CNICS Data Elements

• CNICS collects demographics data which are available in a table format upon request. Contact Mary Thielen to request the demographics table.  For full data requests, use the process outlined under Get Started in CNICS
• Risk factors for HIV acquisition are coded according to the 1993 Centers for Disease Control and Prevention classification system (1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults. MMWR Recomm Rep 1992;41(RR-17):1-19)

Age Distribution in the CNICS Cohort by Year (1995-2025)
55% are currently 50 years or older, 29% are 60 years or older

• CNICS captures diagnoses prospectively recorded in the Electronic Health Record by treating clinicians during routine care; historical diagnoses are captured at a patient’s initial visit to a CNICS site
• Diagnosis data are mapped to the CNICS standard diagnosis codes and harmonized across CNICS sites
• Diagnoses in CNICS fall into three categories: (1) Verified diagnoses, or diagnoses verified through protocol-driven medical record review/central adjudication by expert panels of physicians; (2) Confirmable diagnoses, or diagnoses confirmed via laboratory values and/or medications using CNICS Operational Definitions; and (3) Unconfirmed diagnoses.

See examples of CNICS stroke and MI data below

1. Adjudicated Strokes and Ischemic Stroke Subtypes in the CNICS Cohort

2. Adjudicated MIs in the CNICS Cohort by Type (52% Type 1 MI, 48% Type 2 MI)
(adapted from Thygesen K, et al. J Am Coll Cardiol. 2012)

3. Adjudicated VTEs in the CNICS Cohort

• Laboratory test results are uploaded directly from clinical laboratory medicine systems and harmonized across CNICS sites implementing standard units and clinical interpretations
• Vital signs captured in CNICS include blood pressure and height and weight measurements that are used to compute BMI (see example in figure below)
• Examples of CNICS laboratory data are shown in the table below and provided in detail here (click table to enlarge)

See examples of CNICS HIV viral suppression, CD4 count, and BMI data below

1. Trends in Viral Suppression and Mean CD4 Count, 1998 – 2024

2. Transitions Between BMI Categories Following Initiation of Dolutegravir-based ART Regimens

Sankey diagram of changes in BMI category between antiretroviral therapy (ART) initiation [baseline] and 2 years post ART initiation [follow-up] among previously ART-naïve people living with HIV (PLWH) initiating dolutegravir (DTG)-based integrase strand transfer inhibitor (INSTI) ART regimens. In the first 2 years of treatment, a greater proportion of PLWH shifted to a higher BMI category compared to those who shifted to a lower BMI category.

• Medications prescribed, including start/stop dates, are entered into the Electronic Health Record by treating clinicians and used to compute courses of therapy
• Medications including antiretroviral regimens and Direct Acting Antiviral (DAA) drugs are verified through medical record review (see examples of CNICS ART and DAA data in figures below)
• Medications are added as care advances for PWH in routine clinical care, such as GLP-1RA (e.g. Semaglutide) and GLP-1/GIP (e.g. Tirzepatide)

1. ART Regimens by Drug Class in CNICS Cohort (2024)
*ex. Dolutegravir / Darunavir

Trends in ART by Core Class, 2002-2024

2. DAA Treatment Response in CNICS Cohort
(adapted from Kim H, et al. OFID. 2019) 

3. Novel Antidiabetic Medications and Weight Change Among PWH in CNICS

• CNICS captures viral resistance data including full nucleotide genotype, phenotype, and tropism assays and has the capability for expansion to include new drug targets
• CNICS genotypic resistance data are processed using the Stanford HIV Drug Resistance Database
• Study demonstrating Substantial Decline in Heavily Treated Therapy Experienced Persons with HIV with Limited Antiretroviral Treatment Options (see abstract and figures below; PubMed link here)

Objective: Historically, a high burden of resistance to antiretroviral therapy (ART) in heavily treatment-experienced (HTE) persons with HIV (PWH) resulted in limited treatment options (LTOs). We evaluated the prevalence, risk factors, and virologic control of HTE PWH with LTO throughout the modern ART era.

Design: We examined all ART-experienced PWH in care between 2000 and 2017 in the Centers for AIDS Research Network of Integrated Clinical Systems cohort.

Methods: We computed the annual prevalence of HTE PWH with LTO defined as having two or less available classes with two or less active drugs per class based on genotypic data and cumulative antiretroviral resistance. We used multivariable Cox proportional hazards models to examine risk of LTO by 3-year study entry periods adjusting for demographic and clinical characteristics.

Results: Among 27 133 ART-experienced PWH, 916 were classified as having LTO. The prevalence ofPWH with LTO was 5.2–7.5% in 2000–2006, decreased to 1.8% in 2007, and remained less than 1% after 2012. Persons entering the study in 2009–2011 had an 80%lower risk of LTOcompared with those entering in2006–2008 (adjusted hazard ratio 0.20; 95%confidence interval: 0.09–0.42). We found a significant increase in undetectable HIV viral loads among PWH ever classified as having LTO from less than 30% in 2001 to more than 80% in 2011, comparable with persons who never had LTO.

Conclusion: Results of this large multicenter study show a dramatic decline in the prevalence of PWH with LTO to less than 1% with the availability of more potent drugs and a marked increase in virologic suppression in the current ART era.

1. Annual Prevalence of PWH with Limited Treatment Options (LTO) Among ART-experienced Persons in Care by Year (2000–2017)

2. Percentage of Undetectable HIV Viral Load Tests by Year Among Antiretroviral-experienced PWH by Limited Treatment Option (LTO) Status (2000-2017)

AIDS 2020, 34:2051–2059

•  PROs are collected at CNICS sites using validated survey instruments (see references here) administered at routine clinical care visits with results available for use by clinicians at the time of the encounter
• Patients complete PRO assessments every four to six months using touch-screen tablets connected to a wireless network with SSL/TLS encryption
• Over 150,000 PRO assessments have been completed by over 32,000 patients in CNICS
• Recent expansion of PRO domains include items on Doxy-PEP, chemsex, exchange sex, and fentanyl test strips access among PWH reporting non-prescribed opioid use. Current expansion is adding items related to reasons for stopping long-acting ART among PWH who received it and then stopped.
• PROs are available in English, Spanish, Amharic, Brazilian Portuguese, and Haitian Creole to ensure generalizability.

Citations

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4. Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). J Acquir Immune Defic Syndr. Aug 15 2006;42(5):562-71.
5. Justice AC, et al. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. Dec 2001;54 Suppl 1:S77-90.
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17. Fredericksen RJ, et al. Development and content validation of the Multifactoral assessment of perceived social support (MAPSS), a brief, patient-reported measure of social support for use in HIV care. AIDS Care. Jun 12 2019:1-9.
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24. Hahn AW, et al. Vaporized nicotine (E-cigarette) and tobacco smoking among people with HIV: use patterns and associations with depression and panic symptoms. J Acquir Immune Defic Syndr. Mar 1 2023;92(3):197-203.
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• CNICS captures health care utilization data from outpatient encounter/appointment systems and hospital systems as shown in the table below

To date, ~13,000 PWH in CNICS have undergone genotyping with the Illumina Infinium MEG series and GDA with pharmacogenetic booster arrays that measure ~6 million common and rare genetic variants.

– Genetic data were used to develop the Heat Map of Polygenic Risk Scores in the CNICS Cohort (European American and African American Sub-cohorts Combined) shown in the figure below.

Reference: Genetic architecture of cardiometabolic risks in people living with HIV H. Chang, A. Sewda, C. Marquez-Luna, S. R. White, B. M. Whitney, J. Williams-Nguyen, et al. BMC Med 2020 Vol. 18 Issue 1 Pages 288.  Accession Number: 33109212 PMCID: PMC7592520 DOI: 10.1186/s12916-020-01762-z

– Polygenic Risk Scores Associated with Development of Type 1 vs. Type 2 Myocardial Infarctions in PWH are shown in the figure below.

Reference: Polygenic risk scores point toward potential genetic mechanisms of type 2 myocardial infarction in people with HIV W. J. Lee, H. Cheng, B. M. Whitney, R. M. Nance, S. R. Britton, K. Jordahl, et al. Int J Cardiol 2023 Vol. 383 Pages 15-23. Accession Number: 37149004 PMCID: PMC10247524 DOI: 10.1016/j.ijcard.2023.04.058

• CNICS sites maintain local death registries and collect death data from State Death Certificates and National Death Indexes to ensure complete ascertainment of death dates
• Data regarding causes of death are obtained from the National Death Index (NDI)+, State Death Certificates, and medical record review (causes of death are unknown for approximately 35% of the CNICS cohort overall)

• CNICS sites submit geographic information on participants’ place of residence in compliance with HIPAA requirements including aggregate geographic levels such as city, state, and 5-digit ZIP code
• CNICS is expanding geocoded residential address data for linkage with national longitudinal data sources to facilitate research on built and social neighborhood environment data based on census tracts.
• To date, >240,000 historical address records for >28,000 PWH have been successfully geocoded.

Example: Viral Load and Social Vulnerability by Census Track in Seattle, WA

• The CNICS Specimen Core provides access to biologic specimens linked to patients’ comprehensive clinical data in the CNICS Research Platform. Information about specimens available in the CNICS Specimen Repository is provided here.
• Currently there are 278,001 biological specimens stored in 818,345 aliquots in site repositories representing 172,830 time points linked to 22,069 unique PWH collected between 1987 and 2024.