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OpenTrials
Completed

NCT Number: NCT02371525

Enhancing PrEP in Community Settings (EPIC)

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).

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Key information

Conditions

HIV

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stroger Hospital and the CORE Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prepmate

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Hektoen Institute for Medical Research

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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