AIDS. 2007 Apr;21 Suppl 2:S29-36. doi: 10.1097/01.aids.0000266455.03397.08.
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.
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.
Literature reviews, investigator experience, ethnographic study, pilot studies, and epidemiological studies were used to select the endpoints for the Trial.
Both biological and behavioral data will be obtained at baseline and 12 and 24 months 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.
回顾为美国国立精神卫生研究所（NIMH）的跨国艾滋病毒/性传播疾病预防合作试验设计行为和生物学结果测量指标所面临的挑战，并阐述选择这些指标的理由。
尽管已经制定了许多不同的循证预防方案，但很少在不同国家、文化和人群中进行评估。评估任何预防方法的普遍有效性时的一个问题是确定一套适用于不同环境和人群的共同结果测量指标。该试验旨在评估社区民意领袖干预措施是否可以在跨国和跨文化背景下适用于不同人群，并仍然保持其有效性。
采用文献综述、研究者经验、人种学研究、试点研究和流行病学研究来选择该试验的终点指标。
将在基线以及基线后12个月和24个月获取生物学和行为数据。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、非同居伴侣的无保护性行为的自我报告变化；（ii）性传播疾病（STD）的发病率，定义为病毒和细菌性传播疾病的综合指数。
