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

HIV/AIDS Clinical Trial

— ARTEMIS  

Official title:

Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926184
• Other study ID #: R01DA033854
• Secondary ID: R01DA033854
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 8, 2018

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Stimulant Use Disorders

Intervention

Behavioral:
• Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).
• Contingency Management (CM)
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

Locations

Country	Name	City	State
United States	Alliance Health Project	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Viral Load	Log10 HIV viral load change and log10 viral load at 15 months	15 Months
Secondary	Unsuppressed HIV viral load	Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period.	15 Months
Secondary	T-helper Count	Change in T-helper (CD4+) count	15 Months
Secondary	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.	15 Months
Secondary	Psychological Adjustment	Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.	15 Months
Secondary	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.	15 Months