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Not yet recruiting NCT07213258

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

No phase Interventional PrEP Adherence Methamphetamine Use Disorder HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHAMPION Intervention, Delayed CHAMPION Package.
Who it may be relevant to
Registry conditions: PrEP Adherence, Methamphetamine Use Disorder, HIV. Basic parameters: 18 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Behavioral CHAMPION Intervention
    MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.
  • Behavioral Delayed CHAMPION Package
    Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.

Primary outcome measures

  • Feasibility & Acceptability of CHAMPION [Time frame: 6 months]
  • PrEP adherence [Time frame: 6-Months]

Eligibility criteria

Inclusion criteria

  • HIV-negative
  • Cis-gender male
  • Age 18-40 years old
  • Mild or moderate MUD (by DSM-5 SCID criteria)
  • Anal intercourse with one or more male partners in the past 6 months
  • Started daily oral PrEP more than 30 days ago and self-reported not always taking PrEP as prescribed in the past 30 days (consistent with PrEP It! inclusion criteria)
  • Willingness to participate in an mHealth study with a 6-month follow-up
  • Residing in San Diego or San Francisco County

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Center on Substance Use and Health — San Francisco

Identifiers

NCT: NCT07213258 · R21DA060856 · R21DA060856

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗