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

NCT01926184 | Completed DMC

• 1 other identifier: R01DA033854
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Stimulant Use Disorders

Keywords

HIV/AIDS; Treatment as Prevention; Methamphetamine; Cocaine; HIV viral Load

Outcome Measures

Primary Outcomes (1)

• HIV Viral Load

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

  15 Months

Secondary Outcomes (5)

• Unsuppressed HIV viral load

  15 Months

• T-helper Count

  15 Months

• Methamphetamine and Cocaine Use (Stimulant Use)

  15 Months

• Psychological Adjustment

  15 Months

• Potentially Amplified Transmission (PAT) Risk Behavior

  15 Months

Study Arms (2)

ARTEMIS+CM

EXPERIMENTAL

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).

Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS); Behavioral: Contingency Management (CM)

Attention-Control+CM

PLACEBO COMPARATOR

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.

Behavioral: Contingency Management (CM)

Interventions

Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) BEHAVIORAL

5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).

ARTEMIS+CM

Contingency Management (CM) BEHAVIORAL

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

Also known as: Positive Reinforcement Opportunity Project (PROP)

ARTEMIS+CM; Attention-Control+CM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Alliance Health Project

San Francisco, California, 94102, United States

Location

Related Publications (3)

• Foley J, Batchelder AW, Bernier L, Glynn T, Moskowitz J, Carrico A. Facets of mindfulness are associated with inflammation biomarkers in a sample of sexual minority men with HIV. Psychol Health Med. 2025 Feb;30(2):368-383. doi: 10.1080/13548506.2024.2407445. Epub 2024 Sep 24.

  PMID: 39315986 DERIVED

• 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.

  PMID: 30195243 DERIVED

• 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.

  PMID: 27476110 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• William Woods, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Adam W. Carrico, Ph.D.

  Miami University

  PRINCIPAL INVESTIGATOR

• Judith T. Moskowitz, Ph.D., MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: January 1, 2013
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)