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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA033854 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Viral Load | Log10 HIV viral load change and log10 viral load at 15 months | 15 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Unsuppressed HIV viral load | Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period. | 15 Months |
| T-helper Count | Change in T-helper (CD4+) count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Health Project | San Francisco | California | 94102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39315986 | Derived | 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. | |
| 30195243 | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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 |
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| 15 Months |
| 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 |
| Psychological Adjustment | Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up. | 15 Months |
| 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 |
| 27476110 | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |