Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL)

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BACKGROUND: Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression for key populations including those with risky drinking. Gabapentin can decrease alcohol use and thus holds potential for improving medication adherence and HIV viral load suppression for individuals with HIV and risky drinking. METHODS: The aim of this paper is to describe the protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL [Gabapentin to Reduce Alcohol and Improve viral Load suppression]), to test the efficacy of gabapentin versus placebo on achieving undetectable HIV viral load among people with HIV with risky drinking. We will recruit and randomize 220 people with detectable HIV viral loads (≥ 200 copies/ml) and risky drinking. Participants will be randomized 1:1 to receive either gabapentin (1800 mg/day target dose) or placebo for 3 months in a double blind design. Both arms will receive a 5-min evidence-based counseling session aimed at reducing alcohol use. The primary outcome is undetectable viral load (< 200 copies/ml) at 3 months. Other secondary outcomes include undetectable viral load at 6 and 12 months, biomarker-confirmed recent alcohol consumption, antiretroviral therapy (ART) adherence, engagement in HIV care and pain severity. This study will take place in Mbarara, Uganda, as the country ranks among the top five for alcohol consumption globally and has 1.4 million people living with HIV. DISCUSSION: GRAIL tests the efficacy of gabapentin, a medication to decrease alcohol use to achieve HIV viral load suppression. This trial may identify a treatment strategy to prevent the transmission of HIV and improve health outcomes among a high-risk HIV population, specifically those with risky drinking. TRIAL REGISTRATION: This trial has been registered at ClinicalTrials.gov ( NCT05443555 ) on June 29, 2022.

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