Brief report: Validation of a quantitative HIV risk prediction tool using a national HIV testing cohort.
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ABSTRACT:
SUBMITTER: Haukoos JS
PROVIDER: S-EPMC4357562 | biostudies-literature | 2015 Apr
REPOSITORIES: biostudies-literature
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Brief report: Validation of a quantitative HIV risk prediction tool using a national HIV testing cohort.
Haukoos Jason S JS Hopkins Emily E Bucossi Meggan M MM Lyons Michael S MS Rothman Richard E RE White Douglas A E DA Al-Tayyib Alia A AA Bradley-Springer Lucy L Campbell Jonathan D JD Sabel Allison L AL Thrun Mark W MW
Journal of acquired immune deficiency syndromes (1999) 20150401 5
Routine screening is recommended for HIV detection. HIV risk estimation remains important. Our goal was to validate the Denver HIV Risk Score using a national cohort from the Centers for Disease Control and Prevention. Patients of 13 years and older were included, 4,830,941 HIV tests were performed, and 0.6% newly diagnosed infections were identified. Of all visits, 9% were very low risk (HIV prevalence = 0.20%), 27% low risk (HIV prevalence = 0.17%), 41% moderate risk (HIV prevalence = 0.39%), ...[more]
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Project description:BackgroundPediatric HIV testing remains suboptimal. The OraQuick test [saliva-based test (SBT)] is validated in pediatric populations ≥18 months. Understanding caregiver and health care worker (HCW) acceptability of pediatric SBT is critical for implementation.MethodsA trained qualitative interviewer conducted 8 focus group discussions (FGDs): 4 with HCWs and 4 with caregivers of children seeking health services in western Kenya. FGDs explored acceptability of pediatric SBT and home- and facility-based SBT use. Two reviewers conducted consensus coding and thematic analyses of transcripts using Dedoose.ResultsMost HCWs but few caregivers had heard of SBT. Before seeing SBT instructions, both had concerns about potential HIV transmission through saliva, which were mostly alleviated after kit demonstration. Noted benefits of SBT included usability and avoiding finger pricks. Benefits of facility-based pediatric SBT included shorter client waiting and service time, higher testing coverage, and access to HCWs, while noted challenges included ensuring confidentiality. Benefits of caregivers using home-based SBT included convenience, privacy, decreased travel costs, increased testing, easier administration, and child comfort. Perceived challenges included not receiving counseling, disagreements with partners, child neglect, and negative emotional response to a positive test result. Overall, HCWs felt that SBT could be used for pediatric HIV testing but saw limited utility for caregivers performing SBT without an HCW present. Caregivers saw utility in home-based SBT but wanted easy access to counseling in case of a positive test result.ConclusionsSBT was generally acceptable to HCWs and caregivers and is a promising strategy to expand testing coverage.
| S-EPMC9283261 | biostudies-literature
Project description:BackgroundVRC01 is a human IgG1 broadly neutralizing antibody (bnAb) that binds to the HIV-1 envelope glycoprotein. It is being evaluated in two ongoing Phase 2b trials, the first efficacy assessment of a passively-administered bnAb for HIV-1 prevention. HVTN 104 was a phase 1 trial of VRC01.SettingWe measured serum concentrations and serum neutralization of VRC01 in 1079 longitudinal samples collected after passive administration of VRC01 in 84 HVTN 104 participants. As assays for measuring VRC01 serum neutralization titers are resource-intensive, we investigated approaches to predicting such titers.MethodsSerum concentration was measured using an anti-idiotypic ELISA assay. Serum neutralization ID50 titers and in vitro neutralization potency IC50 of the VRC01 clinical lot were measured against Env-pseudoviruses. Three approaches were used to predict serum neutralization ID50 titers based on (1) observed serum concentration divided by IC50, (2) pharmacokinetics model-predicted serum concentration divided by IC50, and (3) joint modeling of the longitudinal serum concentrations and ID50 titers.ResultsAll 3 approaches yielded satisfactory prediction of neutralization titers against viruses of varied sensitivities; the median fold differences (FDs) of observed-over-predicted ID50 titers were between 0.95 and 1.37. Approach 3 generally performed the best with fold differences between 0.95 and 0.99 and <82% mean squared prediction error relative to approach 1. Similar results were obtained for ID80 titers.ConclusionVRC01 serum neutralization could be accurately predicted, especially when using pharmacokinetics models. The proposed prediction approaches could potentially save significant resources for the characterization of serum neutralization of VRC01, including for other bnAbs and bnAb combinations.
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Project description:Prediction of lifetime cardiovascular disease (CVD) risk is recommended in many clinical guidelines, but lifetime risk models are rarely externally validated. The aim of this study was to externally validate the QRiskLifetime incident CVD risk prediction tool. Independent external validation of QRiskLifetime using Clinical Practice Research Datalink data, examining discrimination and calibration in the whole population and stratified by age, and reclassification compared to QRISK3. Since lifetime CVD risk is unobservable, performance was evaluated at 10-years' follow-up, and lifetime performance inferred in terms of performance for in the different age-groups from which lifetime predictions are derived. One million, two hundreds sixty thousand and three hundreds twenty nine women and 1,223,265 men were included in the analysis. Discrimination was excellent in the whole population (Harrell's-C = 0.844 in women, 0.808 in men), but moderate to poor stratified by age-group (Harrell's C in people aged 30-44 0.714 for both men and women, in people aged 75-84 0.578 in women and 0.556 in men). Ten-year CVD risk was under-predicted in the whole population, and in all age-groups except women aged 45-64, with worse under-prediction in older age-groups. Compared to those at highest QRISK3 estimated 10-year risk, those with highest lifetime risk were younger (mean age: women 50.5 vs. 71.3 years; men 46.3 vs. 63.8 years) and had lower systolic blood pressure and prevalence of treated hypertension, but had more family history of premature CVD, and were more commonly minority ethnic. Over 10-years, the estimated number needed to treat (NNT) with a statin to prevent one CVD event in people with QRISK3 ≥ 10% was 34 in women and 37 in men, compared to 99 and 100 for those at highest lifetime risk. QRiskLifetime underpredicts 10-year CVD risk in nearly all age-groups, so is likely to also underpredict lifetime risk. Treatment based on lifetime risk has considerably lower medium-term benefit than treatment based on 10-year risk.
| S-EPMC10105395 | biostudies-literature
Project description:Screening persons living with HIV for gonorrhea and chlamydia has been recommended since 2003. We compared annual gonorrhea/chlamydia testing to syphilis and lipid testing among 19,368 adults (41% men who have sex with men, 30% heterosexual men, and 29% women) engaged in HIV care. In 2004, 22%, 62%, and 70% of all patients were tested for gonorrhea/chlamydia, syphilis, and lipid levels, respectively. Despite increasing steadily [odds ratio per year (95% confidence interval): 1.14 (1.13 to 1.15)], gonorrhea/chlamydia testing in 2010 remained lower than syphilis and lipid testing (39%, 77%, 76%, respectively). Interventions to improve gonorrhea/chlamydia screening are needed. A more targeted screening approach may be warranted.
| S-EPMC4607588 | biostudies-literature
Project description:ObjectiveAlthough statins are widely prescribed lipid-lowering drugs, there are concerns about the safety of their use in the context of coronavirus disease 2019 (COVID-19), since statins increase the expression of ACE2 (angiotensin-converting enzyme 2). This study aimed to disclose the association between statins and 60-day COVID-19 mortality. Approach and Results: All patients hospitalized with laboratory-confirmed COVID-19 were enrolled in this study from January 19 to April 16, 2020, in Korea. We evaluated the association between the use of statins and COVID-19-related mortality in the overall and the nested 1:2 propensity score-matched study. Furthermore, a comparison of the hazard ratio for death was performed between COVID-19 patients and a retrospective cohort of patients hospitalized with pneumonia between January and June 2019 in Korea. The median age of the 10 448 COVID-19 patients was 45 years. Statins were prescribed in 533 (5.1%) patients. After adjusting for age, sex, and comorbidities, Cox regression showed a significant decrease in hazard ratio associated with the use of statins (hazard ratio, 0.637 [95% CI, 0.425-0.953]; P=0.0283). Moreover, on comparing the hazard ratio between COVID-19 patients and the retrospective cohort of hospitalized pneumonia patients, the use of statins showed similar benefits.ConclusionsThe use of statins correlates significantly with lower mortality in patients with COVID-19, consistent with the findings in patients with pneumonia. Graphic Abstract: A graphic abstract is available for this article.
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Project description:BACKGROUND:Prompt child HIV testing and treatment is critical; however, children are often not diagnosed until symptomatic. Understanding factors that influence pediatric HIV testing can inform strategies to increase testing. METHODS:A mixed-methods study was conducted at a tertiary hospital in Nairobi, Kenya. Three focus group discussions with health care workers (HCWs) and 18 in-depth interviews with HIV-infected adults with children of unknown status were analyzed using thematic analysis. A structured questionnaire was administered to 116 HIV-infected caregivers of children of unknown status to triangulate qualitative findings. RESULTS:Analysis revealed 3 key periods of the pediatric HIV testing process: decision to test, test visit, and posttest. Key issues included: decision to test: inaccurate HIV risk perception for children, challenges with paternal consent, lack of caregiver HIV status disclosure to partners or older children; test experience: poor understanding of child consent/assent and disclosure guidelines, perceived costs of testing and care, school schedules, HCW discomfort with pediatric HIV testing; and posttest: pessimism regarding HIV-infected children's prognosis, caregiver concerns about their own emotional health if their child is positive, and challenges communicating about HIV with children. Concerns about all 3 periods influenced child testing decisions. In addition, 3 challenges were unique to pediatric HIV: inaccurate HIV risk perception for children; disclosure, consent, and permission; and costs and scheduling. CONCLUSIONS:Pediatric HIV testing barriers are distinct from adult barriers. Uptake of pediatric HIV testing may be enhanced by interventions to address misconceptions, disclosure services, psychosocial support addressing concerns unique to pediatric testing, child-focused HCW training, and alternative clinic hours.
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Project description:BackgroundRepeat HIV viral load (VL) testing is required after unsuppressed VL to confirm treatment failure. We assessed proportion of adolescents and young adults living with HIV (AYALHIV) in Kenya with a confirmatory VL test and time to repeat testing.DesignA retrospective analysis of longitudinal data abstracted from Kenya's national VL database.MethodsVL data for AYALHIV who were 10-24 year old between April 2017 and May 2019 were abstracted from 117 HIV care clinics. Records were eligible if at least one VL test was performed ≥6 months after antiretroviral therapy (ART) initiation. The proportion of unsuppressed AYALHIV (≥1000 copies/mL) and time in months between first unsuppressed VL and repeat VL was determined.ResultsWe abstracted 40,928 VL records for 23,969 AYALHIV; of whom, 17,092 (71%) were eligible for this analysis. Of these, 12,122 (71%) were women, median age of 19 years [interquartile range (IQR): 13-23], and median ART duration of 38 months (IQR: 16-76). Among eligible AYALHIV, 4010 (23%) had an unsuppressed VL at first eligible measurement. Only 316 (8%) of the unsuppressed AYALHIV had a repeat VL within 3 months and 1176 (29%) within 6 months. Among 2311 virally unsuppressed AYALHIV with a repeat VL, the median time between the first and the repeat VL was 6 months (IQR: 4-8), with 1330 (58%) having confirmed treatment failure.ConclusionsOne-quarter of AYALHIV on ART had unsuppressed VL, with less than a third receiving a repeat VL within 6 months. Strategies to improve VL testing practices are needed to improve AYALHIV's outcomes.
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Project description:An increasing number of U.S. emergency departments (EDs) have implemented ED-based HIV testing programs since the Centers for Disease Control and Prevention issued revised HIV testing recommendations for clinical settings in 2006. In 2010, the National HIV/AIDS Strategy (NHAS) set an linkage-to-care (LTC) rate goal of 85% within 90 days of HIV diagnosis. LTC rates for newly diagnosed HIV-infected patients vary markedly by site, and many are suboptimal. The optimal approach for LTC in the ED setting remains unknown.The objective was to perform a brief descriptive analysis of the LTC methods practiced in EDs across the United States to determine the overall linkage rate of ED-based HIV testing programs.We conducted a systematic review of literature related to U.S. ED HIV testing in the adult population using PubMed, Embase, Web of Science, Scopus, and Cochrane. There were 333 articles were identified; 31 articles were selected after a multiphasic screening process. We analyzed data from the 31 articles to assess LTC methods and rates. LTC methods that involved physical escort of the newly diagnosed patient to an HIV/infectious disease (ID) clinic or interaction with a specialist health care provider at the ED were operationally defined as "intensive" LTC protocol. "Mixed" LTC protocol was defined as a program that employed intensive linkage only part of the coverage hours. All other forms of linkage was defined as "nonintensive" LTC protocol. An LTC rate of ?85% was used to identify characteristics of ED-based HIV testing program associated with a higher LTC rate.There were 37 ED-based HIV testing programs in the 31 articles. The overall LTC rate was 74.4%. Regarding type of protocol, nine (24.3%) employed intensive LTC protocols, 25 (67.6%) nonintensive, two (5.4%) mixed, and one (2.7%) with unclear protocols. LTC rates for programs with intensive and nonintensive LTC protocols were 80.0 and 72.7%, respectively. Four (44.4%) with intensive protocols and nine (36.0%) with the nonintensive protocols had LTC rates > 85%. The linkage staff employed was different between ED programs. Among them, 25 (67.6%) programs used exogenous staff, 10 (27.0%) used the ED staff, and two had no information. All the programs in the nonintensive group utilized drop-in HIV/ID clinic or medical appointments while seven of nine of the programs in the intensive group physically escorted the patients to the initial medical intake appointment. There were no significant differences in characteristics of ED-based HIV testing programs between those with ?85% LTC rate versus those with <85% within the intensive or nonintensive group.Intensive LTC protocols had a higher LTC rate and a higher proportion of programs that surpassed the >85% NHAS goal compared to nonintensive methods, suggesting that, when possible, ED-based HIV testing programs should adopt intensive LTC strategies to improve LTC outcomes. However, intensive LTC protocols most often required involvement of multidisciplinary non-ED professionals and external research funding. Our findings provide a foundation for developing best practices for ED-based HIV LTC programs.
| S-EPMC4938722 | biostudies-other
Project description:ObjectivesTo develop a brief, reliable and valid instrument to screen psychosocial risk among those who are undergoing genetic testing for Adult-Onset Hereditary Disease (AOHD).DesignA prospective two-phase cohort study.Setting5 genetic testing centres for AOHD, such as cancer, Huntington's disease or haemochromatosis, in ambulatory clinics of tertiary hospitals across Canada.Participants141 individuals undergoing genetic testing were approached and consented to the instrument development phase of the study (Phase I). The Genetic Psychosocial Risk Instrument (GPRI) developed in Phase I was tested in Phase II for item refinement and validation. A separate cohort of 722 individuals consented to the study, 712 completed the baseline package and 463 completed all follow-up assessments. Most participants were female, at the mid-life stage. Individuals in advanced stages of the illness or with cognitive impairment or a language barrier were excluded.InterventionsPhase I: GPRI items were generated from (1) a review of the literature, (2) input from genetic counsellors and (3) phase I participants. Phase II: further item refinement and validation were conducted with a second cohort of participants who completed the GPRI at baseline and were followed for psychological distress 1-month postgenetic testing results.Primary and secondary outcome measuresGPRI, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Brief Symptom Inventory (BSI) and Impact of Event Scale (IES).ResultsThe final 20-item GPRI had a high reliability-Cronbach's ? at 0.81. The construct validity was supported by high correlations between GPRI and BSI and IES. The predictive value was demonstrated by a receiver operating characteristic curve of 0.78 plotting GPRI against follow-up assessments using HAM-D and HAM-A.ConclusionsWith a cut-off score of 50, GPRI identified 84% of participants who displayed distress postgenetic testing results, supporting its potential usefulness in a clinical setting.
| S-EPMC3612753 | biostudies-literature
Project description:INTRODUCTION:Anemia is a potential adverse effect of phlebotomy during participation in research. Clinical studies of acute HIV infection (AHI) require frequent phlebotomy to maximize scientific yield, but this participant population may also be at increased risk for anemia and other adverse events. OBJECTIVE:The objective of this study was to describe baseline and longitudinal hemoglobin changes among participants with AHI. METHODS:Participants with AHI (n = 202) were enrolled in a prospective cohort study in Thailand. AHI was diagnosed using pooled nucleic acid testing and sequential HIV antibody immunoassays. Antiretroviral therapy was initiated on enrollment. During 48 weeks of study participation, a total of 629 mL of blood was drawn over 14 visits. Hemoglobin levels were measured serially, and abnormalities were graded using the Division of AIDS (National Institute of Allergy and Infectious Diseases) adverse event table. RESULTS:AHI was diagnosed at a median of 18 days after infection. Mean hemoglobin at enrollment of male participants was 14.8 g/dL, and for females, it was 13.0 g/dL. Over 48 weeks, there was a mean increase of 0.2 g/dL among men (P = 0.01) and a decrease of 0.7 g/dL among women (P = 0.03). The overall prevalence of anemia was low, with 7 (3.5%) of 202 fulfilling grade 1 or 2 anemia criteria. CONCLUSIONS:Anemia was rare after frequent phlebotomy in research participants with AHI, before and after antiretroviral therapy. Given that the blood volume drawn from this study did not pose substantial clinical risk, increasing the volume of blood drawn for research purposes in acute HIV-infected research participants could be considered for future studies.
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