Methodological Challenges in Biomedical HIV Prevention Trials (2008) / Chapter Skim
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6 Design Considerations: Recruitment and Retention
6 Design Considerations: Recruitment and Retention
Pages 148-159
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From page 148... ...
A slow accrual rate or poor retention of trial participants may result in underpowered or biased results. To ensure confidence in trial outcomes, it is essential for investigators to meet the study's accrual goals and maximize participant retention.
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The committee identified two systematic reviews of recruitment strategies (Lovato et al., 1997; Mapstone et al., 2007)
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These are briefly reviewed below. • Establishing an Overall Recruitment Plan: Studies with successful recruitment strategies have sufficient time to plan, establish community awareness and education, and make personal contacts (Lovato et al., 1997)
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Regions with high rates of HIV incidence often have high rates of HIV prevalence, so study staff may need to screen many individuals to identify enough eligible uninfected participants, thus increasing the cost of the trial. • Monitoring Accrual: Continuous monitoring of recruitment strategies and enrollment targets is important for identifying areas for improvement and modifying recruitment strategies when needed.
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From page 152... ...
of participants become HIV infected during the trial, striving to keep the cumulative number of LFUs that could be informative below this number is prudent, especially if the LFU rates between the intervention arms might differ. Examples of factors that might affect retention include loss of interest in the study, conflicts in scheduling visits, transportation issues, site location, poor health, familial obligations, financial difficulties, conflicts with jobs, requirements to forego pregnancy throughout the trial, stringent instructions to adhere to study products, mistrust of trial staff or fear a breach of confidentiality, or stigma associated with an HIV-related study (Coday et al., 2005; Mills et al., 2006; Tolley and Severy, 2006)
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. They found that successful retention requires motivational systems designed to engage and reward individuals at all levels of the trial including project managers and field staff, participants, and community organizations (Leonard et al., 2003)
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reviewed strategies for retaining study participants in behavioral intervention trials and identified 61 strategies grouped into eight themes: • Emphasizing the benefits of participation • Minimizing respondent burden and giving control to participants • Providing incentives and tokens of appreciation • Giving tangible support (e.g., transportation expenses) • Being patient and persistent • Being flexible • Enlisting the support of others and providing social support • Maintaining a good tracking system Among these, provision of incentives was highly rated as an effective retention strategy.
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examined review articles and longitudinal studies that focused on practical and clinically relevant attrition lowering strategies. They identified eight narrative reviews that suggested three categories of promising retention strategies.
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Encourage study personnel to show empathy toward subject's personal situation in scheduling appointments/cancellations. Study description Explain study Inform subjects that they requirements and details, will be followed over time including potential and specify the timetable benefits and risks, to and the methods that will participants.
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M Needham, Systematic review identifies number of strategies important for retaining study participants, 757-765, Copyright Elsevier (2007)
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2005. Strategies for retaining study participants in behavioral interven tion trials: Retention experiences of the NIH Behavior Change Consortium.
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2007. Systematic review identifies number of strategies important for retaining study participants.
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