Novel strategies implemented to ensure high participant retention rates in a community based HIV prevention effectiveness trial in South Africa and Zimbabwe
Novel strategies implemented to ensure high participant retention rates in a community based HIV prevention effectiveness trial in South Africa and Zimbabwe
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DOI：
10.1016/j.cct.2009.05.002
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发表时间：
2009-09-01
影响因子：
2.2
通讯作者：
Ramjee, Gita
中科院分区：
文献类型：
--
作者：
Gappoo, Sharika;Montgomery, Elizabeth T.;Ramjee, Gita
背景：迫切需要确定妇女可以自己发起的新的艾滋病毒预防方法，特别是在高流行环境中。艾滋病毒预防试验必须设计大样本量和/或大量随访期，以确保有足够的统计能力来衡量产品的有效性。本文描述了改善非洲生殖健康方法（MIRA）试验的出勤率、错过访问的原因以及用于保留参与者的策略；并研究了留住女性的人口和行为预测因素。方法：HIV阴性，性活跃的女性被纳入津巴布韦和南非的MIRA试验。一旦登记，女性预计每两周访问一次诊所，此后每季度访问一次，持续12至24个月。提出了特定访问保留率的表格，以及在执行期间为应对挑战而制定的保留率战略的描述性摘要。在STATA中创建了单变量和多变量逻辑回归模型，以检查保留与丢失随访的预测因子。结果：在三个站点中，津巴布韦、德班和约翰内斯堡的最终保留率分别为94%、93%和89%。这是通过对试验后半段的密集外联努力和所有工作人员的承诺实现的。每个网站都实施了几种保留策略。结论：通过增加工作人员的努力和资源，本试验取得了较高的保留率。社区参与对实现这些比率也至关重要。在试验设计期间应考虑保留试验参与者，并从一开始就实施。(C) 2009爱思唯尔公司版权所有。
Background: The identification of new HIV prevention methods that women can initiate themselves are urgently needed, particularly in high prevalence settings. HIV prevention trials must be designed with large sample sizes and/or substantial follow-up periods to ensure enough statistical power to measure product effectiveness. This paper describes the attendance rates of the Methods for Improving Reproductive Health in Africa (MIRA) trial, reasons for missed visits, and strategies used to retain participants; and examines demographic and behavioural predictors of retaining women.Methods: HIV negative, sexually active females were enrolled into the MIRA trial in Zimbabwe and South Africa. Once enrolled, women were expected to visit the clinic at 2 weeks and quarterly thereafter for 12 to 24 months. Tabulations of visit-specific retention rates are presented, along with a descriptive summary of retention strategies established prior to and in response to challenges incurred during implementation. Both univariate and multivariate logistic regression models were created in STATA to examine predictors of being retained vs. lost-to-follow-up.Results: At the three sites, the final retention rates were 94%, 93% and 89% for Zimbabwe, Durban and Johannesburg, respectively. This was achievable through intensive outreach efforts toward the latter part of the trial and a commitment from all staff. Each site implemented several retention strategies.Conclusion: The high retention rates were achievable in this trial through added staff efforts and resources. Community involvement was also crucial to achieve these rates. Retention of trial participants should be considered during trial design and implemented from the onset. (C) 2009 Elsevier Inc. All rights reserved.