An Adaptive Randomized Evaluation of Nurse-led HIV Treatment Retention Interventions for Women Living with HIV

摘要 这项工作的目标是评估个人水平的有效性和潜在的人口水平的影响 分散的抗逆转录病毒治疗方案(DTP)和增强的社会资本，以实现持续的艾滋病毒 南非感染艾滋病毒的女性性工作者中的病毒抑制。FSW已经被证明是 在整个南部非洲背负不成比例的艾滋病毒负担，并面临艾滋病毒继续传播的高风险 鉴于在获得抗逆转录病毒治疗(ART)方面的差距。这些数据在撒哈拉以南地区是一致的 (SSA)，并强调迫切需要最大限度地减少妇女艾滋病病毒携带者在获得治疗方面的差距， 并在ART项目中以更好的吸收和保留来中断这些大的传播链。这个 拟议的研究将首先确定干预措施的最佳实施方法，以解决潜在的 通过对关键告密者、资助者和 政府。拟议目标的关键是描述权力下放的有效性和持久性 治疗方案和病例管理干预措施，以实现持续的病毒抑制使用适应性 通过顺序多分配随机试验(SMART)测试实施策略。这个 SMART将把南非德班感染艾滋病毒的782名未经病毒抑制的FSW随机分为两组 实验条件，包括获得分散治疗方案(DTP)或DTP和CASE 管理干预，并将通过多次随机对参与者进行为期18个月的跟踪调查 任务。并非所有FSW都将受益于或需要相同的干预或强度来实现持续 病毒抑制。事实上，对所有艾滋病毒携带者实施这些干预措施是不可行的。 因为这两个标准都不代表目前的护理标准。然而，这里提出的自适应实施战略 提供评估多组分、分级、干预强度的平台，以实现持续的病毒感染 压制。最后，我们将评估各种干预措施的成本效益，以 衡量这些方法的可持续性和可扩展性。这项研究将由约翰·霍普金斯大学进行 多伦多大学与结核病/艾滋病毒护理协会(THCA)和多伦多大学合作。我们会 利用THCA在德班运营的现有基础设施和服务交付系统，招募FSW与 艾滋病病毒参与试验。此外，THCA和THCA定期收集的健康评估数据 除了研究小组收集的数据外，还将使用国家卫生实验室服务来评估 这些妇女的治疗结果和病毒抑制。这项研究代表了一种 描述有效的战略，以改善不成比例的人群的艾滋病毒治疗结果 艾滋病毒的负担，并利用这些数据在普遍的 艾滋病病毒在南非流行。这项研究在描述方面与新的NIH优先事项是一致的 确保在ART中保留的最佳方法，并将差异降至最低。

ABSTRACT The goal of this work is to evaluate the individual-level effectiveness and potential population-level impact of decentralized anti-retroviral therapy programs (DTP) and enhanced social capital to achieve sustained HIV viral suppression among female sex workers (FSW) living with HIV in South Africa. FSW have been shown to bear disproportionate burden of HIV across Southern Africa and to be at high risk of onward HIV transmission given disparities in access to anti-retroviral therapy (ART). These data are consistent across Sub-Saharan Africa (SSA) and highlight an urgent need to minimize disparities in treatment access for FSW living with HIV, and interrupt these large chains of transmission with better uptake and retention in ART programs. The proposed study will first characterize optimal implementation methods for interventions that address underlying barriers to sustained viral suppression through qualitative interviews with key informants, benefactors, and the government. The crux of the proposed aims are to describe the effectiveness and durability of decentralized treatment programs and case management interventions to achieve sustained viral suppression using adaptive implementation strategies tested through a sequential multiple assignment randomized trial (SMART). The SMART will randomize 782 non-virally suppressed FSW living with HIV in Durban, South Africa to one of two experimental conditions including access to decentralized treatment programs (DTP) or DTP and case management interventions and will follow the participants for 18 months, through multiple randomization assignments. Not all FSW will benefit from - or need - the same intervention or intensity to achieve sustained viral suppression. Indeed, it would not be feasible to implement these interventions for all people living with HVI as neither represent current standard of care. However, the adaptive implementation strategies proposed here provide a platform to evaluate multicomponent, graduated, intervention intensity to achieve sustained viral suppression. Finally, we will evaluate the cost-effectiveness of the varying packages of interventions to measure sustainability and scalability of these approaches. The research will be conducted by Johns Hopkins University, in partnership with the TB/HIV Care Association (THCA) and the University of Toronto. We will utilize existing infrastructure and service delivery systems run by THCA in Durban to recruit FSW living with HIV to participate in the trial. Furthermore, health assessment data routinely collected by THCA and the National Health Laboratory Service will be used, in addition to data collected by the study team, to assess treatment outcomes and viral suppression among these women. The study represents an approach to characterize effective strategies to improve HIV treatment outcomes for a population disproportionately burdened by HIV, and leverage these data to model the cost-effectiveness in the context of the generalized HIV epidemic found in South Africa. This study is in line with the new NIH high priorities in terms of describing optimal approaches to ensure retention in ART and also minimizing disparities.