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: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.
Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.
Center on Substance Use and Health
San Francisco, California, United States
Feasibility & Acceptability of CHAMPION
We will calculate the following feasibility and acceptability measures: 1. study completion rate (mean, standard deviation) 2. days of PrEPAPP use (mean, standard deviation) 3. CBT4CBT virtual sessions completed (mean, standard deviation)
Time frame: 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.
Time frame: 6-Months
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