Enhancing PrEP in Community Settings (EPIC)

University of California, San Francisco1 site in 1 country121 target enrollmentApril 2015

ConditionsHIV

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV
Sponsor: University of California, San Francisco
Enrollment: 121
Locations: 1
Primary Endpoint: PrEP adherence among young MSM over time based on dried blood spot (DBS)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

January 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of California, San Francisco

Responsible Party

Sponsor

Eligibility 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:

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.

Outcomes

Primary Outcomes

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

Patterns of use of Prepmate texting service over time as measured by responses to text messages.(through week 36)
Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)(baseline and week 36)
Perceptions of Prepmate provided via individual exit interviews(Month 10)
The incidence of sexually-transmitted infection (STI) among all participants.(through week 36)
Change in risk behaviors administered via CASI(baseline through week 36)
Change in risk perception administered by CASI(baseline through week 36)
Acceptability of Prepmate as measured by an acceptability index collected via CASI(Month 9 (or early termination))
The number of participants who acquire HIV(week 36)