Methodological Challenges in Biomedical HIV Prevention Trials (2008) / Chapter Skim
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7 Site Preparedness
7 Site Preparedness
Pages 160-174
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This work includes developing the needed human capacity, physical infrastructure, and regulatory processes, and performing pretrial research -- sometimes simultaneously. The costs and resources needed to complete these steps can be substantial.
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Although this report does not address these complicated and sensitive issues, additional work is needed to reach consensus on how to address them when planning a latestage HIV prevention trial. DEVELOPING CAPACITY AND INFRASTRUCTURE The HIV prevention research agenda requires access to large study populations in settings with the capacity to conduct a wide range of clinical trials.
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• Participants' reasons for joining trials include reimbursement, access to bet ter medical care, access to microbicide gel as lubrication and thus better sex, and Human Capacity To be successful, late-stage HIV prevention trials require a well-trained and coordinated study team that includes laboratory managers and technicians, pharmacists, data and information technology staff, regulatory personnel, research nurses, HIV counselors, home visitors, social scientists, physicians, and others. The lack of personnel in developing countries who are trained or experienced in conducting clinical trials is repeatedly cited as a major limitation (Initiative on Public-Private Partnerships for Health, 2002; Vardas et al., 2005; Excler, 2006)
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Some po tential participants lack enough information to distinguish different HIV prevention trials. Media play an important role in disseminating both correct and incorrect information.
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The National Institute of Child Health and Development's International Extramural Associates Program provides training and support in some of these areas. A comprehensive approach to training is required to build the longterm, sustainable, and independent research capacity to rapidly mount large-scale HIV prevention trials in developing countries.
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Physical Infrastructure Physical infrastructure includes adequate facilities for recruiting, screening, and following study participants; providing pharmacy services for the trial interventions and concomitant care; ensuring reliable laboratory services; and managing data. New research sites usually require significant up-front investment in all of these areas.
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. Modern information technology and data management capabilities, including computer resources and Internet links, are also essential for latestage HIV prevention trials, to ensure effective communication and the ability to rapidly and accurately enter, analyze, and transmit data and report adverse events (Nchinda, 2002; Lehner et al., 2005; Van den Broeck et al., 2007)
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This often presents a challenge and can cause significant delays for multicenter trials with multiple layers of review in each participating country (NIMH Collaborative HIV/STD Prevention Trial Group, 2007a)
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As the 2007 UNAIDS and AVAC report Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials notes, "Best practices build in mechanisms for input from both local investigators and communities prior to trial protocol finalization and for participation of local investigators and community representatives on the protocol team" (UNAIDS and AVAC, 2007, p.
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The trial should itself promote equal partnerships between outside and local investigators. PRETRIAL RESEARCH Qualitative pretrial research is critical in developing culturally relevant adaptations of interventions, informed consent, and study procedures; facilitating site selection; and in working closely with a community (Corneli et al., 2007; NIMH Collaborative HIV/STD Prevention Trial Group, 2007b; Vallely et al., 2007)
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Recommendation 7-4: Donors should fund and investigators should undertake extensive pre-trial research to develop accurate estimates of HIV incidence, participant accrual, retention, and pregnancy rates, and to develop and evaluate logistical and regulatory processes to be used during the trial. ENSURING SUSTAINABILITY In light of the extensive efforts required to prepare a site for an HIV prevention trial, and the need for further HIV prevention trials in any given study area, funders and investigators need to consider sustaining site capacity beyond the needs of a given prevention trial.
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If investigators or donors do not expect the human capacity and site infrastructure to continue beyond the planned trial, the committee questions the value to the community of the investment in preparing a new site. Sponsors have established many HIV-related research networks and local cohorts of potential trial participants over the last decade, with the goal of expanding the capacity to conduct HIV prevention and treatment trials in both the developed and developing world (Brown and Nitayaphan, 2004)
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November 2002. Workshop on clinical trials capacity in low-and middle-income countries: Experiences, lessons learned and priorities for strengthening, Arusha, Tanzania.
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2007a. The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: Experience from the HPTN 055 study.
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Clinical Trials 4(5)
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