REPRIEVE and the ACTG Network are issuing a collaborative Request for Proposals (RFP). The RFP will be open to investigators at REPRIEVE sites (both ACTG and REPRIEVE protocol-specific sites). Currently, this request is limited to data, including clinical data and currently available lab and biomarker data. Requests for samples may be considered in a future RFP.
Please review this page in detail for instructions and resources related to this RFP. Available resources include the REPRIEVE protocol (which contains a schedule of evaluations), the REPRIEVE Manual of Procedures (MOPS), the REPRIEVE Publications Standard Operating Procedures (SOP), available labs and biomarkers, baseline characteristics of REPRIEVE participants and available clinical outcomes, and dataset availability.
This RFP will take place in two stages. First, investigators will submit a Letter of Intent (LOI) via the ACTG website by 11:59 PM EST on December 10, 2024. If there are overlapping LOIs submitted, investigators with such LOIs will be contacted by the ACTG to facilitate possible collaboration. Meritorious projects identified in the initial LOI review phase will be selected for the second phase of the review process, which will include a full proposal application process. Investigators with such LOIs will receive further instructions to submit a full proposal.
Second, investigators will submit a proposal via the ACTG website by April 1st, 2025 (provisional timeline). Up to approximately 7-10 meritorious proposals will be selected, based on scientific importance, availability of data, nonoverlap with any past, current or planned proposals, feasibility, and robustness of the statistical plan.
Decisions will be announced in May 2025. Depending on data availability and resources, subsequent RFP’s may be issued for REPRIEVE data. Highly ranked projects not accepted in the first RFP may be resubmitted in a subsequent RFP for REPRIEVE data sharing. The REPRIEVE Publications SOP outlines requirements and next steps for subsequent manuscript development.
Please review the list of current projects approved and under development by the REPRIEVE team, the REPRIEVE Ancillary Studies, and past REPRIEVE manuscripts before beginning a submission for this RFP and to ensure that there is not overlap with a past or ongoing REPRIEVE project. The current projects below largely represent prespecified Aims of the original REPRIEVE grant, supplementally funded Aims, and/or planned investigations of relevant areas of interest. Proposals submitted through this RFP for projects that were completed or are already underway cannot be approved. However, REPRIEVE will continue to solicit interest and create opportunities for site investigators to join the authorship teams of existing projects. To express interest in joining an existing project or if you have questions regarding overlap with a current REPRIEVE project, please contact the REPRIEVE Team (mghreprievetrial@mgb.org).
Authorship: The lead author will submit a list of potential co-authors based on contribution and/or planned contribution with the initial proposal to the ACTG. For accepted proposals, at least one REPRIEVE Chair and Vice Chair and additional co-authors (based on contribution to the main trial, expertise, and equitable sharing of opportunities) will be assigned to each proposal and subsequent manuscripts. The final list of authors and author order will be approved by the REPRIEVE Publications and Executive Committees. All authors must meet ICMJE authorship requirements. Further details about authorship can be found in the REPRIEVE Publications SOP.
Statistical Analysis and Support: Proposals should outline the plan for statistical analysis and the sources of support for this plan. For example, does the proposal envision analysis of the data by a statistician outside of REPRIEVE, and if so, what is the level of experience of the statistical team and funding source for this analysis. Alternatively, does the proposal envision the analysis to be coordinated through the REPRIEVE Data Coordinating Center (DCC) / Center for Biostatistics in AIDS Research (CBAR), and if so, what will the funding source be, e.g. application for an external grant, ACTG SDAC application, or another source. In all cases, the proposed effort and methodologies to be used for the statistical analysis must be outlined. If a full proposal is under consideration for approval, proposers will be given an opportunity to estimate statistical effort with the REPRIEVE statistical core. If a statistical analysis is to occur at an outside institution, the analysis and proposed statistical team must be approved by the REPRIEVE statistical core, with sources of support outlined.
Institutional Review Board (IRB) and Data Use Agreement (DUA) Requirements: The proposals accepted from this RFP will be subject to the approval of relevant regulatory and contractual requirements. Investigators who propose to receive data to conduct secondary analyses will need to contact their institution’s IRB about the need for IRB submission. Data Use Agreements (DUA) must be executed in compliance with the NIH Data Management and Sharing Policy, the Federal Awarding Agency’s data sharing and access requirements, and MGB policies.
DUAs will be executed between Mass General Brigham (MGB) and the investigator's institution to govern the sharing and use of data. There are two categories of DUAs: low-risk and high-risk.
- Low-Risk DUA: This agreement applies to non-profit United States entities and involves data exchanges that meet specific criteria to ensure minimal risk to privacy and confidentiality. The following conditions apply:
- Recipient Type: Non-profit U.S. entity.
- Institutional Review Board (IRB) or Human Research Committee Approval: The institution’s IRB or Human Research Committee must have reviewed and approved the data exchange or issued an exemption determination.
- Data Type: The data shared must be classified as either a Limited Data Set or De-identified Data. (Click here to view a chart that defines De-identified and Limited Data).
- Details of Exchange: The exchange of data must meet specific conditions, including not being used for machine learning or artificial intelligence purposes, or for the development or improvement of tangible intellectual property such as patentable inventions, medical devices, or software. A detailed list of requirements for the data exchange will be provided during the agreement discussions.
- High-Risk DUA: This agreement applies to data exchanges that do not meet all the criteria for low-risk DUAs; including those involving international entities or organizations outside the United States.
Inquiries: Please send all inquiries to ACTGProposals@dlhcorp.com. For investigators with inquiries regarding the REPRIEVE Trial or proposal development, please email mghreprievetrial@mgb.org.
Click here for the REPRIEVE protocol
Click here for the REPRIEVE Manual of Procedures (MOPs)
Click here for the REPRIEVE Publications Standard Operating Procedures (SOP)
Click here for a Testing Completeness Report which includes available labs and biomarkers*
Click here for a list of baseline characteristics of REPRIEVE participants and available clinical outcomes
Click here for a list of the REPRIEVE analysis datasets
*The flow cytometry data is currently being analyzed, and as such, the data is not available at this time.
Current Projects Approved and Under Development by the REPRIEVE Team*
*Additional projects may be in the planning stage by the REPRIEVE Team.
Click here to learn about the REPRIEVE Ancillary Studies
Click here to review past REPRIEVE publications
REPRIEVE Main Study (A5332)
- Performance of the ACC/AHA Pooled Cohort Equations, PREVENT, and SCORE 2 in REPRIEVE and Recalibration
Lead Author(s): Steve Grinspoon, Markella Zanni, Pamela Douglas - Prognostic Factors of Major Adverse Cardiovascular Events
Lead Author(s): Markella Zanni, Steve Grinspoon - Statin Effects on Non-CVD Endpoints/Non-Adjudicated Events (START Endpoint)
Lead Author(s): Marissa Diggs, Triin Umbleja - Effects of Antiretroviral Therapy Exposure (Never/Former/Current) on Major Adverse Cardiovascular Events
Lead Author(s): Carl Fichtenbaum, Carlos Malvestutto - Effects of NRTI (Abacavir, TDF, TAF) on Major Adverse Cardiovascular Events
Lead Author(s): Emma Davies Smith, Carlos Malvestutto, Carl Fichtenbaum - Statin Effects on Cognitive Function in REPRIEVE and HAILO
Lead Author(s): Kristine Erlandson - Effects of INSTIs on Blood Pressure and the Mediating Effects of Kidney Function and BMI
Lead Author(s): Alana Brennan, Emma Kileel, Jen Manne-Goehler - Cost and Cost-Effectiveness of Pitavastatin to Prevent Cardiovascular Disease in People with HIV
Lead Author(s): Thomas Mayrhofer, Michael Lu - Analysis of a Frailty Index in REPRIEVE
Lead Author(s): Ariela Orkaby, Kristine Erlandson, Alan Landay, George Kuchel - Global Burden of Disease Effects on Major Adverse Cardiovascular Events
Lead Author(s): Gerald Bloomfield, Pamela Douglas - Heart Failure and Heart Failure Risk Factors in REPRIEVE
Lead Author(s): Gerald Bloomfield, Pamela Douglas - Mechanisms of Pitavastatin Effects: LDL vs. inflammation
Lead Author(s): Steve Grinspoon, Pamela Douglas - Statin Effects and Role of Other Lipids in Cardiovascular Disease: TGL, HDL, lp(a)
Lead Author(s): Steve Grinspoon, Pradeep Natarajan - Predictors of Weight Change and INSTI Effects
Lead Author(s): Emma Kileel, Heather Ribaudo, Steve Grinspoon - Life's Essential 8 and Major Adverse Cardiovascular Events
Lead Author(s): Pamela Douglas, Steve Grinspoon - Predictors of Myalgia in REPRIEVE
Lead Author(s): Kristine Erlandson - Statin Effects on Cancer
Lead Author(s): Steve Grinspoon - Sex and Reproductive Aging Effects on Major Adverse Cardiovascular Events
Lead Author(s): Markella Zanni - Personalized Prediction Effects of Statins
Lead Author(s): Evelyne Zhang - EKG Predictors of Major Adverse Cardiovascular Events
Lead Author(s): Aya Awwad, Gerald Bloomfield, Chris deFilippi - ECG Features and Risk of Sudden Cardiac Death in REPRIEVE
Lead Author(s): Christopher deFilippi, Aya Awwad, Stephen Wiviott, Pamela Douglas, Steve Grinspoon - Hypertension and MACE in REPRIEVE
Lead Author(s): Steve Grinspoon - Win Ratios in REPRIEVE
Lead Author(s): Emma Davies Smith, Heather Ribaudo - Viral Load Effects on MACE
Lead Author(s): Steve Grinspoon - Analysis of Body Roundness Index in REPRIEVE
Lead Author(s): Aya Awwad, Steve Grinspoon - Factors Associated with Type 1 vs. Type 2 Myocardial Infarction and Statin Effects
Lead Author(s): Markella Zanni, Steve Grinspoon
REPRIEVE Mechanistic Substudy (A5333s)
- Statin Effects on Transcriptomics and Related Outcomes (Plaque, Diabetes, Liver, and Others)
Lead Author(s): Steve Grinspoon - Statin Effects on Pericoronary Fat Attenuation (PCAT) and Epicardial Fat
Lead Author(s): Borek Foldyna - HIV, Cardiovascular Disease Risk and Coronary Atherosclerosis: A cross-country comparison between the United States and Uganda
Lead Author(s): Mark Siedner, Brian Ghoshhajra - Epigenetic Aging in REPRIEVE
Lead Author(s): Michael Corley, Alan Landay, Kristine Erlandson, Steve Grinspoon - REPRIEVE Mechanistic Substudy Biomarkers Analysis
Lead Author(s): Michael Lu, Steve Grinspoon - Association Between Risk Factors, Inflammatory Markers and Coronary Atherosclerotic Radiomic Phenotypes in People with HIV
Lead Author(s): Marton Kolossvary, Michael Lu - Proteomics Analysis of INSTI Use in REPRIEVE
Lead Author(s): Marton Kolossvary, Emma Kileel - Health-Related Quality of Life and Atherosclerotic Cardiovascular Disease
Lead Author(s): Kathleen Fitch, Marissa Diggs - Plaque Presence, Progression, and MACE in the REPRIEVE Mechanistic Substudy
Lead Author(s): Michael Lu, Steve Grinspoon - Individual Plaque Analyses in the REPRIEVE Mechanistic Substudy
Lead Author(s): Michael Lu, Borek Foldyna, Thomas Mayrhofer, Heather Ribaudo - Statin Effects on Coronary Plaque Composition and Calcification
Lead Author(s): Michael Lu, Borek Foldyna - Machine Learning Prediction of Coronary Plaque, Plaque Progression, and Major Adverse Cardiovascular Events
Lead Author(s): Michael Lu - Computational Fluid Dynamics to Predict Coronary Plaque and Plaque Progression
Lead Author(s): Michael Lu - Prognostic Factors of Plaque Progression
Lead Author(s): Michael Lu - Aortic Plaque and Inflammation
Lead Author(s): Michael Lu, TBD - Cardiac Morphology and Changes with Statins
Lead Author(s): Michael Lu, Borek Foldyna - Lung Health and Inflammation with Statin Therapy
Lead Author(s): Michael Lu, TBD - Incidental Findings on Cardiac CT in HIV
Lead Author(s): Nina Meyersohn, Sandeep Hedgire, Michael Lu - Antiretroviral Therapy and Coronary Artery Plaque
Lead Author(s): REPRIEVE Substudy Team - Longitudinal Analysis of Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead Author(s): REPRIEVE Substudy Team - Effects of Sex Hormones on Coronary Artery Plaque
Lead Author(s): Markella Zanni, Sara Looby
REPRIEVE Ancillary Studies
- Statin Effects on Muscle Function and Frailty in PREPARE
Lead Author(s): Kristine Erlandson - Statin Effects on Cardiac Structure and Function
Lead Author(s): Tom Neilan, Markella Zanni - Longitudinal Analysis of Kidney Function in REPRIEVE
Lead Author(s): E Turner Overton - Clonal Hematopoiesis of Indeterminate Potential and Major Adverse Cardiovascular Events
Lead Author(s): Romit Bhattacharya, Aniruddh Patel, Pradeep Natarajan - Polygenic Risk Scores and Major Adverse Cardiovascular Events
Lead Author(s): Aniruddh Patel, Roger Zou, Romit Bhattacharya, Pradeep Natarajan - Sex Differences in Statin-Induced Immunomodulation
Lead Author(s): Markella Zanni, Sara Looby - Effects of Reproductive Aging vs. Chronologic Aging on ASCVD Events in Women
Lead Author(s): Sara Looby, Markella Zanni - Genetics of Diabetes in REPRIEVE
Lead Author(s): Luke Wander, Josep Mercader