A Brief, Clinic-Based, Safer Sex Program for Young African American Men Who Have

一项针对年轻非裔美国男性的简短、基于临床的安全性行为计划

• 批准号: 8139497
• 负责人: Richard A Crosby
• 金额: $ 59.23万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8139497
• 关键词: Acquired Immunodeficiency Syndrome; African American; Age-Years; Anal Sex; Anus; Attention; Behavior; Biological Assay; Biological Markers; Centers for Disease Control and Prevention (U.S.); Chlamydia; Clinic; Clinical; Counseling; Development; Enrollment; Epidemic; Evidence based intervention; Funding; Future; Gays; Glare; Gonorrhea; HIV; Health; Heart; Hispanics; Incidence; Intervention; Laboratories; Methods; Modeling; National Institute of Mental Health; Outcome; Patient Self-Report; Phase; Population; Prevention program; Public Health; Randomized; Randomized Controlled Trials; Recruitment Activity; Relative (related person); Reporting; Research; Research Design; Risk; Sampling; Science; Sexual Partners; Swab; Syphilis; Target Populations; Testing; Translating; Trichomonas Infections; Urine; Vagina; Vulnerable Populations; arm; base; clinical practice; condoms; design; disorder prevention; effective intervention; efficacy testing; efficacy trial; evidence base; experience; flexibility; follow-up; high risk men; inclusion criteria; intervention effect; intervention program; male; men; men who have sex with men; novel; post intervention; prevent; programs; randomized trial; rectal; response; safer sex; sex; skills; standard of care; theories; therapy design; transmission process; two-arm study

DESCRIPTION (provided by applicant): The Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response. The crisis is especially dramatic in the South and it is now apparent that young African American men who have sex with men (MSM) are exceedingly likely to be infected. Unfortunately, the ever-expanding HIV epidemic experienced by this population has not been matched by equal attention to the development of efficacious prevention programs. The proposed project expands upon an NIMH-funded study (R21 MH066682-01A1) conducted by Dr. Crosby. His study of young African American males found that a brief, clinic-based intervention reduced incidence of subsequent STDs by about 50%. This brief, one-on-one, intervention program, known as Focus on the Future (FOF), is a practical alternative to group-based safer sex programs that can be difficult to translate from science into practice. The program is now classified as a "Best Practice" intervention by CDC. This project will begin with an extensive formative phase designed to adapt FOF to MSM. The adapted program will seek to "sexualize" condoms to promote their consistent and correct use to better prevent STD/HIV. The program is uniquely flexible in that it can be applied to MSM regardless of their HIV serostatus. The adapted program will be tested by a two-arm efficacy trail. We will recruit 750 MSM (15-29 years of age) from a publicly-funded STD clinic in Jackson MS. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free ditty bag of supplies from the "condom and lube buffet" (condom/lube distribution). The trial will test five hypotheses. Men randomized to receive the intervention will: 1) have a lower incidence rate of laboratory-confirmed STDs (by urine assay and rectal swab) at each of three follow-up assessments (3, 6, and 12 months) compared to controls; 2) report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to controls; 3) report having significantly fewer unprotected penetrative (penile-vaginal or penile-anal) sex partners between follow-up assessments compared to controls; 4) report having significantly fewer negative experiences with condom use between follow-up assessments compared to controls; and 5) demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition. Given the dearth of evidence-based options for intervening with this vulnerable population in clinical settings, demonstrated efficacy of the adapted program has important implications for public health efforts to prevent STD/HIV. The adapted FOF is also directly responsive to the President's National HIV/AIDS strategy, particularly with regards to the target population of this proposal. PUBLIC HEALTH RELEVANCE: The proposed efficacy trial will occur in Jackson, MS and it tests a brief, clinic-based, HIV/STD prevention program adapted specifically for young African American MSM. This program is based on a CDC-classified Evidenced-Based Intervention known as Focus on the Future. The randomized trial is designed with 3 follow-up assessments and it uses biomarker outcomes as well as a novel method of collecting self-reported outcomes.

描述(由申请者提供)：疾病控制和预防中心(CDC)将艾滋病称为非裔美国人的“健康危机”，并呼吁加强国家应对措施。这场危机在南方尤其严重，现在很明显，与男性发生性行为的年轻非裔美国人男性(MSM)极有可能被感染。不幸的是，这一人群经历的艾滋病毒流行不断扩大的同时，并没有对制定有效的预防方案给予同样的重视。拟议的项目是在克罗斯比博士进行的NIMH资助的研究(R21 MH066682-01A1)的基础上扩展的。他对年轻的非洲裔美国男性的研究发现，一项基于临床的简短干预措施将随后的性传播疾病的发病率降低了约50%。这个简短的、一对一的干预计划，被称为关注未来(FOF)，是以群体为基础的安全性行为计划的实用替代方案，这些计划可能很难从科学转化为实践。该项目现已被美国疾病控制与预防中心列为“最佳实践”干预项目。该项目将从一个广泛的形成阶段开始，旨在使FOF适应MSM。修改后的计划将寻求将避孕套“性化”，以促进避孕套的持续和正确使用，以更好地预防性病/艾滋病毒。该计划是唯一灵活的，因为它可以适用于MSM，无论他们的艾滋病毒血清状态。改编后的程序将通过双臂疗效试验进行测试。我们将从杰克逊的一家公共资助的性病诊所招募750名MSM(15-29岁)，将接受治疗的男性与接受控制条件的男性进行比较，控制条件包括从诊所接受标准护理咨询，以及从“避孕套和润滑油自助餐”(避孕套/润滑油分发)免费提供一小袋用品。这项试验将检验五个假设。随机接受干预的男性将：1)在3个月、6个月和12个月的每一次随访评估中，实验室确认的性传播疾病的发生率(通过尿液分析和直肠拭子)与对照组相比较低；2)在两次随访评估之间报告的无保护穿透性行为(阴茎-阴道或阴茎-肛门)与对照组相比显著减少；3)报告在两次跟踪评估之间无保护的穿透性伴侣(阴茎-阴道或阴茎-肛门)与对照组相比显著减少；4)报告在两次随访评估之间使用避孕套的负面经验与对照组相比显著减少；5)在为期12个月的研究中，与接受控制条件的人相比，使用避孕套的技能有了显著的改善。鉴于在临床环境中干预这一弱势人群的循证选择的缺乏，调整后的计划所展示的有效性对预防STD/HIV的公共卫生努力具有重要意义。调整后的论坛还直接响应总统的国家艾滋病毒/艾滋病战略，特别是关于这项提议的目标人口。 公共卫生相关性：拟议的有效性试验将在密歇根州杰克逊市进行，它测试一项专门针对年轻的非裔美国MSM的简短的、以诊所为基础的艾滋病毒/性传播疾病预防计划。这项计划是基于疾控中心分类的循证干预措施，称为关注未来。这项随机试验设计了3项后续评估，它使用了生物标记物的结果以及一种收集自我报告结果的新方法。