Aima A Ahonkhai1,2, Usman J Wudil3, Faisal S Dankishiya4, Donna J Ingles3, Baba M Musa4,5, Hamza Muhammad4, Mahmoud U Sani4, Aisha M Nalado4, Aliyu Abdu4, Kabiru Abdussalam6, Leslie Pierce3, C William Wester3,7, Muktar H Aliyu3,8. 1. Vanderbilt Institute for Global Health (VIGH), Vanderbilt University Medical Center (VUMC), 2525 West End Ave, Suite, Nashville, TN, 750, USA. aimalohi.a.aahonkhai@vumc.org. 2. Department of Medicine, Division of Infectious Diseases, Vanderbilt University Medical Center (VUMC), Nashville, TN, USA. aimalohi.a.aahonkhai@vumc.org. 3. Vanderbilt Institute for Global Health (VIGH), Vanderbilt University Medical Center (VUMC), 2525 West End Ave, Suite, Nashville, TN, 750, USA. 4. Department of Medicine, Bayero University Kano (BUK) and Aminu Kano Teaching Hospital (AKTH), Kano, Nigeria. 5. African Center of Excellence in Population Health and Policy (ACEPHAP), Bayero University Kano (BUK), Kano, Nigeria. 6. Department of Chemical Pathology, Aminu Kano Teaching Hospital (AKTH), Kano, Nigeria. 7. Department of Medicine, Division of Infectious Diseases, Vanderbilt University Medical Center (VUMC), Nashville, TN, USA. 8. Department of Health Policy, Vanderbilt University Medical Center (VUMC), Nashville, TN, USA.
Abstract
PURPOSE OF REVIEW: Clinical trials represent a bedrock for measuring efficacy of interventions in biomedical research, but recruitment into clinical trials remains a challenge. Few data have focused on recruitment strategies from the perspective of clinical trial teams, especially in low- and middle-income countries (LMIC), where HIV is most prevalent. RECENT FINDINGS: We summarized data from the literature and our experience with recruitment for the Renal Risk Reduction trial, aimed at reducing risk of kidney complications among people living with HIV in Nigeria. Using an implementation science framework, we identified strategies that contributed to successful clinical trial recruitment. For strategies that could not be categorized by this framework, we summarized key features according to selected action, actor, target, context, and time. We identified how these identified strategies could map to subsequent implementation outcomes at the patient and provider/health system level, as well as capacity-building efforts to meet needs identified by LMIC partners, which is a priority for success. Our experience highlights the importance of considering implementation outcomes, and the strategies necessary to achieve those outcomes early, in the planning and execution of clinical trials. Clinical trial recruitment can be optimized via methodologies grounded in implementation science.
PURPOSE OF REVIEW: Clinical trials represent a bedrock for measuring efficacy of interventions in biomedical research, but recruitment into clinical trials remains a challenge. Few data have focused on recruitment strategies from the perspective of clinical trial teams, especially in low- and middle-income countries (LMIC), where HIV is most prevalent. RECENT FINDINGS: We summarized data from the literature and our experience with recruitment for the Renal Risk Reduction trial, aimed at reducing risk of kidney complications among people living with HIV in Nigeria. Using an implementation science framework, we identified strategies that contributed to successful clinical trial recruitment. For strategies that could not be categorized by this framework, we summarized key features according to selected action, actor, target, context, and time. We identified how these identified strategies could map to subsequent implementation outcomes at the patient and provider/health system level, as well as capacity-building efforts to meet needs identified by LMIC partners, which is a priority for success. Our experience highlights the importance of considering implementation outcomes, and the strategies necessary to achieve those outcomes early, in the planning and execution of clinical trials. Clinical trial recruitment can be optimized via methodologies grounded in implementation science.
Authors: Christine Heumann; Susan E Cohn; Supriya Krishnan; Jose R Castillo-Mancilla; Michelle Cespedes; Michelle Floris-Moore; Kimberly Y Smith Journal: South Med J Date: 2015-02 Impact factor: 0.954