Pre-exposure Prophylaxis Accessibility Research and Evaluation 2

NCT02125773 | Completed

• 1 other identifier: CCTG 599
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Uptake; HIV Seronegativity

Keywords

PrEP; Risk score; Self-perception

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Informed Risk Score

EXPERIMENTAL

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

Control

NO INTERVENTION

Subjects in the control arm will not be provided with the results of the risk calculators.

Interventions

Informed Risk Score BEHAVIORAL

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.

Informed Risk Score

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Study Officials

• Jill Blumenthal, MD

  CCTG, UCSD AVRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: February 19, 2014
• Primary Completion: October 9, 2017
• Study Completion: November 8, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

US (1)