HIV Prevention Intervention for Young Transgender Women

描述（由申请人提供）：本研究的目的是测试一种独特的有针对性的艾滋病毒风险降低干预措施对16至24岁有艾滋病毒感染或传播风险的年轻变性女性（YTW）的有效性。有证据表明，跨性别妇女的艾滋病毒感染率与其他高危人群一样高（即25%）或更高（即25%），同时还有令人吃惊的未被识别的感染率（即10%），其中在YTW（29岁及以下）中所占比例最大。高风险的性行为和艾滋病毒感染率在这群年轻女性中很高，这表明需要针对她们独特的情况制定全面的艾滋病毒预防方案。研究小组先前进行的一项由cdc资助的试点研究表明，对这一群体进行干预是可行的、可接受的和有效的。2008-2009年，在一个多学科研究团队的指导下，目标人群（即青年旅社）的成员根据青年旅社的社会现实，领导开发了一个全面的、理论驱动的干预课程（即“生活技能”）。我们发现研究人群的登记和保留是可行的（即在6个月内登记了51名参与者），保留率和会议出勤率都很高（在研究过程中保留率为84%）。我们建议在美国两个主要城市进行一项三组随机对照试验来测试这种干预措施，这些城市具有良好的人口接触和研究经验。我们将招募375名年龄在16-24岁的YTW高危人群；随机分配到干预组的五分之二的样本（N=150）将参加6次分组和手动生活技能干预；五分之二（N=150）将随机分配到标准护理（SOC）对照条件；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），并以分组为基础的多时段格式接收标准的健康促进信息。所有三个组都将接受艾滋病毒和性传播感染（衣原体和淋病）检测和检测前后降低风险咨询（即SOC）。性风险将在基线、干预后4个月、8个月和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手臂和时间匹配的注意力控制相比对主要结果的有效性：16-24岁的YTW中（前4个月）无保护肛交行为（UAS）的数量；2)检查干预的概念中介对性冒险行为改善的调节程度：跨性别适应和融合、集体自尊/赋权、信息（艾滋病毒知识）、动机（对安全性行为的态度、规范和意图）和行为技能（与性伴侣讨论性行为和安全套的使用、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子有关：年龄、种族/民族和社会心理因素。另一个探索性目的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方面，我们将在12个月的随访期间评估YTW中性风险行为的自然轨迹以及艾滋病毒和性传播感染（发病率）。

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.