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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA060856 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, San Francisco | OTHER |
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The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are:
The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHAMPION Intervention Arm | Experimental | mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period. |
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| Waitlist Control Arm | Other | 3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHAMPION Intervention | Behavioral | MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility & Acceptability of CHAMPION | We will calculate the following feasibility and acceptability measures:
| 6 months |
| PrEP adherence | We will examine the preliminary efficacy of CHAMPION vs. a waitlist control on increasing PrEP adherence, compared to a waitlist control as determined by dried blood spot (DBS) tests. In preparation for a larger efficacy trial, we will explore the preliminary efficacy of CHAMPION vs. waitlist control in increasing PrEP adherence. PrEP drug levels in DBS samples will be dichotomized as PrEP adherence, or not, using established cut-offs for protective levels of PrEP. We will calculate the following outcome measure: 1.) Number and percent adherent to PrEP, based on DBS. | 6-Months |
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| Measure | Description | Time Frame |
|---|---|---|
| Meth use | Explored through monthly self-reported data on the CHAMPION App (intervention arm). We will calculate the following outcome: 1) Days of meth use in the past month (mean, standard deviation) | 6 months |
| Sexual risk behavior |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glenn-Milo Santos, PhD, MPH | Contact | 628-217-6231 | glenn-milo.santos@ucsf.edu | |
| Alexandrea Dunham, B.A. | Contact | 530-925-3398 | allie.dunham@sfdph.org |
| Name | Affiliation | Role |
|---|---|---|
| Glenn-Milo Santos, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Kiyomi Tsuyuki, PhD, MPH | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Substance Use and Health | San Francisco | California | 94102 | United States |
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| Delayed CHAMPION Package | Behavioral | Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months. |
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To determine the preliminary efficacy in reducing sexual risk behaviors, we will use GEE Poisson, binomial and negative binomial models with robust standard errors to assess evidence that the intervention reduces HIV risk behaviors. We will calculate the following outcomes:
| 6 months |