PS16-003, Evaluation of TransLife Center: A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection

减少发生性行为的变性妇女(TW)艾滋病毒感染差异的综合干预措施 由于这一群体是世界上风险最高、服务最少的群体之一，因此迫切需要男性 美国。这项拟议的研究项目的目标是评估当地开发的和潜在的 有效的干预，Translife Center(TLC)，它提供组合(即，生物医学，行为， 社会/结构)向艾滋病毒感染高危人群提供艾滋病毒预防服务，在文化上和 极易接近的肯定环境。TLC干预直接解决了 通过协调的筛查和服务模式在TW中促进健康，包括直接获得 TW最需要和要求的服务：就业、住房、法律和健康服务，以下是 健康概念模型的社会决定因素。到目前为止，还没有基于证据的艾滋病毒预防措施 疾病预防控制中心EBI简编中列出的TW干预措施(EBI)。拟议的研究将解决这一差距。 通过芝加哥之家和社会服务机构(Chicago House)的合作，一个历史悠久的 艾滋病毒/艾滋病服务提供者和艾滋病毒预防研究人员一直积极参与 制定针对TW的艾滋病毒预防干预措施。我们的经验表明，芝加哥之家的TLC 干预是可行的，目标人群可以接受，有200多名未感染艾滋病毒的TW参与 在过去三年的服务中，有证据表明干预对两者都有潜在的效果 减少性风险和促进健康。我们建议在一项单一的ARM试验中测试TLC干预 100名未感染艾滋病毒且性行为活跃的TW，年龄在18岁及以上，并在一年内评估干预效果 12个月期间，每隔6个月进行一次访问(基线、6个月、12个月)。所有参与者都将收到 护理标准艾滋病毒/性传播感染预防和检测服务、评估以及与暴露前预防的联系 (准备)，如图所示。我们将通过以下目标对TLC干预进行评估：目的1)确定 TLC干预前后对主要结果的效果：无套肛交行为的数量 由PrEP提供保护。1a)评估干预暴露之间的剂量反应关系 暴露于关于减少初级卫生保健的具体组成部分(即就业、住房、法律和健康) 结果。1b)评估干预措施对保护进程的调解效果(性别肯定、 集体自尊、社会支持)理论上会随着干预暴露的增加而增加；目的2)来检验 通过对20名TLC参与者和10名TLC参与者进行半结构化访谈，获得干预实施经验 芝加哥众议院的工作人员。目的3)探索性目标：3A)描述PrEP适应症的发展轨迹， 在12个月的随访期内对社区样本的摄取、保留和依从性 评估TLC干预对PrEP连续护理的影响。3b)探索削减 艾滋病毒风险与流行病学相关的调节因素有关，包括年龄和种族/族裔。

Combination interventions to reduce disparities in HIV infection for transgender women (TW) who have sex with men are sorely needed, as this population is one of the highest risk and most underserved groups in the United States. The goal of this proposed research project is to evaluate a locally developed and potentially effective intervention, the TransLife Center (TLC), which provides combination (i.e., biomedical, behavioral, social/structural) HIV prevention services to adult TW at high risk for HIV infection, in a culturally specific and highly accessible affirming environment. The TLC intervention directly addresses the structural barriers to health promotion among TW through a coordinated screening and service model, including direct access to services most needed and requested by TW: employment, housing, legal, and health services, following a social determinants of health conceptual model. To date there are no evidence-based HIV prevention interventions (EBIs) for TW listed in the CDC compendium of EBIs. The proposed study will address this gap through collaboration between Chicago House and Social Service Agency (Chicago House), a long-standing HIV/AIDS service provider and HIV prevention researchers who have been actively engaged in the development of HIV prevention interventions for TW. Our experience suggests that Chicago House's TLC intervention is feasible and acceptable to the target population, with over 200 HIV-uninfected TW participating in services over the past three years and evidence suggesting potential efficacy of the intervention for both sexual risk reduction and health promotion. We propose to test the TLC intervention in a single arm trial among 100 HIV-uninfected and sexually active TW, ages 18 and older, and evaluate intervention effectiveness over a 12-month period with visits at 6-month intervals (baseline, 6-months, 12-months). All participants will receive standard-of-care HIV/STI prevention and testing services, assessment and linkage to pre-exposure prophylaxis (PrEP), as indicated. We will evaluate the TLC intervention via the following aims: AIM 1) To determine the pre-post efficacy of the TLC intervention on the primary outcome: number of condomless anal sex acts without protection by PrEP. 1a) To assess the dose response relationship between intervention exposure as well as exposure to specific components (i.e., employment, housing, legal, and health) on reductions in the primary outcome. 1b) To assess mediation of intervention effects on protective processes (gender affirmation, collective self-esteem, social support) theorized to increase with intervention exposure; AIM 2) To examine intervention implementation experiences through semi-structured interviews with 20 TLC participants and 10 Chicago House staff members. AIM 3) Exploratory Aims: 3a) To describe the trajectory of PrEP indication, uptake, retention and adherence in the community-based sample over a 12-month follow-up period and evaluate the impact of the TLC intervention on the PrEP continuum of care. 3b) To explore whether reductions in HIV risk are associated with epidemiologically-linked moderators including age and race/ethnicity.