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

NCT ID: NCT07213258

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2026-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PrEP Adherence Methamphetamine Use Disorder HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHAMPION Intervention Arm

mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period.

Group Type EXPERIMENTAL

CHAMPION Intervention

Intervention Type BEHAVIORAL

MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.

Waitlist Control Arm

3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.

Group Type OTHER

Delayed CHAMPION Package

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHAMPION Intervention

MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.

Intervention Type BEHAVIORAL

Delayed CHAMPION Package

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. HIV-negative
2. Cis-gender male
3. Age 18-40 years old
4. Mild or moderate MUD (by DSM-5 SCID criteria)
5. Anal intercourse with one or more male partners in the past 6 months
7. Willingness to participate in an mHealth study with a 6-month follow-up
8. Residing in San Diego or San Francisco County

Exclusion Criteria

1. Residing outside of San Diego or San Francisco County
2. Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures
3. Not able/willing to complete virtual/remote visits
4. Not willing to learn to self-collect dried blood spots using a finger stick
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kiyomi Tsuyuki

Multi-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Glenn-Milo Santos, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kiyomi Tsuyuki, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center on Substance Use and Health

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Glenn-Milo Santos, PhD, MPH

Role: CONTACT

628-217-6231

Alexandrea Dunham, B.A.

Role: CONTACT

530-925-3398

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Glenn-Milo Santos

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21DA060856

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21DA060856

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stonewall Treatment Evaluation Project
NCT01129401 COMPLETED PHASE1/PHASE2
PrEP Affect Regulation Treatment Innovation
NCT04899024 ACTIVE_NOT_RECRUITING NA
Inflammation in Methamphetamine and STIs (IMSTI)
NCT05162391 ACTIVE_NOT_RECRUITING NA
Development of a Methamphetamine Early Intervention
NCT01174654 COMPLETED PHASE1/PHASE2
Study Targeting Affect Regulation
NCT01237366 COMPLETED PHASE1/PHASE2