CHWs, mHealth, and Combination HIV Prevention in a Hotspot: A Randomized Trial

 描述（由申请人提供）：乌干达卡森塞罗是维多利亚湖上的一个渔业社区，是一个具有代表性的艾滋病毒“热点”，艾滋病毒流行率（44.3%）和发病率（约3.9/100 py）极高，但艾滋病毒服务利用率较低。卡森塞罗等热点地区可能在一般人群中传播和维持艾滋病毒，损害国家和区域艾滋病毒控制工作。总统艾滋病紧急救援计划、联合国艾滋病规划署和世卫组织已经认识到，迫切需要针对热点地区加强艾滋病毒治疗和预防工作。然而，低成本，全面，有效的艾滋病毒控制战略的热点证据是有限的，因此是该领域的优先需要。我们建议在卡森塞罗进行一项家庭随机对照试验，以评估社区卫生工作者在移动的卫生技术（mHealth）支持下推广联合艾滋病毒预防（CHP）服务对艾滋病毒服务吸收和艾滋病毒发病率的影响。联合艾滋病毒预防（CHP）是实施多种艾滋病毒预防服务（艾滋病毒检测和咨询，抗逆转录病毒治疗，医疗男性包皮环切术和行为改变），以最大限度地提高人口水平对艾滋病毒发病率的影响。为了使卫生防护中心能够实质性地降低艾滋病毒的发病率，必须对大多数社区成员进行风险因素和目前卫生防护中心使用情况的评估，然后进行分类、激励、联系，如果感染了艾滋病毒，则继续接受护理。拟议的干预措施将使用低成本的社区卫生工作者，利用移动健康决策支持、咨询和短信工具，沿着这整个服务利用的连续性来促进CHP。干预的可行性已经得到了试点工作的支持，我们现在提出一个随机评估。假设是，家庭居民接受干预将提高卫生防护中心的服务吸收和降低艾滋病毒的发病率相比，控制。在目标1中，将通过一项务实的家庭随机试验（n~1200户，n~1800名参与者）对干预措施进行评估。干预组参与者将由经过培训的CHW访问，以评估和分类家庭风险类别，提供量身定制的CHP健康咨询，联系和依从性支持，并发送有针对性的短信，所有这些都由移动健康决策支持工具支持。概念框架是基于一个信息，动机和行为技能（sIMB）模型。主要结果将是36个月时的卫生防护中心服务覆盖率和艾滋病毒感染率。其他结果将是社区病毒载量，sIMB和实施措施，保留，病毒学抑制和性行为。在目标2中，将对试验进行混合方法评价，以评价实施过程、促进者和障碍，从而为研究结果和未来的项目吸收提供信息。在后续行动期间和之后将进行焦点小组和深入访谈，并与量化数据进行综合。还将对干预成本进行前瞻性衡量，以提供有关方案负担能力的信息。通过这些目标，一种新的，低成本的，可扩展的干预措施，以提高CHP的吸收将在艾滋病毒的“热点”控制艾滋病毒流行的关键进行评估。研究设计确保了与许多利益相关者直接相关的严格证据。

 DESCRIPTION (provided by applicant): Kasensero, Uganda, a fishing community on Lake Victoria, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field. We propose a household-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). Combination HIV Prevention (CHP) is the implementation of multiple HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population- level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV- infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support, counseling, and text messaging tools to promote CHP along this entire continuum of service utilization. Intervention feasibility has been supported by pilot work, and we now propose a randomized evaluation. The hypotheses are that household residents receiving the intervention will have improved CHP service uptake and decreased HIV incidence compared to controls. In Aim 1, the intervention will be evaluated through a pragmatic, household-randomized trial (n~1200 households, n~1800 participants). Intervention arm participants will be visited by CHWs trained to evaluate and triage household into risk categories, provide tailored CHP health counseling, linkage, and adherence support, and send targeted text messages, all supported by a mHealth decision support tool. The conceptual framework is based on a situated Information, Motivation, and Behavioral Skills (sIMB) model. The primary outcomes will be CHP service coverage and HIV incidence at 36 months. Other outcomes will be community viral load, sIMB and implementation measures, retention, virologic suppression, and sexual behaviors. In Aim 2, mixed methods evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will also be prospectively measured to provide information on program affordability. Through these Aims, a novel, low-cost, and scalable intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.