Study Protocol for a Pilot Randomized Trial of a Virtual Occupational Therapy Fall Prevention Intervention for People With HIV and Alcohol Use

Background:People living with HIV (PLWH) are at risk for falls due to polypharmacy, unhealthy substance (risky alcohol and/or illicit drug) use, low physical activity, and frailty combined with typical age-related physical changes. Fall prevention is needed to reduce the morbidity related to falls and fractures, however, there is a paucity of data on the design of a fall prevention intervention and whether it can be delivered virtually. We describe the protocol of a pilot randomized trial of a virtual occupational therapy fall prevention intervention for people with HIV at high risk for falls and recent alcohol and/or drug use. Method:PLWH will be recruited from the Boston ARCH 4F Cohort study, an observational study of PLWH to examine the impact of alcohol on falls. Trial participants will be randomized to either an occupational therapy-led fall prevention intervention or provided with written education about fall prevention and alcohol use (control). The 10-week fall prevention intervention was based upon results from qualitative interviews with PLWH about falls and will consist of weekly virtual group sessions, home exercises and phone-check-ins, delivered by occupational therapists. The primary outcome measures will be number of groups attended and a participant-completed satisfaction survey. Change in number of falls, alcohol and other drug use, and physical functioning will be examined. Discussion:A virtual occupational therapy fall prevention intervention addresses the emerging concern of fall risk in PLWH and alcohol use. This pilot study will provide preliminary estimates of fall-related outcomes as well as feasibility of study procedures for a larger trial. ClinicalTrials.gov Identifier:NCT04804579. Boston University Protocol Record H-41041