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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

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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: Prepmate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
No Intervention: Standard of Care
Experimental: Prepmate Behavioral: Prepmate
A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Change in risk behaviors administered via CASI [ Time Frame: baseline through week 36 ]
    Change in self-reported sexual risk behavior administered via CASI

  3. Change in risk perception administered by CASI [ Time Frame: baseline through week 36 ]
    Changes in risk perception during the study administered by CASI

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. The number of participants who acquire HIV [ Time Frame: week 36 ]
    The number of HIV infections (2) The drug resistance profiles of breakthrough infections



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Stroger Hospital and the CORE Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of California, San Francisco
Hektoen Institute for Medical Research
Investigators
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Principal Investigator: Albert Liu, MD, MPH University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02371525     History of Changes
Other Study ID Numbers: 5R01MH095628 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of California, San Francisco:
adherence
prevention