Tripartite and MVP

The scope of activities for each MVP-related study is defined by its funding award, corresponding regulatory approvals, and any agreed upon terms with MVP leadership— including the study’s Executive Committee—for use of its resources. Related issues (not described in this document) include access to genomic and phenomic data, as well as requests for MVP biospecimens or for re-contact of MVP participants. MVP’s long-term goals include making results of scientific activities available to VA, the broader scientific community, and the public in accordance with VA policy. Publications and dissemination of results are seen as part of a larger set of contributions MVP will make towards its goal of advancing precision medicine. Policy Statement: MVP’s publication policy aims to protect the integrity of MVP studies and the welfare of MVP participants, while encouraging dissemination of results as well as considering prerequisite activities for investigator-authors. The MVP EC oversees all aspects of this policy and reports to the VA Office of Research and Development (ORD). Overview of Procedures: To help ensure overall MVP study integrity, support the conduct of ethical and high-quality research, and avoid duplicative publications, proposals for scientific products (herein referred to as abstracts and manuscripts) should be submitted—in advance of their preparation—to the MVP Publication Committee, as constituted by the MVP EC. All abstract and manuscript proposals and subsequent submissions must be available for Publication Committee review, whether they involve a single study, a subset of a study, or a series of studies. If the Publication Committee believes that a product should more appropriately involve a wider or a narrower scope of data, then this recommendation will be made to the applicants. The MVP Publication Committee will catalog and track each submission; it will also maintain a library of published products as they become available. The Publication Committee administrator will be responsible for logging each application, assigning an abstract or manuscript proposal number, following progress, and informing the applicant of the Publication Committee’s decisions. 10 May 2017 2 Of note, abstract or manuscript proposals may be included in the original request for MVP data access or other procedures when participating in MVP; details will be provided in corresponding instructions.

Our long term goal is to inform intervention design and implementation. Together we will study biomedical consequences of alcohol and associated substance use in HIV extending the scope and generalizability of VACS from a single national healthcare system to 12 systems across 10 North American and European countries, doubling the HIV+ sample and substantially increasing the diversity of subjects. Importantly, COMpAAAS Tripartite also extends the pool of uninfected comparators (more women, young patients, and HCV+) available for analyses, a critical step if we are to understand how alcohol differentially affects individual biomedical outcomes by HIV status by gender, age, and HCV status. Using propensity and related methods and variables tailored to each aim and hypothesis, we will closely match HIV+ subjects with uninfected comparators drawing from 3.7 million KP members (1.9 million women) and 5 million veterans born in 1945-1965 (Birth Cohort, includes 450,000 HCV+). ART-CC, KP, and VA will also participate in an HIV+ substudy (n=2250), The Medications, Alcohol, Substance use in HIV Study (MASH), involving new, prospective data on potentially inappropriate medications (PIMS) and direct biomarker measurements for alcohol and associated substances (tobacco, marijuana, opioids, cocaine, and methamphetamine). All three teams contribute and share data for all aims and have identical aims and protocols. VA will coordinate sharing limited data sets based on the HIV Cohorts Data Exchange Protocol (HICDEP) a standardized format for data sharing. Standardized methods for data cleaning, imputation, and analyses will be employed. Each collaborator will lead analysis for one aim based self-report alcohol and substance use data in year 1, updated in year 3, and measurement corrected data from MASH in year 4.