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A Multicenter Evaluation

Allan P. Frank, MD; Michael G. Wandell, PharmD; Milton D. Headings, MA; Marcus A. Conant, MD; George E. Woody, MD; Catherine Michel, PhD

Arch Intern Med. 1997;157(3):309-314.

Abstract
Background
Home human immunodeficiency virus (HIV) testing has been proposed as an alternative to conventional HIV testing. Despite debate over HIV type 1 (HIV-1) home test systems, these concerns have not to our knowledge been previously studied.

Objective
To evaluate the safety and efficacy of the Home Access Health Corp (Hoffman Estates, Ill) HIV-1 test system compared with traditional HIV-1 testing with venous blood.

Methods
A total of 1255 subjects were studied prospectively in a blinded, subject-as-control evaluation at 9 outpatient clinics using intent-to-treat analysis. Subjects were provided a home collection kit (Home Access Health Corp) to collect their own finger-stick blood spot samples for laboratory analysis. Subjects received pretest counseling by telephone and their comprehension was subsequently assessed. Subject-collected blood spot samples were compared with professionally drawn blood spot samples for adequacy (sufficient for completing the Food and Drug Administration—endorsed testing) and with venous samples for accuracy. Subjects called 3 days later for anonymous results and posttest counseling. Device safety was evaluated based on adverse events incidence. Subject comprehension of HIV information was measured.

Results
Subject-collected blood spot sample results were in complete agreement with venous blood sample results, demonstrating 100% sensitivity and 100% specificity compared with venous controls. Ninety-eight percent of subjects obtained testable blood spot specimens compared with phlebotomists. Following pretest counseling, subjects answered 96% of HIV risk questions correctly. There were no significant adverse events.

Conclusion
Anonymous HIV-1 home collection kits with pretest and posttest telephone counseling can provide a safe and effective alternative to conventional venous HIV-1 antibody testing.

Arch Intern Med. 1997;157:309-314

Author Affiliations
From the Department of Medicine, Illinois Masonic Medical Center, Chicago (Dr Frank); Home Access Health Corp, Hoffman Estates, Ill (Dr Wandell and Mr Headings); University of California Medical Center, San Francisco (Dr Conant); Department of Psychiatry, University of Pennsylvania, and Philadelphia Veteran Affairs Medical Center, Philadelphia, Pa (Dr Woody); and Corning Besselaar, Princeton, NJ (Dr Michel),

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