Enhancing PrEP in Community Settings (EPIC)

HIV Clinical Trial

Official title:

Enhancing PrEP in Community Settings (EPIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371525
• Other study ID #: 5R01MH095628
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: October 24, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Stroger Hospital and the CORE Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Hektoen Institute for Medical Research

Country where clinical trial is conducted

United States, 

Outcome

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