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NCT Number: NCT07213258

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center on Substance Use and Health

San Francisco, California, 94102, United States

Location contact

Glenn-Milo Santos

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility & Acceptability of CHAMPION

    Time frame: 6 months

    We will calculate the following feasibility and acceptability measures:

    • study completion rate (mean, standard deviation)
    • days of PrEPAPP use (mean, standard deviation)
    • CBT4CBT virtual sessions completed (mean, standard deviation)
  2. PrEP adherence

    Time frame: 6-Months

    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.

Other outcomes

  1. Meth use

    Time frame: 6 months

    Explored through monthly self-reported data on the CHAMPION App (intervention arm). We will calculate the following outcome:

    • Days of meth use in the past month (mean, standard deviation)
  2. Sexual risk behavior

    Time frame: 6 months

    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:

    • number of sex partners (mean, standard deviation)
    • number of sex partners with whom meth are used (mean, standard deviation)
    • episodes of condomless sex with serodiscordant partners (mean, standard deviation)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandrea Dunham, B.A.

CONTACT

[email protected]

530-925-3398

Glenn-Milo Santos, PhD, MPH

CONTACT

[email protected]

628-217-6231

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco

Registry information

Acronym: CHAMPION

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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