Reaching Men and Young Adults in a Pharmacy-Based HIV Self-Testing Strategy: Results from an Acceptability Study in Mozambique.

HIV self-testing (HIVST) is a WHO-recommended strategy to increase testing, especially among key populations, men, and young adults. Between May and December 2019, a pilot was implemented in Zambézia province, Mozambique, allowing clients to purchase HIV self-tests in 14 public/private pharmacies. The study assessed the strategy's acceptability and uptake. Pharmacy-based exit surveys were conducted among a random sample of clients, during the first three months of the pilot, independent of HIVST purchase. Another random sample of clients who bought an HIVST completed a survey 1-12 weeks after purchase. Chi-square and Mann-Whitney tests were used for the analysis, comparing clients who purchased an HIVST versus not. A total of 1,139 adults purchased 1,344 tests. Buyers were predominantly male (70%) and younger (52% between 15 and 34 years of age). Surveys were completed by 280 exiting pharmacy clients and 82 clients who purchased an HIVST. Main advantages were confidentiality and lack of need of a health provider visit, with main disadvantages being absence of nearby counseling and fear of results. No differences were seen between buyers and non-buyers for these factors. Among all undergoing HIVST, 71 (92%) perceived the instructions to be clear, however, 29 (38%) stated they would have benefitted from additional pre-test information or counseling. Ten (13%) reported following up at a nearby health facility to confirm results and/or receive care. Offering HIVST at public/private pharmacies was acceptable among people who traditionally tend to have a lower HIV testing coverage, such as men and young adults. However, additional resources and/or enhanced educational materials to address the lack of counseling, and linkage-to-care systems need to be put into place before scaling up this strategy.

Diagnóstico de infección por Helicobacter pylori mediante test de aliento con urea C-14 en población ecuatoriana / Diagnosis of Helicobacter pylori infection by C-14 urea breath test in Ecuadorian population

siendo el test de aliento con urea carbono-14 (C-14) uno de los métodos de diagnóstico no invasivos; sin embar-go, no ha sido comprobada su utilidad en la población ecuatoriana.Objetivo: Evaluar la sensibilidad y especificidad del test de aliento con urea C-14 para predecir la infección por HP en la población ecuatoriana.Métodos: Estudio de Pruebas Diagnósticas realizado en pacientes que acudieron a la consulta externa del servicio de gastroenterología del Hospital Teófilo Dávila de la ciudad de Machala, en el periodo abril 2018 a marzo 2019. Los pacientes se sometieron a una endoscopia superior de luz blanca (ES) con toma de biopsias para investigar la infec-ción por HP; además, se realizó un test de aliento con urea C-14, para compararla con los resultados de las biopsias.Resultados: Se estudiaron 78 pacientes con una edad media de 33.76±11.2 años. El diagnóstico de gastritis se confirmó a través de la ES e histopatología en el 100% de los pacientes. El test de aliento con urea C-14 fue positi-va en 47/78 (60.3%) pacientes. Se demostró evidencia de infección por HP en biopsias gástricas de 50/78 (64.1%) pacientes. La sensibilidad, especificidad, VPP, VPN, observada y la concordancia entre evaluadores fue de 94%, 100%, 100%, 90%, 96% y 92% (P <0.001), respectivamente.Conclusiones: El test de aliento con urea C-14, es una herramienta útil para predecir infección por HP en la población ecuatoriana

Background: Early detection of Helicobacter pylori infection has become more relevant, with urea carbon-14 (C-14) breath test as one of the non-invasive diagnostic methods; however, it has not been proven in Ecuadorian population.Objective: To evaluate the sensitivity and specificity of the C-14 urea breath test to predict HP infection in the Ecuadorian population.Methods: : Study of diagnostic tests performed on patients who attended the outpatient gastroenterology service of the Hospital Teófilo Dávila in the city of Machala, in the period April 2018 to March 2019. The patients underwent an upper endoscopy of white light (WLE) with biopsies taken to investigate HP infection. In addition, a breath test with C-14 urea was performed to compare it with the biopsies results.Results: 78 patients with a mean age of 33.76±11.2 years were studied. The diagnosis of gastritis was confirmed through endoscopy and histopathology in 100% of the patients. The breath test with urea C-14 was positive in 47/78 (60.3%) patients. Evidence of HP infection was demonstrated in gastric biopsies from 50/78 (64.1%) pa-tients. Sensitivity, specificity, PPV, NPV, and inter-rater reliability were 94%, 100%, 100%, 90%, 96%, and 92% (P <0.001), respectively.Conclusions: The C-14 urea breath test is a useful tool for predicting HP infection in the Ecuadorian population

HIV Rapid Diagnostic Test Inventories in Zambézia Province, Mozambique: A Tale of 2 Test Kits.

BACKGROUND: The first pillar of the UNAIDS 90-90-90 goal seeks to accurately identify persons living with HIV (PLHIV), a process that is predicated on facilities having the necessary HIV tests available to perform the task. In many rural settings, the identification of PLHIV is accomplished through a two-step process involving the sequential use of 2 separate rapid diagnostic tests (RDTs). Inadequate inventory of either test has ramifications for the success of HIV-related programs. The purpose of this study was to evaluate the inventory levels of HIV RDT kits at specific healthcare facilities in Zambézia province, Mozambique. METHODS: Using facility-level pharmacy stock surveillance data from October 2015 through September 2016, we assessed the inventory levels of HIV RDTs at 75 health facilities in 8 districts within Zambézia province, Mozambique. Using programmatically established categories (good, sufficient, threatened, or stockout), defined in conjunction with the provincial health authorities, descriptive statistics were performed to determine inventory control of HIV RDTs at the district and health facility levels. Monthly proportions of adequate (good + sufficient) inventory were calculated for each district to identify inventory trends over the evaluation period. To assess whether the proportion of inadequate stocks differed between RDT, a mixed-effects logistic regression was conducted, with inadequate inventory status as the outcome of interest. RESULTS: When viewed as a whole, the inventory of each test kit was reported as being at adequate levels more than 89% of the time across the 75 facilities. However, disaggregated analysis revealed significant variability in the inventory levels of HIV RDTs at the district level. Specifically, the districts of Inhassunge, Namacurra, and Pebane reported inadequate inventory levels (threatened + stockout), of one or both test kits, for more than 10% of the study period. In addition, a disparity between inventory levels of each test kit was identified, with the odds of reporting inadequate inventory levels of the confirmatory test (Uni-Gold™) being approximately 1.8-fold greater than the initial test (Determine™) (odds ratio: 1.82, 95% CI: 1.40-2.38). CONCLUSION: As Test and Treat programs evolve, a significant emphasis should be placed on the "test" component of the strategy, beginning with assurances that health facilities have the adequate inventory of RDT necessary to meet the needs of their community. As national policy-makers rely predominantly on data from the upstream arm of the supply chain, it is unlikely the disparity between inventory levels of HIV RDTs identified at individual districts and specific health facilities would have been recognized. Moving forward, our findings point to a need for (1) renewed efforts reinforcing appropriate downstream forecasting of essential medicines and diagnostic tests in general and for Uni-Gold™ test kits specifically, and (2) simple metrics that may be routinely collected at all health facilities and which may then easily and quickly flow upstream so that policy-makers may optimally allocate resources.

Practical Management of HIV-Associated Anemia in Resource-Limited Settings: Prospective Observational Evaluation of a New Mozambican Guideline.

Mozambique's updated guideline for management of HIV-associated anemia prompts clinicians to consider opportunistic conditions, adverse drug reactions, and untreated immunosuppression in addition to iron deficiency, intestinal helminthes, and malaria. We prospectively evaluated this guideline in rural Zambézia Province. Likely cause(s) of anemia were determined through prespecified history, physical examination, and laboratory testing. Diagnoses were "etiologic" if laboratory confirmed (sputum microscopy, blood culture, Plasmodium falciparum malaria rapid test) or "syndromic" if not. To assess hemoglobin response, we used serial point-of-care measurements. We studied 324 ambulatory, anemic (hemoglobin <10 g/dl) HIV-infected adults. Study clinicians treated nearly all [315 (97.2%)] for suspected iron deficiency and/or helminthes; 56 (17.3%) had laboratory-confirmed malaria. Other assigned diagnoses included tuberculosis [30 (9.3%)], adverse drug reactions [26 (8.0%)], and bacteremia [13 (4.1%)]. Etiologic diagnosis was achieved in 79 (24.4%). Of 169 (52.2%) subjects who improved (hemoglobin increase of ≥1 g/dl without indications for hospitalization), only 65 (38.5%) received conventional management (iron supplementation, deworming, and/or antimalarials) alone. Thirty (9.3%) died and/or were hospitalized, and 125 (38.6%) were lost to follow-up. Multivariable linear and logistic regression models described better hemoglobin responses and/or outcomes in subjects with higher CD4(+) T-lymphocyte counts, pre-enrollment antiretroviral therapy and/or co-trimoxazole prophylaxis, discontinuation of zidovudine for suspected adverse reaction, and smear-positive tuberculosis. Adverse outcomes were associated with fever, low body mass index, bacteremia, esophageal candidiasis, and low or missing CD4(+) T cell counts. In this severely resource-limited setting, successful anemia management often required interventions other than conventional presumptive treatment, thus supporting Mozambique's guideline revision.

Identification of Invasive Salmonella Enterica Serovar Typhimurium ST313 in Ambulatory HIV-Infected Adults in Mozambique.

INTRODUCTION: Despite evidence describing the burden of invasive non-typhoidal salmonella (iNTS) disease in sub-Saharan Africa, iNTS is not recognized as a priority within global health policy institutions. Recently, Salmonella enterica serovar Typhimurium, sequence type (ST) 313, has been identified as the predominant cause of iNTS disease in multiple sub-Saharan African countries. MATERIALS AND METHODS: We conducted multilocus sequence typing (MLST) to determine the prevalence of the ST313 genotype in a sample of blood isolates from ambulatory HIV-infected Mozambican adults with iNTS disease. RESULTS: Of the 29 samples of NTS obtained and analyzed by MLST, all (29/29) were assigned the ST313 sequence type based on the set of allele types derived from each of the seven loci. For quality control, five randomly selected strains taken from the original cultures were confirmed as ST313, and the positive control strain SL3261 (taken from the original culture) was categorized as S. Typhimurium ST19. CONCLUSION: S. Typhimurium ST313 is an important example of a widely distributed pathogen that lacks a coordinated strategy for control. The highly vulnerable populations at risk for ST313 infection in Mozambique, and within the region, would benefit greatly from the development of new policy and on-the-ground capacity to support increased surveillance, prevention, and treatment initiatives.

Management of fever in ambulatory HIV-infected adults in resource-limited settings: prospective observational evaluation of a new Mozambican guideline.

A new Mozambican guideline for management of fever in HIV-infected adults requires malaria testing and systematic consideration of specific alternative diagnoses (eg, tuberculosis and bacterial infections) in addition to malaria. We conducted a prospective observational study of the guideline's performance. Of 258 HIV-infected subjects with axillary temperature ≥37.5° C or history of fever, 76.0% improved, 13.6% died or were hospitalized, and 10.5% were lost to follow-up. In multivariate analyses, factors associated with adverse outcomes were bacterial blood stream infection, syndromically diagnosed tuberculosis, lower CD4 T-lymphocyte count, no antiretroviral therapy, lower body mass index, lower hemoglobin, and nonprescription of antibiotics.

Bacteremia as a cause of fever in ambulatory, HIV-infected Mozambican adults: results and policy implications from a prospective observational study.

Fever is typically treated empirically in rural Mozambique. We examined the distribution and antimicrobial susceptibility patterns of bacterial pathogens isolated from blood-culture specimens, and clinical characteristics of ambulatory HIV-infected febrile patients with and without bacteremia. This analysis was nested within a larger prospective observational study to evaluate the performance of new Mozambican guidelines for fever and anemia in HIV-infected adults (clinical trial registration NCT01681914, www.clinicaltrials.gov); the guidelines were designed to be used by non-physician clinicians who attended ambulatory HIV-infected patients in very resource-constrained peripheral health units. In 2012 (April-September), we recruited 258 HIV-infected adults with documented fever or history of recent fever in three sites within Zambézia Province, Mozambique. Although febrile patients were routinely tested for malaria, blood culture capacity was unavailable in Zambézia prior to study initiation. We confirmed bacteremia in 39 (15.1%) of 258 patients. The predominant organisms were non-typhoid Salmonella, nearly all resistant to multiple first-line antibiotics (ampicillin, chloramphenicol, and trimethoprim-sulfamethoxazole). Features most associated with bacteremia included higher temperature, lower CD4+ T-lymphocyte count, lower hemoglobin, and headache. Introduction of blood cultures allowed us to: 1) confirm bacteremia in a substantial proportion of patients; 2) tailor specific antimicrobial therapy for confirmed bacteremia based on known susceptibilities; 3) make informed choices of presumptive antibiotics for patients with suspected bacteremia; and 4) construct a preliminary clinical profile to help clinicians determine who would most likely benefit from presumptive bacteremia treatment. Our findings demonstrate that in resource-limited settings, there is urgent need to expand local microbiologic capacity to better identify and treat cases of bacteremia in HIV-infected and other patients, and to support surveillance. Data on the prevalence and susceptibility patterns of important pathogens can guide national formulary and prescribing practices.

Molecular and structural characterization of HIV-1 subtype B Brazilian isolates with GWGR tetramer at the tip of the V3-loop.

One of most intriguing features of the HIV-1 subtype B epidemic in Brazil is the high frequency of isolates exhibiting tryptophan (W) in the tetramer (GWGR) at the tip of the V3 loop. We observed that the frequencies of glutamic and aspartic acids at site 25 of the V3 loop are quite distinct in GWGR isolates compared with viruses with other tetramers. The basic amino acids at sites 11 and 25 of V3 are strongly linked with CCR5-to-CXCR4 coreceptor shift. We therefore predicted phenotype usage and found that GWGR isolates are exclusively CCR5-using. Further evidence of this came from intrahost sequences, where basic amino acid substitutions at sites 11 and 25 emerged only in isolates presenting a tryptophan-to-glycine replacement at the tetramer of the V3. In addition, modeled 3D-structures of the V3 loop of GWGR and GGGR in intrahost viruses differ essentially in the binding region of the coreceptor.