Pre-exposure Prophylaxis Accessibility Research and Evaluation 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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PrEP Uptake, HIV Seronegativity

Intervention / Treatment
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* Behavioral: Informed Risk Score


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Informed Risk Score<br>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<br>* 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.<br>|
| No Intervention: Control<br>Subjects in the control arm will not be provided with the results of the risk calculators. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake between informed vs not-informed of risk score | 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 | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Risk score, Self-perception