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Challenges and processes of selecting outcome measures for the NIMH Collaborative HIV/STD Prevention Trial.

机译：NIMH HIV / STD预防性合作试验选择结果指标的挑战和过程。

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摘要

OBJECTIVE: To review the challenges of designing behavioral and biological outcome measures for the multinational NIMH Collaborative HIV/STD Prevention Trial and provide the rationale for selecting these measures. DESIGN: Although many different evidence-based prevention programmes have been developed, few have been evaluated in different countries, cultures, and populations. One issue in evaluating the generalized efficacy of any prevention approach is to identify a set of common outcome measures useful across diverse settings and peoples. The Trial is designed to evaluate whether the community popular opinion leader intervention can be adapted cross-nationally and cross-culturally for different populations and still retain its efficacy. METHODS: Literature reviews, investigator experience, ethnographic study, pilot studies, and epidemiological studies were used to select the endpoints for the Trial. RESULTS AND CONCLUSION: Both biological and behavioral data will be obtained at baseline and 12 and 24months post-baseline. Communities that receive the intervention will be compared with matched control communities on two primary outcomes: (i) a change in self-reported unprotected sexual acts with non-spousal, non-live-in partners; and (ii) the incidence of sexually transmitted disease (STD), defined as a composite index of viral and bacterial STD.
机译：目的：回顾为跨国NIMH HIV / STD预防性合作试验设计行为和生物学结果指标的挑战，并为选择这些指标提供依据。设计：尽管已经开发了许多不同的基于证据的预防计划，但在不同的国家，文化和人群中却很少进行评估。评估任何预防方法的普遍效力时，一个问题是确定一套适用于不同环境和人群的共同结果指标。该试验旨在评估社区民意领袖干预是否可以针对不同人群进行跨国和跨文化调整，并且仍然保持其有效性。方法：文献回顾，研究者的经验，人种学研究，试点研究和流行病学研究用于选择试验的终点。结果与结论：生物学和行为学数据都将在基线以及基线后12和24个月获得。接受干预的社区将与匹配的对照社区在两个主要结果上进行比较：（i）与非配偶，非住家伴侣一起自我报告的未受保护的性行为发生变化; （ii）性传播疾病（STD）的发生率，定义为病毒和细菌性传播疾病的综合指数。

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