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Contingency Management for PrEP Adherence and/or Methamphetamine Use (C-MAX)

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ClinicalTrials.gov Identifier: NCT04563962
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Methamphetamine-dependence HIV-1-infection Behavioral: Contingency Management-ART Behavioral: Contingency Management-Methamphetamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Contingency Management for PrEP Adherence and/or Methamphetamine UseDisorder Among MSM and TW in Los Angeles: A Pilot Feasibility Study
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contingency Management-ART
Contingency management intervention with incentives tied to provision of urine samples with detectable levels of Tenofovir (TFV).
Behavioral: Contingency Management-ART
Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated adherence to tenofovir-based ART or PrEP.

Active Comparator: Contingency Management-Methamphetamine
Contingency management intervention with incentives tied to provision of urine samples with no detectable levels of methamphetamine (MA).
Behavioral: Contingency Management-Methamphetamine
Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.




Primary Outcome Measures :
  1. PrEP/ART Adherence [ Time Frame: 28 days ]
    Proportion of visits in which there are detectable levels of tenofovir in participant urine samples.

  2. Methamphetamine Abstinence [ Time Frame: 28 days ]
    Proportion of visits in which there are no detectable methamphetamine metabolites in participant urine samples.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Intervention is designed for men who have sex with men (MSM) and transgender women.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion Criteria (for all study components):

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563962


Contacts
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Contact: Jesse L Clark, MD 323-461-3106 jlclark@mednet.ucla.edu

Locations
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United States, California
UCLA Vine Street Clinic Recruiting
Los Angeles, California, United States, 90038
Contact: Christopher Blades    323-461-3106      
Sponsors and Collaborators
University of California, Los Angeles
University of California, San Francisco
Investigators
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Principal Investigator: Jesse L Clark, MD University of California, Los Angeles
Principal Investigator: Monica Gandhi, MD University of California, San Francisco
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Responsible Party: Jesse Clark, Associate Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04563962    
Other Study ID Numbers: IRB#19-001996
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesse Clark, University of California, Los Angeles:
Methamphetamine
HIV
Contingency Management
Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors