50%. Despite this gain, in 2014, only 42% of HIV-exposed infants received a diagnostic test for HIV (2), and in 2015, only 51% of children living with HIV received antiretroviral therapy (1). Access to services for early infant diagnosis of HIV (which includes access to testing for HIV-exposed infants and clinical diagnosis of HIV-infected infants) is critical for reducing HIV-associated mortality in children aged <15 years. Using data collected from seven countries supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), progress in the provision of HIV testing services for early infant diagnosis was assessed. During 2011-2015, the total number of HIV diagnostic tests performed among HIV-exposed infants within 6 weeks after birth (tests for early infant diagnosis of HIV), as recommended by the World Health Organization (WHO) increased in all seven countries (Cote d'Ivoire, the Democratic Republic of the Congo, Haiti, Malawi, South Africa, Uganda, and Zambia); however, in 2015, the rate of testing for early infant diagnosis among HIV-exposed infants was <50% in five countries. HIV positivity among those tested declined in all seven countries, with three countries (Cote d'Ivoire, the Democratic Republic of the Congo, and Uganda) reporting >50% decline. The most common challenges for access to testing for early infant diagnosis included difficulties in specimen transport, long turnaround time between specimen collection and receipt of results, and limitations in supply chain management. Further reductions in HIV mortality in children can be achieved through continued expansion and improvement of services for early infant diagnosis in PEPFAR-supported countries, including initiatives targeted to reach HIV-exposed infants, ensure access to programs for early infant diagnosis of HIV, and facilitate prompt linkage to treatment for children diagnosed with HIV infection.
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November 2016

Hemoglobin variants identified in the Uganda Sickle Surveillance Study.

Blood Adv 2016 Nov 22;1(1):93-100. Epub 2016 Nov 22.

Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

The Uganda Sickle Surveillance Study analyzed dried blood spots that were collected from almost 100 000 infants and young children from all 10 regions and 112 districts in the Republic of Uganda, with the primary objective of determining the prevalence of sickle cell trait and disease. An overall prevalence of 13.3% sickle cell trait and 0.7% sickle cell disease was recently reported. The isoelectric focusing electrophoresis technique coincidentally revealed numerous hemoglobin (Hb) variants (defined as an electrophoresis band that was not Hb A, Hb F, Hb S, or Hb C) with an overall country-wide prevalence of 0.5%, but with considerable geographic variability, being highest in the northwest regions and districts. To elucidate these Hb variants, the original isoelectric focusing (IEF) gels were reviewed to identify and locate the variant samples; corresponding dried blood spots were retrieved for further testing. Subsequent DNA-based investigation of 5 predominant isoelectric focusing patterns identified 2 α-globin variants (Hb Stanleyville II, Asn78Lys; Hb G-Pest, Asp74Asn), 1 β-globin variant (Hb O-Arab, Glu121Lys), and 2 fusion globin variants (Hb P-Nilotic, β31-δ50; Hb Kenya, γ81Leu-β86Ala). Compound heterozygotes containing an Hb variant plus Hb S were also identified, including both Hb S/O-Arab and HbS/Kenya. Regional differences in the types and prevalence of these hemoglobin variants likely reflect tribal ancestries and migration patterns. Algorithms are proposed to characterize these Hb variants, which will be helpful for emerging neonatal hemoglobinopathy screening programs that are under way in sub-Saharan Africa.
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http://dx.doi.org/10.1182/bloodadvances.2016000950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5744056PMC
November 2016

Burden of sickle cell trait and disease in the Uganda Sickle Surveillance Study (US3): a cross-sectional study.

Lancet Glob Health 2016 Mar 29;4(3):e195-200. Epub 2016 Jan 29.

Ministry of Health for the Republic of Uganda, Kampala, Uganda.

Background: Sickle cell disease contributes substantially to mortality in children younger than 5 years in sub-Saharan Africa. In Uganda, 20,000 babies per year are thought to be born with sickle cell disease, but accurate data are not available. We did the cross-sectional Uganda Sickle Surveillance Study to assess the burden of disease.

Methods: The primary objective of the study was to calculate prevalence of sickle cell trait and disease. We obtained punch samples from dried blood spots routinely collected from HIV-exposed infants in ten regions and 112 districts across Uganda for the national Early Infant Diagnosis programme. Haemoglobin electrophoresis by isoelectric focusing was done on all samples to identify those from babies with sickle trait or disease.

Findings: Between February, 2014, and March, 2015, 99,243 dried blood spots were analysed and results were available for 97,631. The overall number of children with sickle cell trait was 12,979 (13·3%) and with disease was 716 (0·7%). Sickle cell numbers ranged from 631 (4·6%) for trait and 23 (0·2%) for disease of 13,649 in the South Western region to 1306 (19·8%) for trait and 96 (1·5%) for disease of 6581 in the East Central region. Sickle cell trait was seen in all districts. The lowest prevalence was less than 3·0% in two districts. Eight districts had prevalence greater than 20·0%, with the highest being 23·9%. Sickle cell disease was less common in children older than 12 months or who were HIV positive, which is consistent with comorbidity and early mortality.

Interpretation: Prevalence of sickle cell trait and disease were high in Uganda, with notable variation between regions and districts. The data will help to inform national strategies for sickle cell disease, including neonatal screening.

Funding: Cincinnati Children's Research Foundation.
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http://dx.doi.org/10.1016/S2214-109X(15)00288-0DOI Listing
March 2016

Scale-up of HIV Viral Load Monitoring--Seven Sub-Saharan African Countries.

MMWR Morb Mortal Wkly Rep 2015 Nov 27;64(46):1287-90. Epub 2015 Nov 27.

To achieve global targets for universal treatment set forth by the Joint United Nations Programme on human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (UNAIDS), viral load monitoring for HIV-infected persons receiving antiretroviral therapy (ART) must become the standard of care in low- and middle-income countries (LMIC) (1). CDC and other U.S. government agencies, as part of the President's Emergency Plan for AIDS Relief, are supporting multiple countries in sub-Saharan Africa to change from the use of CD4 cell counts for monitoring of clinical response to ART to the use of viral load monitoring, which is the standard of care in developed countries. Viral load monitoring is the preferred method for immunologic monitoring because it enables earlier and more accurate detection of treatment failure before immunologic decline. This report highlights the initial successes and challenges of viral load monitoring in seven countries that have chosen to scale up viral load testing as a national monitoring strategy for patients on ART in response to World Health Organization (WHO) recommendations. Countries initiating viral load scale-up in 2014 observed increases in coverage after scale-up, and countries initiating in 2015 are anticipating similar trends. However, in six of the seven countries, viral load testing coverage in 2015 remained below target levels. Inefficient specimen transport, need for training, delays in procurement and distribution, and limited financial resources to support scale-up hindered progress. Country commitment and effective partnerships are essential to address the financial, operational, technical, and policy challenges of the rising demand for viral load monitoring.
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November 2015

Consolidating HIV testing in a public health laboratory for efficient and sustainable early infant diagnosis (EID) in Uganda.

J Public Health Policy 2015 May 26;36(2):153-69. Epub 2015 Mar 26.

Central Public Health Laboratories, Ministry of Health, 7-11 Buganda Road, Kampala 256 41, Uganda.

Uganda introduced an HIV Early Infant Diagnosis (EID) program in 2006, and then worked to improve the laboratory, transportation, and clinical elements. Reported here are the activities involved in setting up a prospective analysis in which the Ministry of Health, with its NGO partners, determined it would be more effective and efficient to consolidate the initial eight-laboratory system for EID testing of HIV dried blood samples offered by two nongovernmental partners operating research facilities into a single well-equipped and staffed laboratory within the Ministry. A retrospective analysis confirmed that redesign reduced overhead cost per PCR test of HIV dried blood samples from US$22.20 to an average of $5. Along with the revamped system of sample collection, transportation, and result communication, Uganda has been able to vastly increase the HIV diagnosis of babies and engagement of them and their mothers in clinical care, including antiretroviral therapy. Uganda reduced turnaround times for results reporting to clinicians from more than a month in 2006 to just 2 weeks by 2014, even as samples tested increased dramatically. The next challenge is overcoming loss of babies and mothers to follow up.
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http://dx.doi.org/10.1057/jphp.2015.7DOI Listing
May 2015

Evidence from the field: missed opportunities for identifying and linking HIV-infected children for early initiation of ART.

AIDS 2013 Nov;27 Suppl 2:S139-46

aHIV Section, UNICEF, New York, USA bRegional Office, Eastern and Southern Africa, UNICEF, Johannesburg, South Africa cInter-country Support Team, Eastern and Southern Africa, WHO, Harare, Zimbabwe dGlobal HIV Technical Lead, Management Sciences for Health, Arlington, Virginia eGlobal HIV Programme, Clinton Health Access, New York, USA fNational AIDS Control Programme, Ministry of Health, Dar-Es-Salaam, Tanzania gNational STD/AIDS Control Programme, Ministry of Health, Kampala, Uganda hNational HIV Treatment Programme, Ministry of Health, Harare, Zimbabwe.

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November 2013
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