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)

Abstract 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: To describe the protocol for arandomized, 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 recruit and randomize 300 people with detectable HIV viral loads (>= 200 copies/ml) and risky drinking. Participants are randomized 1:1 to receive either gabapentin (1800 mg/day target dose) or placebo for 3 months in a double blind design. Both arms receive a 5-minute 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 takes 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. clinicaltrials.gov