Enhancing PrEP in Community Settings (EPIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02371525|
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Prepmate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing PrEP in Community Settings (EPIC)|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
|No Intervention: Standard of Care|
A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
- PrEP adherence among young MSM over time based on dried blood spot (DBS) [ Time Frame: DBS measured through week 36 ]PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.
- Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) [ Time Frame: baseline and week 36 ]Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) at baseline and week 36 (or early termination)
- Change in risk behaviors administered via CASI [ Time Frame: baseline through week 36 ]Change in self-reported sexual risk behavior administered via CASI
- Change in risk perception administered by CASI [ Time Frame: baseline through week 36 ]Changes in risk perception during the study administered by CASI
- Acceptability of Prepmate as measured by an acceptability index collected via CASI [ Time Frame: Month 9 (or early termination) ]Acceptability of Prepmate as measured by an acceptability index collected via CASI at 9 months (or early termination).
- Perceptions of Prepmate provided via individual exit interviews [ Time Frame: Month 10 ]Qualitative feedback provided via individual exit interviews with a subset of participants one month after Prepmate termination. Interviews will be open-ended and will cover topics such as usability, acceptability, user-experience and effectiveness of the Prepmate intervention.
- Patterns of use of Prepmate texting service over time as measured by responses to text messages. [ Time Frame: through week 36 ]Use patterns of Prepmate texting service over time as measured by responses to text messages.
- The incidence of sexually-transmitted infection (STI) among all participants. [ Time Frame: through week 36 ]Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis.
- The number of participants who acquire HIV [ Time Frame: week 36 ]The number of HIV infections (2) The drug resistance profiles of breakthrough infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371525
|United States, Illinois|
|Stroger Hospital and the CORE Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Albert Liu, MD, MPH||University of California, San Francisco|