Sentinel Research Network (SRN) of IeDEA: Study Protocol
Authors: Jaquet Antoine , Anastos Kathy , Chihota Belinda , Dabis François , Davies Mary-Ann , Duda Stephanie N , Egger Matthias , Ekouevi Didier , Gupta Samir Kumar , Lancaster Kathryn E , Law Matthew , McGowan Catherine , Musick Beverly , Nash Denis , Parcesepe Angela , Perazzo Hugo , Ross Jeremy , Semeere Aggrey , Sohn Annette , von Groote Per , Wandeler Gilles , Wools-Kaloustian Kara , Yiannoutsos Constantin , Yotebieng Marcel 
Published: August 2020

BACKGROUND The global scale up of antiretroviral therapy (ART) has significantly improved the immune recovery and life expectancy of people living with HIV (PLHIV). However, PLHIV on long-term ART now face health challenges related to non-communicable diseases (NCDs). We know that exposures such as tobacco, alcohol, diet and exercise are associated with the risk of NCDs. In addition, alcohol is one of the most commonly used substances globally and unhealthy drinking commonly co-occurs with mental health disorders. However, limited data are available in low- and middle-income country (LMIC) settings on the intersection between HIV, NCDs, mental health, and use of alcohol and other substances. As the population of PLHIV increases and ages, it is imperative that we understand the burden of NCDs and risk factors for NCD development as well as their impact on long-term health outcomes.AIMS To establish a network of research sites, the Sentinel Research Network (SRN), and to capture and analyze standardized data among PLHIV in LMICs. Through this network, we further seek to implement studies on cardiovascular risk factors, mental health, alcohol and other substance use disorders, as well as liver disease prevalence/incidence and associated factors among PLHIV accessing care in LMICs.METHODS Create a “sentinel” cohort nested in the pre-existing regional networks of the International epidemiologic Databases to Evaluate AIDS (IeDEA) cohorts based in LMICs. A total of 2, 925 people living with HIV (PLHIV) ≥40 years old and on ART ≥6 months are expected to be recruited at 12 HIV clinics participating in the IeDEA SRN project from the four African regions (East, Central, Southern and Western Africa), Asia-Pacific and Southern America. These participants will be assessed at baseline for various chronic conditions and their risk factors, including diabetes, dyslipidemia, hypertension, drug and alcohol abuse, as well as chronic liver diseases, through standardized questionnaires and non-to-minimally invasive “bedside” screening tests. Follow-up visits are planned at month six, month twelve, month twenty-four and month thirty-six for reassessment of these chronic conditions and also document incident cardiovascular outcomes. Data prospectively collected through the SRN will be merged with pre-existing HIV-related data routinely collected through IeDEA cohorts.EXPECTED RESULTS To date, the IeDEA consortium houses data on nearly 1.5 million adults and 150,000 children and adolescents living with HIV and has been studying treatment and other HIV-related outcomes since 2006. The establishment of the SRN will allow IeDEA investigators to better evaluate additional risk factors and co-morbidities associated with aging and HIV in standardized ways. Through the SRN, IeDEA will also develop the research infrastructure needed to enhance the design and validation of data collection tools related to these co-morbidities.