HIV/STD Prevention Program for African American Males

描述（由申请人提供）：所有种族/民族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，特别是对非洲裔美国男性（Kennedy等人，2007 a，B，c; Kennedy等人，审查中）。作为一项行动号召，一个研究人员合作小组提议进行一项为期四年的行为驱动的研究，以修改、实施和评估一项有前途的简短安全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岁的非洲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，实施和评估非洲裔美国男性避孕套推广计划的有效性。1.1.与对照组相比，随机分配到干预组的参与者是否会报告安全套使用频率的统计学显著增加和无保护性交（主要结局）的减少？1.2.干预是否会对次要结局产生统计学上显著的积极影响（例如，安全套使用自我效能、安全套使用决策平衡等）相对于对照组？1.3.次要结局是否会调节干预状态与安全套使用（主要结局）之间的关系？ 2.评估项目实施的特点及其与行为结果变化的关系。2.1.实现的精确度是多少？2.2.实施保真度的变化与主要结局的变化有何关系？在为期九个月的形成阶段，我们将与关键线人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，我们将从招募地点招募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局的有效性。假设30%的流失率（n=156），我们预计将收集完整的结果数据，通过音频计算机辅助自我访谈（ACASI）从约364名参与者超过12个月。此外，我们会进行性病的生物学评估，以验证参与者在所有评估点的性行为自我报告。这项拟议的研究是最近完成的NIH资助的R21（PI：Kennedy）的延伸，以开发，实施和试点非洲裔美国男性的简短避孕套推广计划（Kennedy et al.，2007 a，B，c; Kennedy等人，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合作伙伴组成的合作团队，以成功实施这个拟议的项目。

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.