Pre-exposure Prophylaxis Accessibility Research and Evaluation 2
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | July 2016 |
| Contact: | Jill Blumenthal, MD |
| Email: | jblumenthal@ucsd.edu |
| Phone: | 619-543-8080 |
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.
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.
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.
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.
We found this trial at
1
site
San Diego, California 92093
Principal Investigator: Jill Blumenthal, MD
Phone: 619-543-8080
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