Chicago, Illinois 60612

  • HIV

Purpose:

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).


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.


Study is Available At:


Original ID:

5R01MH095628


NCT ID:

NCT02371525


Secondary ID:


Study Acronym:


Brief Title:

Enhancing PrEP in Community Settings (EPIC)


Official Title:

Enhancing PrEP in Community Settings (EPIC)


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

29 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

  • United States: National Institute of Mental Health
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

121


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:April 2015
Completion Date:January 2017
Completion Type:Actual
Primary Completion Date:November 2016
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 24, 2017
First Received Date:February 19, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The number of participants who acquire HIV
Time Frame:week 36
Safety Issues:False
Description:The number of HIV infections (2) The drug resistance profiles of breakthrough infections
Outcome Type:Secondary Outcome
Measure:The incidence of sexually-transmitted infection (STI) among all participants.
Time Frame:through week 36
Safety Issues:False
Description:Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis.
Outcome Type:Secondary Outcome
Measure:Patterns of use of Prepmate texting service over time as measured by responses to text messages.
Time Frame:through week 36
Safety Issues:False
Description:Use patterns of Prepmate texting service over time as measured by responses to text messages.
Outcome Type:Secondary Outcome
Measure:Perceptions of Prepmate provided via individual exit interviews
Time Frame:Month 10
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Acceptability of Prepmate as measured by an acceptability index collected via CASI
Time Frame:Month 9 (or early termination)
Safety Issues:False
Description:Acceptability of Prepmate as measured by an acceptability index collected via CASI at 9 months (or early termination).
Outcome Type:Secondary Outcome
Measure:Change in risk perception administered by CASI
Time Frame:baseline through week 36
Safety Issues:False
Description:Changes in risk perception during the study administered by CASI
Outcome Type:Secondary Outcome
Measure:Change in risk behaviors administered via CASI
Time Frame:baseline through week 36
Safety Issues:False
Description:Change in self-reported sexual risk behavior administered via CASI
Outcome Type:Secondary Outcome
Measure:Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)
Time Frame:baseline and week 36
Safety Issues:False
Description:Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) at baseline and week 36 (or early termination)
Outcome Type:Primary Outcome
Measure:PrEP adherence among young MSM over time based on dried blood spot (DBS)
Time Frame:DBS measured through week 36
Safety Issues:False
Description:PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.

Study Interventions

Intervention Type:Behavioral
Name:Prepmate
Description:A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
Arm Name:Prepmate

Study Arms

Study Arm Type:Experimental
Arm Name:Prepmate
Study Arm Type:No Intervention
Arm Name:Standard of Care

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:Other
Agency Type:Collaborator
Agency Name:Hektoen Institute for Medical Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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