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 references 18

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

Bernard M. Branson, H. Hunter Handsfield, Margaret Lampe … (2006)

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.

Melanie Thompson, Judith Aberg, Pedro Cahn … (2010)

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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User acceptability and feasibility of self-testing with HIV rapid tests.

Vernon J. Lee, Soon Choon Tan, Arul Earnest … (2007)

Because HIV rapid tests are considered for self-testing, this study aims to determine the user acceptability and feasibility of self-testing. A cross-sectional study was performed on 350 systematically sampled participants across 2 Singapore HIV testing centers using the Abbott Determine HIV 1/2 blood sample rapid test (Abbott Laboratories, Abbott Park, IL). Participants were surveyed on knowledge of and attitudes toward rapid testing. To determine interrater agreement between self-testing and trained personnel testing, participants performed self-testing with visual instructions, followed by trained personnel testing. Ability to identify test outcomes was determined through interpretation of sample test results. Eighty-nine percent of participants preferred testing in private, but most indicated that confidential counseling by trained counselors was necessary. Almost 90% found the kit easy to use and instructions easy to understand. Nevertheless, 85% failed to perform all steps correctly, especially blood sampling, and 56% had invalid results because of incorrect test performance. Interrater agreement between results from self-testing and trained personnel testing had a kappa value of 0.28. Twelve percent could not correctly determine results using sample tests, including 2% and 7% who read positive and negative samples, respectively, incorrectly. A substantial proportion could not perform self-testing or identify outcomes. Self-testing with the Determine HIV 1/2 kit in Singapore should be deferred.

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Author and article information

Contributors

Patrick S. Sullivan: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2012

Publication date (Electronic): 8 October 2012

Volume: 7

Issue: 10

Electronic Location Identifier: 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.

* E-mail: jhoyos@ 123456isciii.es

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

Publisher ID: PONE-D-12-08042

DOI: 10.1371/journal.pone.0046555

PMC ID: 3466298

PubMed ID: 23056342

SO-VID: fe4058fe-1eb0-4a91-8c48-01a1d0d40e8f

License:

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

Date received : 16 March 2012

Date accepted : 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.

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

Methods

Results

Conclusions

Related collections

Point-of-Care Testing for HIV

Most cited references 18

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

Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel.

User acceptability and feasibility of self-testing with HIV rapid tests.

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