HIV Infections Clinical Trial
Official title:
Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).
Approximately 40% of HIV-infected infants in the United States in 2000 were born to women
not diagnosed with their HIV prior to delivery. (1) There are now effective medical
therapies to prevent perinatal transmission, including anti-retroviral therapy, but this
requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control
and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations
for universal HIV-antibody testing of pregnant women.
This will be a randomized controlled, non-inferiority trial comparing two HIV testing
strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH
WHC over the course of approximately one year. Eligible participants will be randomized by
study personnel to either standard HIV counseling and testing (control arm) or abbreviated
counseling and testing (study arm). Participants will receive a standard prenatal HIV
testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an
HIV-1 antibody test, and will follow-up with their medical provider for HIV test results.
Upon completion of counseling, participants will undergo a short, structured (Pre-test)
questionnaire administered by study staff. Following testing and receipt of results,
participants will complete a second (Post-test) structured questionnaire administered by
study staff.
Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited,
consented and randomized by study staff to either the standard or abbreviated testing
strategy. The outcomes studied will be patient satisfaction and the proportion of study
participants who undergo HIV testing. Potential confounder variables to be measured will
include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS,
attitudes towards HIV testing, HIV test result, and type of provider (physician versus
midwife).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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