Tackling cardiovascular risk factors in Swiss people living with HIV using the “Trials Within Cohort” design
Description: Background: Substantial improvements in antiretroviral therapy in recent decades has allowed people living with HIV (PLHIV) in Switzerland to have a life expectancy similar to the general population. However, in addition to the age and lifestyle related increased risk of cardiovascular diseases, this population faces additional cardiovascular risks due to a chronic inflammatory state and effects of antiretroviral medication. Given this high-risk constellation in PLHIV, the modification of cardiovascular risk factors and thus the prevention of cardiovascular disease morbidity and mortality become crucial.Aim: We aim to investigate the effects of two pragmatic lifestyle interventions to improve the cardiovascular risk profile of PLHIV. Design: Two randomized controlled “Trials within a Cohort” integrated into the Swiss HIV Cohort Study. Project A: RETUNE-HIV: We will assess the effectiveness of offering preference-based smoking cessation (nicotine replacement therapy, e-cigarettes, or nicotine pouches) combined with counselling versus counselling alone (usual care) on smoking cessation rates in PLHIV. The primary endpoint will be smoking cessation measured as self-reported 7-day point prevalence abstinence from baseline to 6 months. We will include all smokers in the Swiss HIV Cohort Study and use logistic regression to analyze the data following the intention to treat principle. Project B: IMPACT-HIV: We will assess the effectiveness of offering a smartphone-based multicomponent lifestyle intervention (physical activity and diet modification) versus usual care on the reduction of overweight in PLHIV. The primary endpoint will be the mean change in waist-height-ratio from baseline to 6 months. We will include all people in the Swiss HIV Cohort Study with a Body-Mass-Index greater or equal to 25 kg/m2 and a sedentary lifestyle. We will use linear regression to analyze the data following the intention to treat principle.Impact: Both trials will provide valuable real-life evidence on the pragmatic implementation of offering lifestyle interventions to reduce the cardiovascular risk in PLHIV. The results will have immediate impact on current care for PLHIV in Switzerland and internationally. To the best of our knowledge, the proposed “Trials within a Cohort” are the first to be established in a national cohort, which will help to pave the way for efficient evidence generation through cohort studies in the future.
Amount: CHF 193,000
Funding type: fellowship
Funder scheme: MD-PhD fellowships (funded by SNSF)
Start date: 2023-09-01
End date: 2026-08-31
Investigator: Schönenberger, Christof Manuel
Institution: University of Basel – BS
Subfield: Emergency Medicine
Field: Medicine
Domain: Health Sciences
Funded outputs count: 15
Funder award ID: 221860
OpenAlex ID: G51552024