Anonymous HIV testing using home collection and telemedicine counseling. A multicenter evaluation.
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.


CONCLUSIONS
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.
Frank
A P
AP
Department of Medicine, Illinois Masonic Medical Center, Chicago, USA.
Wandell
M G
MG
Headings
M D
MD
Conant
M A
MA
Woody
G E
GE
Michel
C
C
D000328:Adult; D035041:Anonymous Testing; D001800:Blood Specimen Collection / Q000379:methods*; D032882:Comprehension; D003219:Confidentiality; D003376:Counseling; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D006679:HIV Seropositivity / Q000175:diagnosis* / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006699:Home Care Services; D006801:Humans; D008297:Male; D008875:Middle Aged; D015397:Program Evaluation; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012307:Risk Factors; D012648:Self Care; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D017216:Telemedicine
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic