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      Are Participants in a Street-Based HIV Testing Program Able to Perform Their Own Rapid Test and Interpret the Results?

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          Abstract

          Objective

          Availability of over-the-counter rapid HIV tests could improve access to testing those reluctant or unable to use current services. We aimed to evaluate the feasibility of HIV self-testing using a finger-stick whole-blood rapid test (Determine™ HIV Combo) to detect both antigen and antibody.

          Methods

          Before being tested, 313 participants in a street-based testing program were given adapted instructions and a test kit, and performed the self-test without supervision. These participants, together with another 207 who performed supervised self-testing, received additional instructions on how to interpret the test results shown in six colour photos and filled out a questionnaire. Logistic regression and generalized estimating equations (GEE) were used in the statistical analysis.

          Results

          About 8.0% (95%CI:4.8%–11.2%) obtained an invalid self-test. An invalid result was inversely associated with male participants who had sex with men (OR = 0.3;95%CI:0.1–1.0). Of the 3111 photos interpreted,4.9% (95%CI:4.1–5.7) were incorrect. Only 1.1% (95%CI:0.3–1.8) of the positive results were interpreted as negative. Age 30 or older (OR = 2.1; 95%CI:1.2–3.7), having been born in Latin America (OR = 1.6; 95%CI:1.1–2.2),and not having university education (OR = 2.1;95%CI:1.2–3.7) were associated with misinterpreting test results in the GEE. Participant's perceptions of both their proficiency when conducting the test and interpretation were related with actual outcomes. Most participants (83.9%) were more motivated than before to use the self-test in the future, and 51.7% would pay >10 Euros for the test if it was sold in pharmacies.

          Conclusions

          This is the first study showing that blood-based self-testing with current technology is feasible in HIV-negative participants demanding the test and without prior training or supervision. Bearing in mind that it was conducted under difficult weather conditions and using a complex kit, over-the-counter tests could be a feasible option to complement current diagnostic strategies. More studies are needed to accommodate technology, minimise interpretation mistakes and provide on-line support.

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          Most cited references18

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          Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings.

          These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only. They do not modify existing guidelines concerning HIV counseling, testing, and referral for persons at high risk for HIV who seek or receive HIV testing in nonclinical settings (e.g., community-based organizations, outreach settings, or mobile vans). The objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. These revised recommendations update previous recommendations for HIV testing in health-care settings and for screening of pregnant women (CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42[No. RR-2]:1-10; CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1-62; and CDC. Revised recommendations for HIV screening of pregnant women. MMWR 2001;50[No. RR-19]:63-85). Major revisions from previously published guidelines are as follows: For patients in all health-care settings HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Persons at high risk for HIV infection should be screened for HIV at least annually. Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings. For pregnant women HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.
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            Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel.

            Recent data regarding the consequences of untreated human immunodeficiency virus (HIV) infection and the expansion of treatment choices for antiretroviral-naive and antiretroviral-experienced patients warrant an update of the International AIDS Society-USA guidelines for the use of antiretroviral therapy in adults with HIV infection. To provide updated recommendations for management of HIV-infected adults, using antiretroviral drugs and laboratory monitoring tools available in the international, developed-world setting. This report provides guidelines for when to initiate antiretroviral therapy, selection of appropriate initial regimens, patient monitoring, when to change therapy, and what regimens to use when changing. A panel with expertise in HIV research and clinical care reviewed relevant data published or presented at selected scientific conferences since the last panel report through April 2010. Data were identified through a PubMed search, review of scientific conference abstracts, and requests to antiretroviral drug manufacturers for updated clinical trials and adverse event data. New evidence was reviewed by the panel. Recommendations were drafted by section writing committees and reviewed and edited by the entire panel. The quality and strength of the evidence were rated and recommendations were made by full panel consensus. Patient readiness for treatment should be confirmed before initiation of antiretroviral treatment. Therapy is recommended for asymptomatic patients with a CD4 cell count 500/microL. Components of the initial and subsequent regimens must be individualized, particularly in the context of concurrent conditions. Patients receiving antiretroviral treatment should be monitored regularly; treatment failure should be detected and managed early, with the goal of therapy, even in heavily pretreated patients, being HIV-1 RNA suppression below commercially available assay quantification limits.
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              Diagnosed and undiagnosed HIV-infected populations in Europe.

              This article aims to build a picture of HIV epidemiology in Europe by combining existing surveillance data to mathematical modelling to achieve observations closer to the dynamic reality of HIV infections across different parts of Europe. In the European Union (EU), where it is estimated that 30% of HIV-infected persons have not been diagnosed, the number of new HIV diagnoses has risen in recent years. However, trends must be interpreted with some caution around the differences and variations in surveillance systems and testing rates among affected populations and regions. By introducing mathematical models, we can build an overall picture from the pieces of information available. We present a mathematical model of the course of infection and the effect of ART which has been developed to fit as closely as possible to observed data from HIV cohorts. The preliminary estimates for the entire WHO European Region are that around 2.3 million people were living with HIV in Europe at the end of 2006, of whom around 50% have not been diagnosed. The model can also be used to assess the potential impact of earlier diagnoses. Observations show how a combination of surveillance data and modelling allows an estimation of the current state of the epidemic in Europe, though further developments in both areas are needed.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2012
                8 October 2012
                : 7
                : 10
                : e46555
                Affiliations
                [1 ]Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain
                [2 ]CIBER Epidemiología y Salud Pública, Madrid, Spain
                [3 ]Servicio de Medicina Preventiva, Hospital Central de la Cruz Roja San José y Santa Adela, Madrid, Spain
                [4 ]Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain
                Rollins School of Public Health, Emory University, United States of America
                Author notes

                ¶ Membership of the Madrid Rapid HIV Testing Group is provided in the Acknowledgments.

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: LdlF M.J. Bravo M.J. Belza. Performed the experiments: SS SFB MERS MRHIVTG JP. Analyzed the data: JH MERS . Wrote the paper: LdlF M.J. Belza MERS GB.

                Article
                PONE-D-12-08042
                10.1371/journal.pone.0046555
                3466298
                23056342
                fe4058fe-1eb0-4a91-8c48-01a1d0d40e8f
                Copyright @ 2012

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 16 March 2012
                : 3 September 2012
                Page count
                Pages: 10
                Funding
                This study was funded by Fundación para la Investigación y Prevención del Sida en España (FIPSE: 36634/07) and by the Fondo de Investigación Sanitaria (FIS:PI09/9074). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine
                Anatomy and Physiology
                Immune Physiology
                Antibodies
                Antigens
                Diagnostic Medicine
                Test Evaluation
                Infectious Diseases
                Viral Diseases
                HIV
                HIV diagnosis and management
                HIV epidemiology
                HIV prevention
                Public Health
                Health Screening

                Uncategorized
                Uncategorized

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