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SUCCESSFUL RECRUITMENT OF A MULTI-SITE INTERNATIONAL RANDOMIZED PLACEBO-CONTROLLED TRIAL IN PEOPLE WITH HIV WITH ATTENTION TO DIVERSITY OF RACE AND ETHNICITY: CRITICAL ROLE OF CENTRAL COORDINATION
Fitch, Kathleen V. et al. | Date Issued: 2020
Author
Fitch, Kathleen V.
Kileel, Emma M.
Looby, Sara E.
Zanni, Markella V.
Sanchez, Laura R.
Fichtenbaum, Carl J.
Overton, Edgar T.
Malvestutto, Carlos
Aberg, Judith A.
Klingman, Karin L.
Alston-Smith, Beverly
Lavelle, Judith
Rancourt, Anne
Badal-Faesen, Sharlaa
Cardoso, Sandra Wagner
Avihingsanon, Anchalee
Patil, Sandesh
Sponseller, Craig A.
Melbourne, Kathleen
Ribaudo, Heather J.
Cooper-Arnold, Katharine
Desvigne-Nickens, Patrice
Hoffmann, Udo
Douglas, Pamela S.
Grinspoon, Steven K.
Affilliation
Massachusetts General Hospital and Harvard Medical School. Metabolism Unit. Boston, MA, USA.
Massachusetts General Hospital and Harvard Medical School. Metabolism Unit. Boston, MA, USA.
Massachusetts General Hospital and Harvard Medical School. Metabolism Unit. Boston, MA, USA / Massachusetts General Hospital. Yvonne L. Munn Center for Nursing Research. Boston, MA, USA.
Massachusetts General Hospital and Harvard Medical School. Metabolism Unit. Boston, MA, USA.
Ohio State University Wexner Medical Center. Division of Infectious Diseases. Columbus, OH, USA.
University of Cincinnati College of Medicine. Division of Infectious Diseases. Cincinnati, OH, USA.
University of Alabama at Birmingham School of Medicine. Division of Infectious Diseases. Birmingham, AL, USA.
Ohio State University Wexner Medical Center. Division of Infectious Diseases. Columbus, OH, USA.
Icahn School of Medicine at Mount Sinai. Department of Medicine. New York, NY, USA.
NIH. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
NIH. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
NIH. NIAID. Office of the Director. Bethesda, MD, USA.
NIH. NIAID. Office of the Director. Bethesda, MD, USA.
University of Witwatersrand. Faculty of Health Sciences. Department of Internal Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Thai Red Cross AIDS Research Centre. HIV-NAT. Bangkok, Thailand / Chulalongkorn University. Faculty of Medicine. Department of Medicine. Bangkok, Thailand.
Johns Hopkins University Clinical Research Site. Byramjee Jeejeebhoy Medical College. Pune, India.
Kowa Pharmaceuticals America. Montgomery, AL, USA.
Gilead Sciences. Foster City, CA, USA.
Harvard TH Chan School of Public Health. Department of Biostatistics. Center for Biostatistics in AIDS Research. Boston, MA, USA.
NIH. National Heart, Lung, and Blood Institute. Bethesda, MD, USA.
NIH. National Heart, Lung, and Blood Institute. Bethesda, MD, USA.
Massachusetts General Hospital. Cardiac MR PET CT Program and Department of Radiology. Boston, MA, USA.
Duke University School of Medicine. Duke Clinical Research Institute. Durham, NC, USA.
Massachusetts General Hospital and Harvard Medical School. Metabolism Unit. Boston, MA, 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.
Keywords
Clinical Coordinating Center
HIV
REPRIEVE
Recruitment
Clinical coordinating center
Cardiovascular disease
Primary prevention
 
Publisher
Taylor & Francis
Citation
FITCH, Kathleen V. et al. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination. HIV Research & Clinical Practice, v. 21, n. 1, p. 1-15, Feb. 2020.
DOI
10.1080/25787489.2020.1733794
ISSN
2578-7489
Notes
REPRIEVE Investigators.