Enhancing PrEP in Community Settings (EPIC)

NCT ID: NCT02371525

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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HIV

Keywords

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adherence prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Prepmate

Group Type EXPERIMENTAL

Prepmate

Intervention Type BEHAVIORAL

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

Interventions

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Prepmate

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hektoen Institute for Medical Research

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Liu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Stroger Hospital and the CORE Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30239620 (View on PubMed)

Other Identifiers

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5R01MH095628

Identifier Type: NIH

Identifier Source: org_study_id

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