Clinical trial NCT02125773: Pre-exposure Prophylaxis Accessibility Research and Evaluation 2
Official title: CCTG 599: Pre-exposure Prophylaxis Accessibility Research and Evaluation (PrEPARE) 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PrEP Uptake
HIV Seronegativity
Keywords: PrEP
Risk score
Self-perception
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: PrEP uptake between informed vs not-informed of risk score
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: CCTG, UCSD AVRC
name: Jill Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: