Summary

for males ages 18 years and up (full criteria)
healthy people welcome
at San Diego, California
study started
estimated completion:
Jill Blumenthal

Description

Summary

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.

Official Title

CCTG 599: Pre-exposure Prophylaxis Accessibility Research and Evaluation (PrEPARE) 2

Details

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.

Keywords

PrEP Uptake HIV Seronegativity PrEP Risk score Self-perception Informed Risk Score

Eligibility

You can join if…

Open to males ages 18 years and up

  • Man or transgender M to F who has sex with men.
  • Age 18 years or older.
  • Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following: One or more episode of unprotected anal intercourse with a HIV-infected partner or a partner with unknown HIV status within the last 6 months
  • Negative for HIV infection by rapid HIV test

You CAN'T join if...

  • Unable to give informed consent.
  • Signs or symptoms suggestive of acute HIV infection
  • Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Location

  • University of California, San Diego
    San Diego California 92103 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
California Collaborative Treatment Group
ID
NCT02125773
Lead Scientist
Jill Blumenthal
Study Type
Interventional
Last Updated
February 2017