Clinical trial NCT02371525: Enhancing PrEP in Community Settings (EPIC)
Official title: Enhancing PrEP in Community Settings (EPIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: adherence
prevention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Hektoen Institute for Medical Research
First posted: 2015-02-25
Enrollment: 121
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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:

  * 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.

Primary outcomes:
measure: PrEP adherence among young MSM over time based on dried blood spot (DBS)
timeFrame: DBS measured through week 36
Secondary outcomes:
measure: Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)
timeFrame: baseline and week 36
measure: Change in risk behaviors administered via CASI
timeFrame: baseline through week 36
measure: Change in risk perception administered by CASI
timeFrame: baseline through week 36
measure: Acceptability of Prepmate as measured by an acceptability index collected via CASI
timeFrame: Month 9 (or early termination)
measure: Perceptions of Prepmate provided via individual exit interviews
timeFrame: Month 10
measure: Patterns of use of Prepmate texting service over time as measured by responses to text messages.
timeFrame: through week 36
measure: The incidence of sexually-transmitted infection (STI) among all participants.
timeFrame: through week 36
measure: The number of participants who acquire HIV
timeFrame: week 36
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Stroger Hospital and the CORE Center
state: Illinois
Study officials:
affiliation: University of California, San Francisco
name: Albert Liu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.