Kathleen V Fitch1, Emma M Kileel1, Sara E Looby1,2, Markella V Zanni1, Laura R Sanchez3, Carl J Fichtenbaum4, Edgar T Overton5, Carlos Malvestutto3, Judith A Aberg6, Karin L Klingman7, Beverly Alston-Smith7, Judith Lavelle8, Anne Rancourt8, Sharlaa Badal-Faesen9, Sandra Wagner Cardoso10, Anchalee Avihingsanon11, Sandesh Patil12, Craig A Sponseller13, Kathleen Melbourne14, Heather J Ribaudo15, Katharine Cooper-Arnold16, Patrice Desvigne-Nickens16, Udo Hoffmann17, Pamela S Douglas18, Steven K Grinspoon1. 1. Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. 2. Yvonne L. Munn Center for Nursing Research, Massachusetts General Hospital, Boston, MA, USA. 3. Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH, USA. 4. Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA. 5. Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA. 6. Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 7. National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA. 8. Office of the Director, NIAID, NIH, Bethesda, MD, USA. 9. Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. 10. Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil. 11. HIV-NAT, Thai Red Cross AIDS Research Centre; and Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. 12. Byramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India. 13. Kowa Pharmaceuticals America, Inc, Montgomery, AL, USA. 14. Gilead Sciences, Inc, Foster City, CA, USA. 15. Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA. 16. National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA. 17. Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA, USA. 18. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Abstract
Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities.Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino.Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.
RCT Entities:
Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities.Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino.Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.
Authors: Thomas M Ramsey; Joni K Snyder; Laura C Lovato; Christianne L Roumie; Steven P Glasser; Nora M Cosgrove; Christine M Olney; Rocky H Tang; Karen C Johnson; Carolyn H Still; Lisa H Gren; Jeffery C Childs; Osa L Crago; John H Summerson; Sandy M Walsh; Letitia H Perdue; Denise M Bankowski; David C Goff Journal: Clin Trials Date: 2016-02-24 Impact factor: 2.486
Authors: Steven K Grinspoon; Kathleen V Fitch; Edgar Turner Overton; Carl J Fichtenbaum; Markella V Zanni; Judith A Aberg; Carlos Malvestutto; Michael T Lu; Judith S Currier; Craig A Sponseller; Myron Waclawiw; Beverly Alston-Smith; Katharine Cooper-Arnold; Karin L Klingman; Patrice Desvigne-Nickens; Udo Hoffmann; Heather J Ribaudo; Pamela S Douglas Journal: Am Heart J Date: 2019-03-04 Impact factor: 4.749
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Authors: Anoop S V Shah; Dominik Stelzle; Kuan Ken Lee; Eduard J Beck; Shirjel Alam; Sarah Clifford; Chris T Longenecker; Fiona Strachan; Shashwatee Bagchi; William Whiteley; Sanjay Rajagopalan; Shyamasundaran Kottilil; Harish Nair; David E Newby; David A McAllister; Nicholas L Mills Journal: Circulation Date: 2018-09-11 Impact factor: 29.690
Authors: Kristine M Erlandson; Kathleen V Fitch; Sara A McCallum; Heather J Ribaudo; Edgar T Overton; Markella V Zanni; Gerald S Bloomfield; Todd T Brown; Carl J Fichtenbaum; Sara Bares; Judith A Aberg; Pamela S Douglas; Evelynne S Fulda; Jorge L Santana-Bagur; Jose G Castro; Laura E Moran; Vidya Mave; Khuanchai Supparatpinyo; Ponego L Ponatshego; Mauro Schechter; Steven K Grinspoon Journal: Clin Infect Dis Date: 2022-09-30 Impact factor: 20.999