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| Name | Class |
|---|---|
| Hektoen Institute for Medical Research | OTHER |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | ||
| Prepmate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepmate | Behavioral | A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support . |
|
| 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 |
| 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 |
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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
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Liu, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroger Hospital and the CORE Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30239620 | Derived | 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. |
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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 |