HIV Prevention Intervention for Young Transgender Women

描述(由申请人提供)：这项研究的目的是测试针对16至24岁面临艾滋病毒感染或传播风险的年轻变性人妇女(YTW)的独特针对性降低艾滋病毒风险干预措施的有效性。有证据表明，变性人妇女的艾滋病毒流行率与其他高危群体一样高或更高(即25%)，再加上令人震惊的未被识别的感染率(即10%)，其中YTW(29岁及以下)的比例最大。这群年轻妇女的危险性行为和艾滋病毒感染率很高，这表明需要针对她们的独特情况制定全面的艾滋病毒预防方案。研究小组先前由疾控中心资助的一项初步研究表明，在这一群体中进行干预是可行的、可接受的和有效的。2008-2009年，目标人群(即青瓦台)成员在一个多学科研究小组的指导下，根据青瓦台的社会现实，牵头制定了以理论为导向的全面干预课程(即“生活技能”)。我们发现，研究人群的登记和保留是可行的(即，51名参与者在6个月内登记)，并且保留和课程出勤率都很高(在研究过程中保留了84%)。我们建议在两个美国主要城市进行三臂随机对照试验来测试这种干预措施，这些城市有很好的人群准入和研究经验。我们将招募375名年龄在16-24岁的有风险的YTW；五分之二的随机样本(N=150)将参加基于6个疗程的基于小组的和手动的生活技能干预；五分之二(N=150)将被随机分配到护理标准(SOC)控制条件；五分之一的样本将被随机分配到时间匹配的注意控制条件(N=75)，并以基于组的多会话形式接受标准的健康促进信息。所有三支部队都将接受艾滋病毒和性传播感染(衣原体和淋病)检测和检测前后的风险降低咨询(即，SOC)。将在基线、干预后4个月、8个月和12个月评估性风险我们的具体目标是：1)确定生活技能干预相对于SOC臂和时间匹配的注意控制对主要结果的有效性：YTW中16-24岁的无保护肛交行为(UA)的数量(前四个月)；2)检验性风险的改善在多大程度上受到干预的概念中介因素的影响：变性人的适应和融入、集体自尊/赋权、信息(艾滋病毒知识)、动机(态度、规范和安全性行为意图)和行为技能(与性伴侣讨论性行为和避孕套的使用、获得和使用避孕套)；探索性风险的降低是否与性风险行为的流行病学调节因素有关：年龄、种族/民族和心理社会因素。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 ARM中，我们将评估性危险行为的自然轨迹以及在12个月的随访期内YTW获得艾滋病毒和性传播感染(发病率)的情况。

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.