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CompletedNCT02371525Updated Oct 26, 2017

Enhancing PrEP in Community Settings (EPIC)

An interventional study of Prepmate in HIV, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
Male
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Study 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).

02

Conditions studied

  • HIV

Keywords

  • adherence
  • prevention
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In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
121 participants (actual)

Study arms

  • No intervention
    Standard of Care
  • Experimental
    Prepmate

    Behavioral: Prepmate

Interventions

  • BehavioralPrepmate

    A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .

06

What researchers measure

Primary outcomes

  1. PrEP adherence among young MSM over time based on dried blood spot (DBS)

    PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.

    Time frame: DBS measured through week 36

Secondary outcomes

  1. Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)

    Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) at baseline and week 36 (or early termination)

    Time frame: baseline and week 36

  2. Change in risk behaviors administered via CASI

    Change in self-reported sexual risk behavior administered via CASI

    Time frame: baseline through week 36

  3. Change in risk perception administered by CASI

    Changes in risk perception during the study administered by CASI

    Time frame: baseline through week 36

  4. Acceptability of Prepmate as measured by an acceptability index collected via CASI

    Acceptability of Prepmate as measured by an acceptability index collected via CASI at 9 months (or early termination).

    Time frame: Month 9 (or early termination)

  5. Perceptions of Prepmate provided via individual exit interviews

    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.

    Time frame: Month 10

  6. Patterns of use of Prepmate texting service over time as measured by responses to text messages.

    Use patterns of Prepmate texting service over time as measured by responses to text messages.

    Time frame: through week 36

  7. The incidence of sexually-transmitted infection (STI) among all participants.

    Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis.

    Time frame: through week 36

  8. The number of participants who acquire HIV

    The number of HIV infections (2) The drug resistance profiles of breakthrough infections

    Time frame: week 36

07

Study locations

1 site
  • Stroger Hospital and the CORE Center
    Chicago, Illinois 60612, United States
08

References and documents

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. PubMed 30239620 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02371525
Lead sponsor
University of California, San Francisco
Collaborators
Hektoen Institute for Medical Research
Responsible party
Sponsor
First posted
Feb 25, 2015
Start date
Apr 2015
Primary completion
Nov 2016
Completion
Jan 2017
Last update
Oct 26, 2017

Study contacts

Albert Liu, MD, MPH
principal investigator · University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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