BACKGROUND: Persons with HIV have an increased risk of cardiovascular and metabolic diseases compared to HIV serostatus-negative individuals. OBJECTIVE: We conducted a pilot wait-list control randomized trial to assess the feasibility and acceptability of a virtual environment for CVD and metabolic disease prevention education in men living with HIV. METHODS: In phase one, we conducted interviews and virtual environment beta testing with (n=25) individuals. In phase two, reported here, we conducted a wait-list control trial with permuted block randomization. Participants were allocated to the virtual environment intervention (n = 40) or a wait-list control arm (n = 38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) with virtual environment. We also examined preliminary effect sizes across several cardiovascular health-related indicators. RESULTS: Participants had a mean age of 41.8 years (SD=10.4) and had been living with HIV for an average of 15.9 years (SD=9.7). Participants were 62.5% Black and 26.7% Hispanic. A total of 45.0% of the intervention arm engaged with the virtual environment, with an average session duration of 110 minutes. The most engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 61.5% at final assessment, which to our knowledge, is notably higher than the typical retention rates seen in remote digital health research and all behavioral intervention research. Preliminary efficacy analyses across 3- and 6-month changes revealed medium effect sizes favoring the intervention for key nutritional outcomes (vegetable consumption: d=0.59-0.66; whole grain intake: d=0.41-0.46); and vigorous physical activity (d=0.38-0.57). Small-to-medium effect sizes were observed for fast food reduction (d=0.37 at 6-months), total physical activity (d=0.37 at 6-months), and depressive symptoms (d=0.22 at 3-months), as well as HIV illness perceptions, including timeline acute/chronic (d=0.44 at 3-months), illness coherence (d=0.33 at 3-months), and emotional representations (d=0.23-0.33). CONCLUSIONS: The LEARN Study demonstrated the feasibility and acceptability of a virtual environment designed for cardiovascular and metabolic disease prevention education in persons with HIV. The high engagement rates with specific educational content and strong retention highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating further potential benefits of the intervention. These findings support progression to a fully powered randomized controlled trial. Subsequent funding has been awarded, based on this work, to expand the research in LEARN2. We will integrate lessons learned and focus on HIV- related conditions with shared risk factors to enhance the study's impact. By addressing HIV conditions with interrelated risk factors, we aim to provide a more comprehensive intervention to improve the overall health and well-being of individuals living with HIV. CLINICALTRIAL: ClinicalTrials.gov NCT05242952. INTERNATIONAL REGISTERED REPORT: RR2-10.2196/38348.
Ramos et al. (Fri,) studied this question.