Enhancing PrEP in Community Settings (EPIC)

Study Overview
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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).

Official Title
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Enhancing PrEP in Community Settings (EPIC)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Prepmate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br> | |
| Experimental: Prepmate<br> | Behavioral: Prepmate<br>* A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in risk behaviors administered via CASI | Change in self-reported sexual risk behavior administered via CASI | baseline through week 36 | 
| Change in risk perception administered by CASI | Changes in risk perception during the study administered by CASI | baseline through week 36 | 
| 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) | 
| 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 | 
| 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 | 
| The incidence of sexually-transmitted infection (STI) among all participants. | Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis. | through week 36 | 
| The number of participants who acquire HIV | The number of HIV infections (2) The drug resistance profiles of breakthrough infections | week 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, prevention