Enhancing PrEP in Community Settings (EPIC)

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Prepmate

• Registration Number: NCT02371525
• Lead Sponsor: University of California, San Francisco

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Study Start: 2015-04
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prepmate	Prepmate	-

Primary Outcome Measures

Name	Time	Method
PrEP adherence among young MSM over time based on dried blood spot (DBS)	DBS measured through week 36	PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.

Secondary Outcome Measures

Name	Time	Method
Patterns of use of Prepmate texting service over time as measured by responses to text messages.	through week 36	Use patterns of Prepmate texting service over time as measured by responses to text messages.
Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)	baseline and week 36	Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) at baseline and week 36 (or early termination)
Perceptions of Prepmate provided via individual exit interviews	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.
The incidence of sexually-transmitted infection (STI) among all participants.	through week 36	Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis.
Change in risk behaviors administered via CASI	baseline through week 36	Change in self-reported sexual risk behavior administered via CASI
Change in risk perception administered by CASI	baseline through week 36	Changes in risk perception during the study administered by CASI
Acceptability of Prepmate as measured by an acceptability index collected via CASI	Month 9 (or early termination)	Acceptability of Prepmate as measured by an acceptability index collected via CASI at 9 months (or early termination).
The number of participants who acquire HIV	week 36	The number of HIV infections (2) The drug resistance profiles of breakthrough infections

Trial Locations

Locations (1)

Stroger Hospital and the CORE Center; 🇺🇸 Chicago, Illinois, United States