Ap. Frank et al., ANONYMOUS HIV TESTING USING HOME COLLECTION AND TELEMEDICINE COUNSELING - A MULTICENTER EVALUATION, Archives of internal medicine, 157(3), 1997, pp. 309-314
Background: Home human immunodeficiency virus (HIV) testing has been p
roposed 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 safe
ty 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 usin
g intent-to-treat analysis. Subjects were provided a home collection k
it (Home Access Health Corp) to collective their own finger-stick bloo
d spot samples for laboratory analysis. Subjects received pretest coun
seling by telephone and their comprehension was subsequently assessed.
Subject-collected blood spot samples were compared with professionall
y drawn blood spot samples for adequacy (sufficient for completing the
Food and Drug Administration-endorsed testing) and with venous sample
s for accuracy. Subjects called 3 days later for anonymous results and
posttest counseling. Device safety was evaluated based on adverse eve
nts 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% sensiti
vity and 100% specificity compared with venous controls. Ninety-eight
percent of subjects obtained testable blood spot specimens compared wi
th phlebotomists. Following pretest counseling, subjects answered 96%
of HIV risk questions correctly. There were no significant adverse eve
nts. Conclusion: Anonymous HIV-1 home collection kits with pretest and
posttest telephone counseling can provide a safe and effective altern
ative to conventional venous HIV-1 antibody testing.