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

University of California San Diego

Status: Not yet enrolling

Conditions: Methamphetamine Use Disorder; PrEP Adherence; HIV

Treatments: Behavioral: Delayed CHAMPION Package; Behavioral: CHAMPION Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07213258

R21DA060856 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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
6. 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)
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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CHAMPION Intervention Arm

Experimental group

Description:

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

Treatment:

Behavioral: CHAMPION Intervention

Waitlist Control Arm

Other group

Description:

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

Treatment:

Behavioral: Delayed CHAMPION Package