A Web-Based Virtual Environment Behavioral Intervention as Cardiovascular Disease and Metabolic Disease Prevention Education in Persons With HIV: Evaluation of the LEARN Randomized Controlled Trial.

backgroundPersons living with HIV have an increased risk of cardiovascular and metabolic diseases compared with HIV-seronegative individuals.

objectiveThis study aims to assess the feasibility and acceptability of a virtual environment (VE) for cardiovascular disease and metabolic disease prevention education among men living with HIV through a pilot waitlist-control randomized trial.

methodsIn phase 1, we conducted interviews and VE beta testing with 25 individuals. In phase 2, reported here, we conducted a waitlist-controlled trial using permuted block randomization. Participants were allocated to either the VE intervention (n=40) or the waitlist control arm (n=38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) of the VE. We also examined preliminary effect sizes across several cardiovascular health-related indicators.

resultsParticipants had a mean age of 41.8 (SD 10.4) years and had been living with HIV for a mean of 15.9 (SD 9.7) years. Of the 56 total participants, 35 (63%) were Black and 15 (27%) were Hispanic. A total of 14 out of 31 (45%) of participants with baseline data in the intervention arm engaged with the VE, with an average session duration of 110 minutes. The most highly engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 48 out of 78 (61%) at the final assessment, which, to our knowledge, is higher than the typical retention rates reported in remote digital health and behavioral intervention research. Preliminary efficacy analyses of changes at 3 and 6 months 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), depressive symptoms (d=0.22 at 3 months), and HIV illness perceptions, including Timeline Acute/Chronic subscale score (d=0.44 at 3 months), Illness Coherence (d=0.33 at 3 months), and Emotional Representations (d=0.23-0.33).

conclusionsThe LEARN (LEveraging A viRtual eNvironment to enhance prevention of HIV-related comorbidities) study demonstrated the feasibility and acceptability of a VE designed for cardiovascular and metabolic disease prevention education among persons living with HIV. High engagement with specific educational content and favorable retention rates highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating the potential for additional benefits associated with 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 from this study and focus on HIV-related conditions with shared risk factors to enhance the intervention's impact. By addressing HIV-related 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.

trial registrationClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/38348.