HIV Seronegativity Clinical Trial
Official title:
CCTG 599: Pre-exposure Prophylaxis Accessibility Research and Evaluation (PrEPARE) 2
This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.
All men who have sex with men (MSM) and male-to-female transgender individuals who have sex
with men who present to TNC for HIV testing and are at risk for HIV will be offered
enrollment in this study (see study schema). Upon enrollment, subjects will be given an
Ipad-based computerized questionnaire that assesses their risk perception, demographics, risk
behavior, and perception of whether they are a candidate for PrEP. Upon completion of the
survey they will be randomized into 1 of 2 arms. Subjects in the intervention arm will
receive the results of their risk score based on a risk calculator developed at UCSD and the
Center for Disease Control and Prevention's tool for Assessing Risk for Contracting HIV
(ARCH, formerly known as the HIV Incidence Risk Index for MSM, or HIRI-MSM), whereas subjects
in the control arm will not receive this information. Both groups will receive standard risk
reduction counseling. Subjects will be contacted by phone 2 months after enrollment to
determine whether they initiated PrEP or not, to re-assess their risk perception, and to
provide a link to a final online survey. If subjects have not completed the survey 4 weeks
after being provided with the link, they will receive a text-message reminder.
The analysis of the data will begin 12 weeks after the last study subject is enrolled.
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