HIV/STD Prevention Program for African American Males

说明(由申请人提供)：所有种族/族裔群体的年轻人普遍使用避孕套仍然是一个巨大的公共卫生挑战，特别是对非裔美国男性(Kennedy等人，2007a，b，c；Kennedy等人，审查中)。作为行动的号召，一个合作的研究团队提议进行一项为期四年的行为驱动型研究，以修改、实施和评估一项有前景的简短避孕套推广计划的有效性，该计划在芝加哥南区12个社区中心18-24岁的非裔美国男性中进行了一项双臂随机试验。因此，我们提出了以下具体目标和相关的研究问题： 1.修改、实施和评估针对非裔美国男性的避孕套推广计划的效果。1.1.随机分配到干预组的参与者是否会报告说，与分配给对照组的人相比，使用避孕套的频率在统计学上显著增加，而无保护措施的性行为(主要结果)减少？干预对二次结果(如避孕套使用自我效能感、避孕套使用决策平衡等)是否会产生统计学上显著的积极影响？相对于对照组？1.3。次要结果是否会在干预状态和避孕套使用之间的关系(主要结果)之间起中介作用？ 2.评估项目实施的特点及其与行为结果变化的关系。2.1.实施的保真度是多少？2.2。执行保真度的变化与主要结果的变化有何关系？在为期九个月的形成阶段，我们将对主要信息者和目标人群进行一系列定性访谈，以修改我们现有的计划。在接下来的16个月里，我们将从我们的招聘网站招募520名研究参与者，以实施干预和比较计划，并评估干预计划对一系列主要和次要结果的效果。假设流失率为30%(n=156)，我们希望在12个月内通过音频计算机辅助自访(ACASI)从大约364名参与者中收集完整的结果数据。此外，我们将进行性病的生物学评估，以验证参与者在所有评估点对性行为的自我报告。这项拟议的研究是最近完成的NIH资助的R21(PI：Kennedy)的扩展，以开发、实施和试点针对非裔美国男性的简短避孕套推广计划(Kennedy等人，2007a，b，c；Kennedy等人，正在审查中)。我们已经组建了一个由经验丰富的调查人员和研究伙伴组成的协作团队，以成功实施这一拟议项目。

DESCRIPTION (provided by the applicant): Common use of condoms by young adults across all racial/ethic groups remains a formidable public health challenge, especially for African American males (Kennedy et al., 2007a,b,c; Kennedy et al., under review). As a call to action, a collaborative team of researchers proposes to conduct a four-year behavioral-driven research study to modify, implement and evaluate the efficacy of a promising brief condom promotion program in a two-arm randomized trial among African American males 18-24 years from 12 community centers on Chicago's South Side. Accordingly, we propose the following specific aims and related set of research questions: 1. Modify, implement, and assess the efficacy of a condom promotion program for African American males. 1.1. Will participants randomly assigned to the intervention report a statistically significant increase in the frequency of condom use and decrease in unprotected sexual intercourse (primary outcomes) relative to those assigned to the comparison group? 1.2. Will the intervention produce statistically significant positive effects on secondary outcomes (e.g., condom use self-efficacy, condom use decisional balance, etc.) relative to the comparison group? 1.3. Will the secondary outcomes mediate the relationship between intervention status and condom use (the primary outcome)? 2. Assess characteristics of program implementation and its relationship to changes in behavioral outcomes. 2.1. What was the level of implementation fidelity? 2.2. How is variation in implementation fidelity related to change in primary outcomes? For a nine-month formative phase, we will conduct a series of qualitative interviews with key informants and the target population to modify our existing program. Over the next 16 months, we will recruit 520 study participants from our recruitment sites to implement the intervention and comparison programs and assess the efficacy of the intervention program on a series of primary and secondary outcomes. Assuming 30% attrition rate (n=156), we expect to collect complete outcome data via Audio Computer Assisted Self Interview (ACASI) from about 364 participants over 12-months. In addition, we will conduct biological assessment of STDs to validate participants' self-reports on sexual behaviors at all assessment points. This proposed study is an extension of a recently completed NIH-funded R21 (PI: Kennedy) to develop, implement, and pilot a brief condom promotion program for African American males (Kennedy et al., 2007a,b,c; Kennedy et al., under review). We have assembled a collaborative team of experienced investigators and research partners to successfully implement this proposed project.