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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
California Collaborative Treatment Group
ClinicalTrials.gov Identifier:
NCT02125773
First received: April 25, 2014
Last updated: February 24, 2017
Last verified: February 2017
History of Changes
April 25, 2014
February 24, 2017
April 2014
September 2016   (Final data collection date for primary outcome measure)
PrEP uptake between informed vs not-informed of risk score [ Time Frame: 12 Weeks ]
To compare the proportion of subjects that initiate PrEP between subjects who were informed of their calculated HIV risk score to that of subjects who were not informed of their calculated risk score
Same as current
Complete list of historical versions of study NCT02125773 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pre-exposure Prophylaxis Accessibility Research and Evaluation 2
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
  • PrEP Uptake
  • HIV Seronegativity
Behavioral: Informed Risk Score
Subjects in the intervention arm will receive an estimate of their risk of HIV infection as estimated by the UCSD calculator. The risk of HIV infection will be based on the subject's responses to the self-reported sexual risk questionnaire and the risk of HIV infection in one year will be extrapolated based on continuation of the same risk behavior. The subjects will also be provided the calculated risk if they were to take PrEP. Subjects in the control arm will not be provided with the results of the risk calculators. Both arms will receive standard of care risk reduction education and information sheets about PrEP.
  • Experimental: Informed Risk Score
    Subjects in the intervention arm will receive an estimate of their risk of HIV infection as estimated by the UCSD calculator.
    Intervention: Behavioral: Informed Risk Score
  • No Intervention: Control
    Subjects in the control arm will not be provided with the results of the risk calculators.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
July 2017
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02125773
CCTG 599
No
Not Provided
Not Provided
California Collaborative Treatment Group
California Collaborative Treatment Group
University of California, San Diego
Principal Investigator: Jill Blumenthal, MD CCTG, UCSD AVRC
California Collaborative Treatment Group
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP