National HIV Prevention Conference Atlanta, Georgia, USA — July 27 - 30, 2003

HIV Home Self-Testing: Can It Work?

Natl HIV Prev Conf 2003 July 27-30:abstract no. M1-A0101

Spielberg F, Camp S, Ramachandra E
University of Washington, Seattle, WA

BACKGROUND/OBJECTIVES:: Survey studies report preferences for HIV home self-testing by people who have never tested. Simple rapid tests now exist which could be used for home self-testing, however, no data exists on the feasibility of self-testing. The goal of this study is to determine the potential for the OraQuick oral fluid and finger-stick rapid HIV tests to be used as self-tests.

METHODS: This study was conducted among 240 HIV positive patients in a clinic in Seattle, prior to FDA approval of the OraQuick test. Participants were provided with kits and instructions and asked to perform oral fluid and finger-stick self-tests without training or assistance. Information was collected on difficulties encountered with specimen collection, test performance, blinded interpretation of results and control specimens, and acceptability. For seven waves, after each 20 clients, changes were made to participant instructions and test procedures in an effort to decrease participant difficulties. After the seven waves, instructions were fixed and 100 more participants were asked to perform the tests.

RESULTS: Some difficulties in performing both oral fluid (4.3 to 4.0%) and finger-stick self-tests (14% to 9%) leading to invalid or false negative results were decreased through changes made to instructions and labeling between the first and second halves of the study. The most common difficulty lead to invalid results and involved failure to put the test device in the vial with developer solution (N=17 to 9). Overall participants had less difficulty performing oral fluid tests (95% concordance with staff performance) as compared to finger-stick tests (89%), and more difficulty interpreting oral fluid tests (95% concordance with staff interpretation) than finger-stick tests (97%), due to difficulty interpreting weak positive oral fluid test results. If invalid test results (N= 14 OF, 27 FS) are excluded, participants were able to accurately perform and interpret 94% of both oral fluid and finger-stick self-tests. Regarding acceptability of self-testing, most participants said that if they were unaware of their HIV status they would prefer to be tested at home (61%). Cost would impact uptake of home self-tests in that 70% would be willing to pay up to $15, whereas only 40% would purchase the kit if the price were at $20.

CONCLUSION: Despite some difficulties in performing the tests, this study shows that self-testing using the OraQuick finger stick and oral fluid tests can be performed and interpreted with fairly good accuracy by untrained people. Future studies should determine the acceptability, accuracy and safety of self testing for HIV among populations that are currently unaware of their HIV status, and should develop necessary counseling and support systems to ensure access to care for people newly diagnosed with HIV. Self-testing for HIV has the potential to be a powerful new tool in the diagnosis of HIV infection.

030727
M1-A0101

Copyright notice: The National HIV Prevention Conference is collaborative effort by the Centers for Disease Control and Prevention, a U.S. Government agency and other governmental and non-government organizations. All abstracts published in by the conference organizers are in the public domain and can be used without permission. Proper citation, however, is required.