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CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM

ConditionsPrEP AdherenceMethamphetamine Use DisorderHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-40
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV-negative

Cis-gender male

Age 18-40 years old

Mild or moderate MUD (by DSM-5 SCID criteria)

Disqualifiers

Residing outside of San Diego or San Francisco County

Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures

Not able/willing to complete virtual/remote visits

Not willing to learn to self-collect dried blood spots using a finger stick

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Delayed CHAMPION Package

    Behavioral

    Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CHAMPION Intervention ArmExperimental treatment 1 intervention
Group B: Waitlist Control ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

1

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)

Time frame
6 months
2

Sexual risk behavior

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: 1. number of sex partners (mean, standard deviation) 2. number of sex partners with whom meth are used (mean, standard deviation) 3. episodes of condomless sex with serodiscordant partners (mean, standard deviation)

Time frame
6 months

Sponsors and contacts

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University of California, San Diego

Lead sponsor

University of California, San Francisco

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

University of California, San Francisco

Collaborator

Source ClinicalTrials.gov
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