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

对坦桑尼亚高危妇女进行社区艾滋病毒综合预防

• 批准号: 8728432
• 负责人: DEANNA L KERRIGAN
• 金额: $ 60.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-25 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8728432
• 关键词: AIDS prevention; Address; Adherence; Adult; Affect; Africa South of the Sahara; Anti-Retroviral Agents; Area; Asia; Attention; Behavioral; Caring; Communities; Counseling; Country; Data Collection; Discrimination; Drops; Education; Effectiveness; Ensure; Environment; Epidemic; Face; Female; Gender Role; Goals; HIV; HIV Infections; HIV risk; Health Services Accessibility; Human immunodeficiency virus test; Incidence; Infection; Intervention; Intervention Studies; Latin America; Life; Maps; Mediating; Meta-Analysis; Methods; Modeling; Outcome; Outcome Study; Pathway interactions; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Play; Population; Positioning Attribute; Prevalence; Prevention; Prevention approach; Preventive Intervention; Provider; Public Health; Randomized; Randomized Controlled Trials; Research; Research Design; Research Infrastructure; Risk; Risk Reduction; Role; Safety; Services; Sex Behavior; Signal Transduction; Tanzania; Testing; Text; Time; Treatment Efficacy; Update; Violence; Viral Load result; Woman; Work; arm; attributable mortality; base; burden of illness; clinical care; cohesion; cohort; condoms; demographics; design; empowerment; peer; public health relevance; response; sensitivity training; sex; social; social stigma; systematic review; theories; transmission process

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.

描述（由申请人提供）：艾滋病毒联合预防在减轻疾病负担方面显示出巨大的前景。为了最大限度地提高其有效性，必须针对特定环境和人群制定组合预防措施。从全球艾滋病毒流行开始，女性性工作者 (FSW) 就被发现感染风险较高。最近，性工作在持续的艾滋病毒传播动态中所发挥的作用在普遍的流行病中得到了更明确的认识，而以前对重点人群的作用的关注有限。现在人们普遍认为，外劳的更大脆弱性与社会和结构因素有关，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，这些因素会限制保护性性行为以及艾滋病毒检测、护理和治疗服务的参与。在南亚和拉丁美洲，针对 FSW 感染艾滋病毒的上述社会和结构脆弱性的全面、基于社区的艾滋病毒预防方法已被证明是有效的。然而，在艾滋病毒影响最大的撒哈拉以南非洲地区，尚未开展系统性工作来开发和评估在女工中进行基于社区的艾滋病毒综合预防的可行性和有效性。我们建议在坦桑尼亚伊林加的 FSW 中开展一项双臂 II 期社区随机对照试验，研究基于社区的艾滋病毒预防联合干预措施。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。该组合方案将包括综合生物医学、行为和结构组成部分：(1) 移动艾滋病毒检测和降低风险咨询； (2) 服务导航，以方便获得治疗和保留护理； (3) 对艾滋病毒临床护理人员进行敏感性培训； (4) 促进坚持护理和抗逆转录病毒治疗的短信； （五）场内同伴教育和安全套发放； (6) 社区临时中心，以促进凝聚力和集体行动，减少耻辱和歧视。我们寻求建立包括艾滋病毒发病率和病毒载量抑制在内的关键结果的基本比率，检查干预措施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 中基于社区的艾滋病毒联合预防的第一个 III 期随机对照试验提供信息。