Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking.

Background: Among people living with HIV (PLWH), unhealthy drinking presents an increased risk for negative outcomes. Physical inactivity and sedentariness raise additional health risks. Despite evidence that physical activity (PA) is associated with improved physical and mental functioning and reduced alcohol cravings, there have been no PA studies conducted with PLWH engaged in unhealthy drinking. We describe a study protocol of a remote lifestyle physical activity (LPA) intervention to increase PA and reduce alcohol consumption among PLWH.

Methods: Using online advertisements, 220 low-active PLWH engaged in unhealthy drinking will be recruited and randomized nationwide. After providing informed consent and completing a baseline interview, participants will receive a Fitbit. Participants will complete 15 days of ecologic momentary assessment through a phone application and up to 15 days of Fitbit wear time. Following this period, participants will be randomly assigned to a Fitbit-only control condition or a LPA and Fitbit intervention condition. Health counselors meet with control participants once (and have 6 subsequent brief check ins on Fibit use) and with intervention participants 7 times for PA counseling over a 12-week period. Follow-up assessments will be conducted at 3- and 6-months post-randomization. We hypothesize that individuals in the LPA and Fitbit condition will have lower rates of alcohol consumption and higher rates of PA at 6-month follow-up.

Conclusion: The randomized controlled trial described in this paper investigates remote methods to influence multimorbidity among PLWH using a LPA approach for increasing PA and reducing alcohol consumption.