Contingency Management for PrEP Adherence and/or Methamphetamine Use

NCT04563962 | Completed

• 1 other identifier: IRB#19-001996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Use of crystal methamphetamine (MA) leads to changes in sexual risk behavior, adherence to HIV prevention tools, immune response to infection, and tissue inflammation that collectively increase risk for HIV transmission among MA-using men who have sex with men (MSM), their sexual partners, and their networks. Contingency Management (CM) offers a behavioral modification tool helpful for reducing frequency of MA use, but the effects of CM on the behavioral and biological factors that promote HIV transmission in MSM networks have only been partially evaluated. The intersection of substance use, sexual risk behavior, and HIV transmission in MSM networks presents a critical problem for contemporary HIV prevention as HIV-uninfected MSM who use MA have a 16%-33% greater risk for HIV infection, while only approximately 50% of HIV-infected MA-using MSM achieve and maintain an undetectable viral load. The investigators propose to compare two different CM models to integrate substance use treatment with HIV prevention among MA-using MSM: 1) Traditional CM targeted to MA abstinence and 2) Allternative CM based on ARV adherence.

Conditions

Methamphetamine-dependence; HIV-1-infection

Keywords

Methamphetamine; HIV; Contingency Management

Outcome Measures

Primary Outcomes (2)

• PrEP/ART Adherence

  Proportion of visits in which there are detectable levels of tenofovir in participant urine samples.

  28 days

• Methamphetamine Abstinence

  Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples.

  28 days

Study Arms (2)

Contingency Management-ART

EXPERIMENTAL

Contingency management intervention with incentives tied to provision of urine samples with detectable levels of Tenofovir (TFV).

Behavioral: Contingency Management-ART

Contingency Management-Methamphetamine

ACTIVE COMPARATOR

Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).

Behavioral: Contingency Management-Methamphetamine

Interventions

Contingency Management-ART BEHAVIORAL

Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated adherence to tenofovir-based ART or PrEP.

Contingency Management-ART

Contingency Management-Methamphetamine BEHAVIORAL

Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.

Contingency Management-Methamphetamine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Intervention is designed for men who have sex with men (MSM) and transgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as male or transgender female;
• Report sexual intercourse with a male or transgender female partner in the prior 6 months;
• Report current MA use (at least once per week) with MA present in urine at screening; and
• Taking Truvada or Descovy for PrEP (if HIV-uninfected) or a Tenofovir-based ART regimen (if HIV-infected).

You may not qualify if:

• Inability to understand the study procedures or to provide informed consent
• Not taking a tenofovir-based regimen for HIV prevention or treatment
• Actively seeking treatment for Methamphetamine Use Disorder (MUD)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Location

Study Officials

• Jesse L Clark, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Monica Gandhi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-in-Residence

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 25, 2020
• Study Start: March 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)