Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting Treatment as Prevention
GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at least 6 months after their HIV diagnosis. This trial aims to test the efficacy of gabapentin versus placebo to achieve undetectable HVL and assess the impact of gabapentin compared to placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care. HIV viral load will be assessed at 3 (primary), 6 and 12 months via laboratory test. Eligible participants will be randomly assigned into one of two study arms: 1) gabapentin (1800mg/day target dose) for 3 months vs. 2) placebo for 3 months. All participants will receive evidence-based counseling for alcohol and either an active medication or placebo.
• Having an HIV diagnosis for at least 6 months
• Current (within 2 months) detectable HIV viral load at least 6 months after HIV diagnosis
• Positive EtG urine test
• Able and willing to comply with all study protocols and procedures
• Living within 2 hours travel time of the study site