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Pre-exposure Prophylaxis Accessibility Research and Evaluation 2 (CCTG 599)
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Purpose
| Condition | Intervention |
|---|---|
| PrEP Uptake HIV Seronegativity | Behavioral: Informed Risk Score |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Prevention |
| Official Title: | CCTG 599: Pre-exposure Prophylaxis Accessibility Research and Evaluation (PrEPARE) 2 |
- 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
| Estimated Enrollment: | 200 |
| Actual Study Start Date: | April 2014 |
| Estimated Study Completion Date: | July 2017 |
| Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
No Intervention: Control
Subjects in the control arm will not be provided with the results of the risk calculators.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02125773
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Jill Blumenthal, MD | CCTG, UCSD AVRC |
More Information
| Responsible Party: | California Collaborative Treatment Group |
| ClinicalTrials.gov Identifier: | NCT02125773 History of Changes |
| Other Study ID Numbers: |
CCTG 599 |
| Study First Received: | April 25, 2014 |
| Last Updated: | February 24, 2017 |
Keywords provided by California Collaborative Treatment Group:
|
PrEP Risk score Self-perception |
ClinicalTrials.gov processed this record on July 17, 2017