HIV Prevention Intervention for Young Transgender Women

年轻跨性别女性的艾滋病毒预防干预

• 批准号: 8644925
• 负责人: Robert Garofalo
• 金额: $ 71.38万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-13 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8644925
• 关键词: 2-cyclopentyl-5-(5-isoquinolylsulfonyl)-6-nitro-1H-benzo(D)imidazole; AIDS prevention; Address; Age; Anal Sex; Anus; Attention; Attitude; Behavior Therapy; Behavioral; Caring; Centers for Disease Control and Prevention (U.S.); Chlamydia; Cities; Communities; Counseling; Development; Economics; Educational Curriculum; Employment; Enrollment; Ethnic Origin; Frequencies; Funding; Future; Gonorrhea; HIV; HIV Infections; HIV risk; Health Promotion; Housing; Incidence; Infection; Interdisciplinary Study; Intervention; Knowledge; Life; Link; Mediating; Mediator of activation protein; Monitor; Motivation; Outcome; Participant; Pilot Projects; Population; Population Decreases; Population Study; Prevalence; Prevention program; Preventive Intervention; Psychosocial Factor; Race; Randomized; Randomized Controlled Trials; Recruitment Activity; Research; Risk; Risk Reduction; Sampling; Secure; Sexual Partners; Target Populations; Testing; Time; Unsafe Sex; Visit; Woman; Work; arm; base; burden of illness; community based participatory research; condoms; effective intervention; efficacy testing; empowerment; experience; follow-up; high risk; high risk sexual behavior; member; post intervention; prevent; primary outcome; safer sex; self esteem; sex; sex risk; sexual risk taking; skills; social; transgender; transmission process; trend; young woman

DESCRIPTION (provided by applicant): The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 24, at risk for HIV acquisition or transmission. Evidence indicates that transgender women have HIV prevalence rates as high as or higher than other high risk groups (i.e., >25%), compounded by a startling rate of unrecognized infection (i.e., >10%), with the largest percentage among YTW (ages 29 and younger). High rates of risky sexual behavior and HIV infection among this population of young women indicate a need for comprehensive HIV prevention programs targeted to their unique circumstances. A prior CDC-funded pilot study conducted by the study team suggests that intervening among this group is feasible, acceptable, and efficacious. In 2008-2009, members of the target population (i.e., YTW), with guidance from a multidisciplinary research team, led the development of a holistic, theoretically-driven intervention curriculum (i.e., "Life Skills") grounded in the social realities of YTW. We found that enrollment and retention of the study population was feasible (i.e., 51 participants enrolled in 6 months) and both retention and session attendance were high (84% retained over the course of the study). We propose to test this intervention in a three-arm randomized controlled trial in two major U.S. cities with excellent access to and research experience with the population. We will enroll 375 at risk YTW, ages 16-24; two-fifths of the sample (N=150) randomized to the intervention will participate in the 6-session group-based and manualized Life Skills intervention; two-fifths (N=150) will be randomized to the standard-of-care (SOC) control condition; and one- fifth will be randomized to the time-matched attention control condition (N=75) and receive standard health promotion information in a group-based multi-session format. All three arms will receive HIV and STI (Chlamydia and gonorrhea) testing and pre-posttest risk reduction counseling (i.e., SOC). Sexual risk will be assessed at baseline, 4, 8 and 12 months post-intervention Our specific aims are: 1) to determine the efficacy of the Life Skills intervention in comparison to a SOC arm and a time-matched attention control on the primary outcome: number of unprotected anal sex acts (UAS) (in the previous four months) among YTW, ages 16-24; and 2) to examine the degree to which improvements in sexual risk taking are mediated by the conceptual mediators of the intervention: transgender adaptation and integration, collective self-esteem/empowerment, information (HIV knowledge), motivation (attitudes, norms, and intentions for safer sex), and behavioral skills (discussing sex and condom use with sexual partners, acquiring and using condoms); and to explore whether reductions in sexual risk are associated with epidemiologically-linked moderators of sexual risk behavior: age, race/ethnicity, and psychosocial factors. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample; in the SOC arm, we will assess the natural trajectory of sexual risk behavior and the acquisition of HIV and STIs (incidence rate) in YTW over a 12-month follow-up period.

描述（由申请人提供）：本研究的目的是测试针对 16 至 24 岁、有艾滋病毒感染或传播风险的年轻变性女性 (YTW) 的独特针对性艾滋病毒风险降低干预措施的有效性。有证据表明，跨性别女性的艾滋病毒感染率与其他高危人群一样高或更高（即 >25%），而且未识别的感染率令人震惊（即>10%），其中跨性别女性的比例最高（ 29 岁及以下）。这群年轻女性中危险性行为和艾滋病毒感染率很高，表明需要针对她们的独特情况制定全面的艾滋病毒预防计划。研究小组先前进行的一项由疾病预防控制中心资助的试点研究表明，对这一群体进行干预是可行的、可接受的且有效的。 2008-2009年，目标人群（即YTW）成员在多学科研究团队的指导下，主导开发了基于社会现实的整体、理论驱动的干预课程（即“生活技能”）。 YTW。我们发现研究人群的注册和保留是可行的（即 6 个月内注册了 51 名参与者），并且保留率和会议出席率都很高（在研究过程中保留了 84%）。我们建议在美国两个主要城市进行三臂随机对照试验来测试这种干预措施，这两个城市拥有良好的人群接触和研究经验。我们将招募 375 名年龄在 16-24 岁之间的高危人群；随机分配干预组的五分之二样本（N = 150）将参加为期 6 次的基于小组的手动生活技能干预；五分之二 (N=150) 将被随机分配到护理标准 (SOC) 控制条件；五分之一的人将被随机分配到时间匹配的注意力控制条件（N=75），并以基于小组的多会话形式接收标准的健康促进信息。所有三个组都将接受 HIV 和 STI（衣原体和淋病）检测以及检测前风险降低咨询（即 SOC）。性风险将在基线、干预后 4、8 和 12 个月进行评估 我们的具体目标是：1) 确定生活技能干预与 SOC 组和时间匹配注意力控制对主要结果的比较的有效性：16-24 岁 YTW 中无保护肛交行为 (UAS) 的数量（过去四个月）； 2) 检查干预的概念中介因素对性冒险行为改善的程度：跨性别适应和融合、集体自尊/赋权、信息（艾滋病毒知识）、动机（态度、规范和意图）安全性行为）和行为技能（与性伴侣讨论性和安全套的使用，获取和使用安全套）；并探讨性风险的降低是否与流行病学相关的性风险行为调节因素有关：年龄、种族/民族和社会心理因素。另一个探索性目标是描述社区招募样本中艾滋病毒和性传播感染的流行情况；在 SOC 部门，我们将评估 YTW 在 12 个月的随访期内性危险行为的自然轨迹以及 HIV 和 STI 的感染（发病率）。