HIV
Conditions
Keywords
adherence, 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).
Interventions
BEHAVIORALPrepmate
A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
Sponsors
Hektoen Institute for Medical Research
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
| 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. |
| The incidence of sexually-transmitted infection (STI) among all participants. | through week 36 | Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis. |
| The number of participants who acquire HIV | week 36 | The number of HIV infections (2) The drug resistance profiles of breakthrough infections |
| 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. |
Countries
United States
Outcome results
None listed