Dataset Information

Accuracy and user-acceptability of HIV self-testing using an oral fluid-based HIV rapid test.

ABSTRACT:

Background

The United States FDA approved an over-the-counter HIV self-test, to facilitate increased HIV testing and earlier linkage to care. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants' ability to interpret sample results and user-acceptability of self-tests in Singapore.

Methodology/principal findings

A cross-sectional study, involving 200 known HIV-positive patients and 794 unknown HIV status at-risk participants was conducted. Participants (all without prior self-test experience) performed self-testing guided solely by visual instructions, followed by HCW testing, both using the OraQuick ADVANCE Rapid HIV 1/2 Antibody Test, with both results interpreted by the HCW. To assess ability to interpret results, participants were provided 3 sample results (positive, negative, and invalid) to interpret. Of 192 participants who tested positive on HCW testing, self-testing was positive in 186 (96.9%), negative in 5 (2.6%), and invalid in 1 (0.5%). Of 794 participants who tested negative on HCW testing, self-testing was negative in 791 (99.6%), positive in 1 (0.1%), and invalid in 2 (0.3%). Excluding invalid tests, self-testing had sensitivity of 97.4% (95% CI 95.1% to 99.7%) and specificity of 99.9% (95% CI: 99.6% to 100%). When interpreting results, 96%, 93.1% and 95.2% correctly read the positive, negative and invalid respectively. There were no significant demographic predictors for false negative self-testing or wrongly interpreting positive or invalid sample results as negative. Eighty-seven percent would purchase the kit over-the-counter; 89% preferred to take HIV tests in private. 72.5% and 74.9% felt the need for pre- and post-test counseling respectively. Only 28% would pay at least USD15 for the test.

Conclusions/significance

Self-testing was associated with high specificity, and a small but significant number of false negatives. Incorrectly identifying model results as invalid was a major reason for incorrect result interpretation. Survey responses were supportive of making self-testing available.

SUBMITTER: Ng OT

PROVIDER: S-EPMC3444491 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Accuracy and user-acceptability of HIV self-testing using an oral fluid-based HIV rapid test.

Ng Oon Tek OT Chow Angela L AL Lee Vernon J VJ Chen Mark I C MI Win Mar Kyaw MK Tan Hiok Hee HH Chua Arlene A Leo Yee Sin YS

PloS one 20120917 9

<h4>Background</h4>The United States FDA approved an over-the-counter HIV self-test, to facilitate increased HIV testing and earlier linkage to care. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants' ability to interpret sample results and user-acceptability of self-tests in Singapore.<h4>Methodology/principal findings</h4>A cross-sectional study, involving 200 known HIV-positive patients and 794 unknown HIV status at-ri ...[more]

PMID: 23028822

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Project description:BackgroundTargeted HIV testing strategies are needed to reach remaining undiagnosed people living with HIV and achieve the UNAIDS' 95-95-95 goals for 2030. HIV self-testing (HIVST) can increase uptake of HIV testing among young people, but user perspectives on novel distribution methods are uncertain. We assess the acceptability, perceived challenges, and recommendations of young adult lay counselor-led campus-based HIVST delivery among tertiary school students aged 18-24 years in Zimbabwe.MethodsWe purposively sampled participants from an intervention involving campus-based HIVST using lay workers for distribution. We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) among young adults from 10 universities and colleges in Zimbabwe who: (1) self-tested on campus; (2) self-tested off campus; and (3) opted not to self-test. We audio recorded and transcribed all interviews. Using applied thematic analysis, two investigators identified emergent themes and independently coded transcripts, achieving high inter-coder agreement.ResultsOf the 52 young adults (53.8% male, 46.1% female) interviewed through 26 IDIs and four FGDs, most IDI participants (19/26, 73%) favored campus-based HIVST, describing it as a more autonomous, convenient, and socially acceptable experience than other facility or community-based HIV testing services. Despite general acceptability, participants identified challenges with this delivery model, including: perceived social coercion, insufficient privacy and access to post-test counseling. These challenges influenced some participants to opt against self-testing (6/52, 11.5%). Recommendations for improved implementation included integrating secondary distribution of test kits and increased HIV counseling options into campus-based programs.ConclusionsBarriers to HIV testing among young people are numerous and complex. As the number of new HIV infections among youth continue to grow worldwide, targeted strategies and youth friendly approaches that increase access to testing are needed to close the diagnostic coverage gap. This is the first study to describe young adult acceptance of campus-based delivery of HIVST by lay counselors in Zimbabwe.

Project description:BackgroundThe prevalence of HIV in Uganda is 7.3%, and yet nearly 40% of people living with HIV are unaware of their status. The current HIV testing policy which is strictly blood-based poses several challenges including: a need for high level laboratory skills, stringent waste disposal needs, and painful sample collection. It is envisaged that introduction of a rapid, painless HIV oral fluid test as a potential alternative is likely to increase the number of people testing. The aim of this study was to determine the diagnostic accuracy and acceptability of rapid HIV oral testing among adults attending Kisenyi Health Centre IV in Kampala.Methods and findingsWe conducted a cross-sectional study among 440 adults recruited consecutively at Kisenyi Health Centre IV from January to March 2016. The diagnostic accuracy of the HIV oral test was assessed by comparing to the national HIV serial testing algorithm. We also assessed for acceptability among patients and health care workers (HCWs) by triangulating responses from a structured questionnaire, three focus group discussions and seven key informant interviews. Acceptability was defined as willingness to take the test at the time of the study and intention for future use of the test if it was availed. The prevalence of HIV infection among study participants was 14.8%. The HIV oral fluid test was highly accurate with sensitivity of 100% (95% CI; 94.5-100.0), specificity of 100% (95% CI; 99.0-100.0), positive predictive value (PPV) of 100% (95% CI; 94.5-100.0) and negative predictive value (NPV) of 100% (95% CI; 99.0-100.0). Acceptability of HIV oral testing was also high at 87.0% (95% CI; 83.6-89.9). Participants preferred HIV oral testing because it was: pain free (91%, n = 399) and did not require blood draw (82%, n = 360).ConclusionThe HIV oral fluid test has high diagnostic accuracy and acceptability. HIV oral testing is a suitable addition to the national HIV testing strategies with the potential of increasing access to HIV testing services in Uganda.

Project description:INTRODUCTION:HIV self-testing can increase coverage of essential HIV services. This study aimed to establish the acceptability, concordance and feasibility of supervised HIV self-testing among pregnant women in rural India. METHODS:A cross-sectional, mixed methods study was conducted among 202 consenting pregnant women in a rural Indian hospital between August 2014 and January 2015. Participants were provided with instructions on how to self-test using OraQuick(®) HIV antibody test, and subsequently asked to self-test under supervision of a community health worker. Test results were confirmed at a government-run integrated counselling and testing centre. A questionnaire was used to obtain information on patient demographics and the ease, acceptability and difficulties of self-testing. In-depth interviews were conducted with a sub-sample of 35 participants to understand their experiences. RESULTS:In total, 202 participants performed the non-invasive, oral fluid-based, rapid test under supervision for HIV screening. Acceptance rate was 100%. Motivators for self-testing included: ease of testing (43.4%), quick results (27.3%) and non-invasive procedure (23.2%). Sensitivity and specificity were 100% for 201 tests, and one test was invalid. Concordance of test result interpretation between community health workers and participants was 98.5% with a Cohen's Kappa (k) value of k=0.566 with p<0.001 for inter-rater agreement. Although 92.6% participants reported that the instructions for the test were easy to understand, 18.7% required the assistance of a supervisor to self-test. Major themes that emerged from the qualitative interviews indicated the importance of the following factors in influencing acceptability of self-testing: clarity and accessibility of test instructions; time-efficiency and convenience of testing; non-invasiveness of the test; and fear of incorrect results. Overall, 96.5% of the participants recommended that the OraQuick(®) test kits should become publicly available. CONCLUSIONS:Self-testing for HIV status using an oral fluid-based rapid test under the supervision of a community health worker was acceptable and feasible among pregnant women in rural India. Participants were supportive of making self-testing publicly available. Policy guidelines and implementation research are required to advance HIV self-testing for larger populations at scale.

Project description:BackgroundTesting pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India.Methods and findingsAfter they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%-1.8%). Of the 15 HIV test-positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery.ConclusionsIn a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries.

Dataset Information

Accuracy and user-acceptability of HIV self-testing using an oral fluid-based HIV rapid test.

Background

Methodology/principal findings

Conclusions/significance

Publications

Accuracy and user-acceptability of HIV self-testing using an oral fluid-based HIV rapid test.

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