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

描述（由申请人提供）：美国疾病控制与预防中心宣布，艾滋病在美国是非裔美国人的“紧急状态”。在性病诊所就诊的青少年男性是非洲裔美国人感染艾滋病毒的重要人群，但往往被忽视。尽管在这一人群中，性病感染（以及随后的感染）率极高，但有效的临床干预措施，特别是为减少性病/艾滋病的性风险行为而设计的，还没有开发/传播。最近的一项干预试验（由克罗斯比博士进行）证明了一项简短的、基于临床的干预措施的有效性，该措施旨在防止18至29岁的非裔美国男性随后感染性病。拟议的研究将测试这种干预（以改良形式）在减少非洲裔美国青少年（15至20岁）的性传播感染发生率方面的功效。主要假设是，随机接受干预的青少年在2个月和6个月的随访评估中（以及通过医疗记录审查进行的12个月的随访），与接受同等注意力控制条件的青少年相比，实验室确诊的性传播感染的发病率较低。青少年（N = 840）将从位于南方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，青少年将根据他们在阴茎模型上使用避孕套的能力进行评分，然后要求他们捐献尿液样本进行性病检测。标本将采用核酸扩增法检测沙眼衣原体、淋病奈瑟菌和阴道衣原体。然后通过隐藏分配技术实现随机化。青少年将随机立即接受：1)由外行健康顾问提供的简短（60分钟）基于理论的一对一互动干预，或2)注意力等效控制条件。评估将在入组后2个月和入组后6个月再次进行。登记12个月后将进行医疗记录审查，以比较随机分组的青少年之间的诊所报告发病率。如果这些青少年的性传播感染发生率能够像之前对18 - 29岁非裔美国男性的研究那样大幅降低（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/性病方面的种族差异。推而广之，我们认为他们的伴侣（通常是非裔美国少女）也会受益。由于我们的计划是为了便于实施而设计的，因此传播和翻译问题的数量将大大减少，从而大大促进了将研究成果转化为实践的过程。公共卫生相关性：拟议的疗效试验测试了一种弥合研究与实践之间差距的创新方法。通过为参加性病诊所的非裔美国男性青少年提供一个简短的、基于临床的艾滋病/性病预防项目，该研究将首次证明，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减少。鉴于美国疾病控制与预防中心最近宣布艾滋病是非洲裔美国人的“紧急状态”，对非洲裔美国青少年男性的关注也相当及时。

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.