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

PS16-003，TransLife 中心评估：针对艾滋病毒感染高危跨性别女性的本地开发的联合预防干预措施

• 批准号: 9753066
• 负责人: Lisa Mary Kuhns
• 金额: $ 40万
• 依托单位: CHICAGO HOUSE AND SOCIAL SERVICE AGENCY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2020-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753066
• 关键词: PS16; 003; Evaluation; TransLife; Center

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.

减少有性行为的跨性别女性 (TW) 艾滋病毒感染差异的联合干预措施 迫切需要与男性合作，因为这一人群是世界上风险最高、服务最匮乏的群体之一 美国。这个拟议的研究项目的目标是评估当地开发的和潜在的 TransLife 中心 (TLC) 提供有效的干预措施，该中心提供组合（即生物医学、行为、 社会/结构）为艾滋病毒感染高危成年台湾人提供艾滋病毒预防服务，以文化特定和 高度可及的肯定环境。 TLC 干预直接解决了结构性障碍 通过协调的筛查和服务模式，包括直接获取信息，在台湾地区促进健康 台湾最需要和要求的服务：就业、住房、法律和医疗服务， 健康的社会决定因素概念模型。迄今为止，尚无基于证据的艾滋病毒预防方法 CDC EBI 纲要中列出的针对 TW 的干预措施 (EBI)。拟议的研究将解决这一差距 通过芝加哥之家 (Chicago House) 与社会服务机构 (Chicago House) 之间的合作， 积极从事艾滋病防治工作的艾滋病毒/艾滋病服务提供者和艾滋病毒预防研究人员 为台湾制定艾滋病毒预防干预措施。我们的经验表明，Chicago House 的 TLC 干预措施可行且为目标人群所接受，有超过 200 名未感染艾滋病毒的台湾人参与 过去三年的服务和证据表明干预措施对两者的潜在功效 减少性风险和促进健康。我们建议在单臂试验中测试 TLC 干预 100 名未感染 HIV 且性活跃的 TW，年龄 18 岁及以上，并评估干预效果 12 个月期间，每 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 标准护理艾滋病毒/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 (PrEP)，如所示。我们将通过以下目标评估 TLC 干预： AIM 1) 确定 TLC 干预对主要结果的前后效果：无安全套肛交行为的数量 PrEP 的保护。 1a) 评估干预暴露与剂量反应之间的关系 特定组成部分（即就业、住房、法律和健康）对初级教育减少的影响 结果。 1b) 评估干预对保护过程的影响（性别肯定、 集体自尊、社会支持）理论上会随着干预暴露而增加；目标 2) 检查 通过对 20 名 TLC 参与者和 10 名 TLC 参与者进行半结构化访谈，了解干预实施经验 芝加哥之家工作人员。目标 3) 探索性目标： 3a) 描述 PrEP 适应症的轨迹， 在 12 个月的随访期内对基于社区的样本的吸收、保留和坚持 评估 TLC 干预对 PrEP 连续护理的影响。 3b) 探讨是否减少 HIV 风险的增加与流行病学相关的调节因素有关，包括年龄和种族/民族。