Gabapentin to reduce alcohol and improve viral load suppression - promoting "treatment as prevention"

Active Project Grant Awarded Last action

Award ID
R01AA030460
Recipient
Awarding agency
Obligated
$5,308,310

Award facts

Assistance listing
93.273 Alcohol Research Programs
Completion date 86% complete
Place of performance
Roxbury, MA 02118, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression for key populations. Unhealthy alcohol use by people with HIV (PWH) is a barrier to reaching HVL suppression at multiple stages of the HIV care cascade. Alcohol use is common among PWH and results in lower antiretroviral therapy (art) adherence and HVL suppression, mitigating the effectiveness of treatment as prevention (tasp), a key strategy for preventing HIV transmission. Treating alcohol use is therefore a mechanism to support PWH with unhealthy alcohol use along the HIV care cascade. In fact, prior studies demonstrate that interventions to reduce alcohol use positively impact HIV outcomes. Gabapentin is efficacious for decreasing alcohol consumption and may be an effective treatment for painful conditions, such as HIV-associated sensory neuropathies. However, gabapentin's role in achieving HVL suppression in this population has not been established. Our hypothesis is that effective pharmacological alcohol treatment (i.e., gabapentin) will help PWH engage in HIV care, adhere to art, and achieve HVL suppression. We propose the gabapentin to reduce alcohol and improve viral load suppression (grail) randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy of gabapentin VS. Placebo to achieve HVL suppression among PWH. The study population will be heavy drinkers with HIV who had a detectable viral load in the past year, despite having been prescribed art. Participants (n=300) will be randomized 1:1 to receive either gabapentin (1800MG/day target dose) or placebo for 3 months; both arms will employ a one-time brief intervention to reduce alcohol use. Grail aims to 1) test the efficacy of gabapentin versus placebo to achieve undetectable HVL at 3 months (primary outcome) and at 6 & 12 months (secondary outcomes); and 2) to assess the impact of gabapentin compared to placebo on: a) alcohol consumption, b) pain severity, c) self-reported art adherence, and d) engagement in HIV care, in order to explore potential mechanisms by which gabapentin may lead to HVL suppression. This study will take place in russia, in a context of syndemic unhealthy alcohol use, drug use, and HIV. Our multi-disciplinary team has an extensive track record of successfully conducting randomized clinical trials in russia, including pharmacological trials (e.g., gabapentin) in PWH. Russia, a setting in which HIV and heavy alcohol use are more prevalent than in the US, will enable efficient study of intervening on alcohol use among PWH. The knowledge gained will be applicable to populations living with HIV in the US and globally. The proposed trial of gabapentin is significant as IT employs a tasp approach to prevent transmission of HIV by targeting alcohol use and achieving HVL suppression. If shown to be effective, this highly generalizable pragmatic approach to tasp can be implemented in a variety of clinical settings, thus making IT a practical addition to the HIV prevention toolkit.

Transactions

Action Obligated Date
Amendment $172,325
Amendment $520,034
Amendment $520,034
Amendment $103,298
Amendment -$103,298
Amendment $125,447
Amendment $550,619
Amendment $646,689
Amendment $648,126
Amendment $648,126
Amendment $738,455
Original award $738,455
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Subawards

Subrecipient Amount Awarded
Mbarara University Of Science And Technology Mbarara University of Science and Technology (MUST), under the direction of Winnie Muyindike, MBChB, MMED, will serve as a subaward to Boston Medical Center,… $172,325
University Of Washington Site PI will serve as Co-Investigator and will assist the team in the study design (including medication dose and adverse events monitoring issues), data… $15,239
The Regents Of The University Of California. San Francisco Site PI will serve as Co-Investigator and will assist the team in the study design, data analysis/interpretation and manuscript preparation. She will also… $25,787
Trustees Of Boston University Biostatistics Dr. Cheng will provide expertise in study design and statistical analyses for this trial assessing the effectiveness of gabapentin to reduce… $114,450
Mbarara University Of Science And Technology Mbarara University of Science and Technology (MUST), under the direction of Winnie Muyindike, MBChB, MMED, will serve as a subaward to Boston Medical Center,… $228,745
Mbarara University Of Science And Technology Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting Treatment as Prevention. $6,212
Mbarara University Of Science And Technology $4,644
University Of Washington Site PI will serve as Co-Investigator and will assist the team in the study design (including medication dose and adverse events monitoring issues), data… $12,409
The Regents Of The University Of California. San Francisco Site PI will serve as Co-Investigator and will assist the team in the study design, data analysis/interpretation and manuscript preparation. She will also… $25,787
Mbarara University Of Science And Technology Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting Treatment as Prevention. $205,616
Mbarara University Of Science And Technology $0
Trustees Of Boston University $117,232
Mbarara University Of Science And Technology Key personnel from MUST will be responsible for overseeing daily activities associated with implementing the study in Uganda, which include: o Enrolling 300… $85,846
The Regents Of The University Of California. San Francisco Dr. Hahn will serve as Co-Investigator and will assist the team in the study design, data analysis/interpretation and manuscript preparation. She will also… $41,513
University Of Washington "Dr. Tsui will serve as Co-Investigator and will assist the team in the study design (including medication dose and adverse events monitoring issues), data… $16,781
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Quick answers

Who received award R01AA030460?

R01AA030460 was awarded to Boston Medical Center Corporation by National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health) on September 20, 2022.

How much is award R01AA030460 worth?

$5,308,310 has been obligated on R01AA030460.

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