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RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users (ARTEMIS)

Primary Purpose

HIV/AIDS, Stimulant Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
Contingency Management (CM)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring HIV/AIDS, Treatment as Prevention, Methamphetamine, Cocaine, HIV viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years old
  • Documentation of HIV-positive serostatus
  • Speak English
  • Biological verification of recent methamphetamine use
  • Completion of at least three contingency management (CM) visits
  • Self reported anal sex with a man (MSM) in the past 12 months

Exclusion Criteria:

  • Inability to provide informed consent, evidenced by cognitive impairment
  • HIV negative serostatus

Sites / Locations

  • Alliance Health Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARTEMIS+CM

Attention-Control+CM

Arm Description

This is a 5-session, individually delivered intervention that is designed to enhance positive affect. It is designed to boost and extend the effectiveness of contingency management (CM).

Attention-matched, 5-session control condition consisting of brief-self report psychological measures and neutral writing exercises. Contingency management (CM) is also administered to this arm.

Outcomes

Primary Outcome Measures

HIV Viral Load
Log10 HIV viral load change and log10 viral load at 15 months

Secondary Outcome Measures

Unsuppressed HIV viral load
Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period.
T-helper Count
Change in T-helper (CD4+) count
Methamphetamine and Cocaine Use (Stimulant Use)
Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.
Psychological Adjustment
Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.
Potentially Amplified Transmission (PAT) Risk Behavior
Changes in self-reported HIV transmission risk behavior with an unsuppressed HIV viral load (>= 200 copies/mL) over the 15-month follow-up.

Full Information

First Posted
August 16, 2013
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01926184
Brief Title
RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Acronym
ARTEMIS
Official Title
Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. the team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 110 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. Follow-up data will be collected at 3, 6, 12, and 15 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, unsuppressed viral load, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Stimulant Use Disorders
Keywords
HIV/AIDS, Treatment as Prevention, Methamphetamine, Cocaine, HIV viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARTEMIS+CM
Arm Type
Experimental
Arm Description
This is a 5-session, individually delivered intervention that is designed to enhance positive affect. It is designed to boost and extend the effectiveness of contingency management (CM).
Arm Title
Attention-Control+CM
Arm Type
Placebo Comparator
Arm Description
Attention-matched, 5-session control condition consisting of brief-self report psychological measures and neutral writing exercises. Contingency management (CM) is also administered to this arm.
Intervention Type
Behavioral
Intervention Name(s)
Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
Intervention Description
5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management (CM)
Other Intervention Name(s)
Positive Reinforcement Opportunity Project (PROP)
Intervention Description
12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms
Primary Outcome Measure Information:
Title
HIV Viral Load
Description
Log10 HIV viral load change and log10 viral load at 15 months
Time Frame
15 Months
Secondary Outcome Measure Information:
Title
Unsuppressed HIV viral load
Description
Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period.
Time Frame
15 Months
Title
T-helper Count
Description
Change in T-helper (CD4+) count
Time Frame
15 Months
Title
Methamphetamine and Cocaine Use (Stimulant Use)
Description
Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.
Time Frame
15 Months
Title
Psychological Adjustment
Description
Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.
Time Frame
15 Months
Title
Potentially Amplified Transmission (PAT) Risk Behavior
Description
Changes in self-reported HIV transmission risk behavior with an unsuppressed HIV viral load (>= 200 copies/mL) over the 15-month follow-up.
Time Frame
15 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Documentation of HIV-positive serostatus Speak English Biological verification of recent methamphetamine use Completion of at least three contingency management (CM) visits Self reported anal sex with a man (MSM) in the past 12 months Exclusion Criteria: Inability to provide informed consent, evidenced by cognitive impairment HIV negative serostatus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Woods, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam W. Carrico, Ph.D.
Organizational Affiliation
Miami University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith T. Moskowitz, Ph.D., MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alliance Health Project
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30195243
Citation
Carrico AW, Gomicronmez W, Jain J, Shoptaw S, Discepola MV, Olem D, Lagana-Jackson J, Andrews R, Neilands TB, Dilworth SE, Evans JL, Woods WJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention for methamphetamine users. Drug Alcohol Depend. 2018 Nov 1;192:8-15. doi: 10.1016/j.drugalcdep.2018.07.029. Epub 2018 Sep 5.
Results Reference
derived
PubMed Identifier
27476110
Citation
Carrico AW, Jain J, Discepola MV, Olem D, Andrews R, Woods WJ, Neilands TB, Shoptaw S, Gomez W, Dilworth SE, Moskowitz JT. A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. BMC Public Health. 2016 Jul 30;16:673. doi: 10.1186/s12889-016-3325-1.
Results Reference
derived

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RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users

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