Enhancing PrEP in Community Settings (EPIC)

October 24, 2017 updated by: University of California, San Francisco
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
DBS measured through week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and week 36
Change in risk behaviors administered via CASI
Time Frame: baseline through week 36
Change in self-reported sexual risk behavior administered via CASI
baseline through week 36
Change in risk perception administered by CASI
Time Frame: baseline through week 36
Changes in risk perception during the study administered by CASI
baseline through week 36
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).
Month 9 (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.
Month 10
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.
through week 36
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.
through week 36
The number of participants who acquire HIV
Time Frame: week 36
The number of HIV infections (2) The drug resistance profiles of breakthrough infections
week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Hektoen Institute for Medical Research

Investigators

  • Principal Investigator: Albert Liu, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R01MH095628 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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