Community-based combination HIV prevention in Tanzanian women at heightened risk

描述（由申请人提供）：联合艾滋病毒预防在减少疾病负担方面显示出重大前景。为了最大限度地发挥其有效性，联合预防必须针对特定背景和人群进行调整。从全球艾滋病毒流行开始，女性性工作者（FSW）就被发现处于更高的感染风险之中。最近，性工作在艾滋病毒持续传播动态中的作用在普遍流行病中得到了更明确的确立，而以前对关键人群的作用关注有限。现在人们普遍认为，性工作者更易受伤害与社会和结构性因素有关，包括他们经常面临的严重耻辱、歧视和暴力，以及他们生活和工作的不安全环境。众所周知，这些因素限制了保护性性行为和参与艾滋病毒检测、护理和治疗服务。在南亚和拉丁美洲，以社区为基础的全面艾滋病毒预防办法已被证明是有效的，这些办法解决了上述性工作者感染艾滋病毒的社会和结构脆弱性。然而，在艾滋病毒影响最大的撒哈拉以南非洲地区，没有系统的努力来开发和评估FSW中基于社区的艾滋病毒预防组合的可行性和有效性。我们建议在坦桑尼亚伊林加的FSW中进行一项以社区为基础的联合HIV预防干预的双臂II期社区随机对照试验。该模型是在先前的形成性研究和绘图的基础上开发的，并利用了正在进行的研究基础设施。综合方案将包括综合的生物医学、行为和结构组成部分：（1）移动的艾滋病毒检测和减少风险咨询;（2）服务导航，以便利获得治疗和继续护理;（3）对艾滋病毒临床护理提供者进行敏感性培训;（4）短信，以促进坚持护理和抗逆转录病毒疗法;（5）基于场所的同伴教育和分发避孕套;及（6）社区救助中心，以促进凝聚力及集体行动，减少污名化及歧视。我们寻求建立关键结果的基本比率，包括艾滋病毒发病率和病毒载量抑制，检查干预的社会结构和行为途径，评估可行性，可接受性和安全性，并记录初步有效性。如果发现安全性、可行性、可接受性和初步有效性的令人信服的迹象，研究结果将为FSW中以社区为基础的艾滋病毒预防组合的第一个III期随机对照试验提供信息。

DESCRIPTION (provided by applicant): Combination HIV prevention demonstrates significant promise in reducing burden of disease. To maximize its effectiveness combination prevention must be tailored to a given context and population. From the beginning of the global HIV epidemic, female sex workers (FSWs) have been found to be at heightened risk for infection. More recently the role that sex work plays in ongoing HIV transmission dynamics has been more clearly established in generalized epidemics, where previously limited attention was paid to the role of key populations. The greater vulnerability of FSWs is now widely understood to be associated with social and structural factors including the intense stigma, discrimination and violence they often face and the unsafe environments in which they live and work. These factors are known to limit both protective sexual behaviors and engagement in HIV testing, care and treatment services. Comprehensive, community-based HIV prevention approaches addressing the aforementioned social and structural vulnerabilities to HIV infection among FSWs have been shown to be effective in South Asia and in Latin America. However, in sub-Saharan Africa where the impact of HIV is the greatest, no systematic efforts to develop and evaluate the feasibility and effectiveness of community-based combination HIV prevention among FSWs has occurred. We propose to conduct a two-arm Phase II community randomized controlled trial of a community-based combination HIV prevention intervention among FSWs in Iringa, Tanzania. The model was developed on the basis of prior formative research and mapping and utilizes an ongoing research infrastructure. The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity trainin for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop- in-center to promote cohesion and collective action to reduce stigma and discrimination. We seek to establish base rates of key outcomes including HIV incidence and viral load suppression, examine the socio-structural and behavioral pathways of the intervention, assess feasibility, acceptability and safety, and document preliminary effectiveness. Should compelling indications of safety, feasibility, acceptability and initial effectiveness be found, study results will informthe first Phase III RCT of community-based combination HIV prevention among FSWs.