A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males

描述(由申请者提供)：美国疾病控制和预防中心宣布，相对于非裔美国人，艾滋病在美国处于“紧急状态”。去性病诊所就诊的青少年男性是非洲裔美国人中一个重要但往往被忽视的群体，他们有感染艾滋病毒的风险。尽管这一人群的STD获得率(以及随后的感染率)极高，但还没有制定/传播专门为减少他们的性病/艾滋病毒的性危险行为而设计的基于诊所的有效干预措施。最近的一项干预试验(由克罗斯比博士进行)证明了一种短暂的、以临床为基础的干预措施的有效性，该干预措施旨在防止18至29岁的非裔美国男性随后感染性病。这项拟议的研究将测试这种干预(以改进的形式)在降低非裔美国青少年(15至20岁)性传播感染发病率方面的有效性。基本假设是，与接受同等注意力控制条件的青少年相比，随机接受干预的青少年在2个月和6个月的随访评估(以及通过医疗记录审查进行的12个月随访)中实验室确认的性传播感染的发生率较低。青少年(N=840人)将从位于南部城市地区的一家公共资助的性病诊所招募。在完成A-CASI评估后，青少年将根据他们为阴茎模型使用避孕套的能力进行评级，然后要求他们捐赠尿样进行性传播感染检测。将使用核酸扩增分析对标本进行沙眼衣原体、淋球菌和阴道毛滴虫的检测。然后将通过隐藏分配技术来实现随机化。青少年将被随机分组，立即接受：1)由非专业健康顾问提供的简短(60分钟)基于理论的、一对一的互动干预；或2)相当于注意力的控制条件。评估单元将在注册后2个月和注册后6个月再次进行。登记后12个月将进行医疗记录审查，以比较随机分组青少年之间的临床报告发病率。如果这群青少年中的性传播感染发病率能够像之前对18至29岁的非裔美国人男性进行的研究发现的那样大幅降低(相对差异百分比=36.7)，那么对非裔美国青少年男性的公共卫生意义将大大有助于纠正非裔美国青少年男性在艾滋病毒/性传播疾病方面的种族差异。推而广之，我们建议他们的伴侣(通常是非裔美国青少年女性)也将受益。由于我们的计划旨在便于实施，传播和翻译问题的数量将大大减少，从而极大地促进将研究转化为实践的过程。公共卫生相关性：拟议的功效试验测试了一种弥合研究与实践之间差距的创新方法。通过向在性病诊所就诊的非裔美国青少年男性提供简短的、以诊所为基础的艾滋病毒/性传播疾病预防计划，这项研究将首次证明，青少年的性风险行为可以在不花费过多时间和资源的情况下得到减少。考虑到疾控中心最近宣布艾滋病对非裔美国人来说是“紧急状态”，对非裔美国青少年男性的关注也是相当及时的。

DESCRIPTION (provided by applicant): The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US relative to African Americans. Teen males attending STD clinics are one important, yet often neglected, population of African Americans at risk of HIV acquisition. Despite extremely high rates of STD acquisition (and subsequent infection) among this population, effective clinic-based interventions specifically designed to reduce their sexual risk behavior for STD/HIV have not been developed/disseminated. A recent intervention trial (conducted by Dr. Crosby) demonstrated the efficacy of a brief, clinic-based, intervention designed to prevent subsequent STI acquisition among African American males 18 to 29 years of age. The proposed study will test the efficacy this intervention (in modified form) to reduce STI incidence among African American teen (15 to 20 years old). The primary hypothesis is that teens randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STIs at 2 and 6-month follow-up assessments (as well as 12-month follow-up conducted by a medical records review) compared to those receiving an attention-equivalent control condition. Teens (N = 840) will be recruited from a publicly-funded STD clinic located in an urban area of the South. After completing an A-CASI assessment, teens will be rated on their ability to apply condoms to a penile model and then asked to donate a urine specimen for STI testing. Specimens will be tested for C. trachomatis, N. gonorrhoeae, and T. Vaginalis using nucleic acid amplification assays. Randomization will then be achieved by a concealment of allocation technique. Teens will be randomized to immediately receive: 1) a brief (60 minute) theory-based, one-on-one, interactive intervention delivered by a lay health advisor or 2) an attention equivalent control condition. The assessment battery will be repeated 2 months subsequent to enrollment and again 6 months after enrollment. A medical records review will be conducted 12 months after enrollment to compare clinic reported incidence rates between the randomized groups of teens. If incidence of STIs in this population of teens can be decreased as substantially as was found in the previous study of 18 to 29 year-old African American males (percent relative difference = 36.7), the public health significance for African American teen males will substantially contribute to rectify the racial disparity in HIV/STD experienced by African American teen males. By extension, we suggest that their partners (typically African American teen females) will also benefit. Because our program is designed for ease of implementation, the number of dissemination and translation issues will be greatly minimized thereby greatly facilitating the process of translating research into practice. PUBLIC HEALTH RELEVANCE: The proposed efficacy trial tests an innovative method of bridging the gap between research and practice. By providing a brief, clinic-based, HIV/STD prevention program to African American teen males attending an STD clinic, the study will be the first to demonstrate that teen's sexual risk behavior can be reduced without excessive time and resources. The focus on African American teen males is also quite timely given the recent declaration by CDC that AIDS is a "state of emergency" for African Americans.