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Enhancing PrEP in Community Settings (EPIC)

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ClinicalTrials.gov Identifier: NCT02371525
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Hektoen Institute for Medical Research
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE February 25, 2015
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing PrEP in Community Settings (EPIC)
Official Title  ICMJE Enhancing PrEP in Community Settings (EPIC)
Brief Summary To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE Behavioral: Prepmate
A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
Study Arms  ICMJE
  • No Intervention: Standard of Care
  • Experimental: Prepmate
    Intervention: Behavioral: Prepmate
Publications * Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
121
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
180
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
  • Interested in initiating PrEP
  • Eligible to initiate PrEP

    • Creatinine clearance > 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
    • Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
    • No other medical contraindications to PrEP
  • Age 18 years - 29 years
  • Willing and able to provide written informed consent
  • Report having had anal sex with a man in the previous 6 months
  • Meet any of the following risk criteria for the prior 6 months:

    • Any condomless anal sex
    • Three or more anal sex partners
    • Self-reported new STI
    • Known HIV-infected sex partner
  • Have regular access to a computer and/or a smart phone to access the internet and/or apps
  • Have the ability to send and receive text messages
  • Able to read and speak in English

Exclusion Criteria:

  • PrEP use within the past year (PrEP naïve participants will be prioritized).
  • Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
  • Prior or current participation in the active arm of an HIV vaccine trial
  • At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
  • Signs or symptoms of acute HIV infection (as described in the SSP Manual)
  • History of pathological bone fracture not related to trauma.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02371525
Other Study ID Numbers  ICMJE 5R01MH095628( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Hektoen Institute for Medical Research
Investigators  ICMJE
Principal Investigator: Albert Liu, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP