HIV/AIDS, Stimulant Use Disorders
Conditions
Keywords
HIV/AIDS, Treatment as Prevention, Methamphetamine, Cocaine, HIV viral Load
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.
Interventions
BEHAVIORALAffect 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).
BEHAVIORALContingency 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
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Viral Load | 15 Months | Log10 HIV viral load change and log10 viral load at 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unsuppressed HIV viral load | 15 Months | Any unsuppressed viral load (\>= 200 copies/mL) over the 15-month follow-up period. |
| T-helper Count | 15 Months | Change in T-helper (CD4+) count |
| Methamphetamine and Cocaine Use (Stimulant Use) | 15 Months | Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up. |
| Psychological Adjustment | 15 Months | Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up. |
| Potentially Amplified Transmission (PAT) Risk Behavior | 15 Months | Changes in self-reported HIV transmission risk behavior with an unsuppressed HIV viral load (\>= 200 copies/mL) over the 15-month follow-up. |
Countries
United States
Outcome results
None listed