Piloting risk stratification and tailored interventions with pregnant and postpartum women with HIV in Kenya to prevent disengagement from care and viral failure

尽管抗逆转录病毒疗法(ART)在孕妇和产后妇女中的覆盖率显著扩大 在全球范围内，艾滋病毒携带者(PWLWH)儿童新感染艾滋病毒的数量已经停滞不前，而且显著减少 普惠制妇女人数仍然不能达到最佳健康结果。在撒哈拉以南非洲，新兴市场 有证据表明，PWLWH的一些脆弱亚群对ART依从性差的风险更高， 脱离艾滋病毒护理，以及不受抑制的病毒载量。为了消除母婴传播 并保护产妇健康，关键是要及早发现这些面临不良结局风险的妇女，并 提供应对关键挑战的有效干预措施。有重要的证据表明，心理社会 压力来源--与艾滋病毒有关的污名、亲密伴侣的暴力行为以及无法披露艾滋病毒状况--是主要的 在这一人群中，治疗的驱动因素出现了失误。Problem Management Plus(PM+)是业外卫生工作者提供的服务 具有解决心理社会应激源和促进治疗参与度的高潜力干预措施 高危PWLWH。PM+结合了问题解决疗法和行为策略来解决精神困扰 并已在肯尼亚的其他人口中得到适应和实施。在目前的研究中，我们建议 开发和验证使用社会人口统计、临床和社会统计数据的多变量预测工具(即“风险计算器 来自我们最近对肯尼亚西南部PWLWH大样本进行的纵向研究的心理社会数据， 与我们目前提出的研究的背景相同(目标1)。我们将建立风险优先级评分(关键、 中度，轻微)，预测错过就诊(&>30天)或治疗失败(升高)的综合结果 病毒载量为400拷贝/毫升)。接下来，我们将利用以人为中心的设计(HCD)方法进行协作 与PWLWH和主要利益相关方一起定制PM+干预的可修改组件，以解决 在这一人群中实现最佳艾滋病毒治疗结果的挑战(目标2)。我们将与 PWLWH和非专业卫生工作者开发移动电话(MHealth)和面对面PM+交付模式，以 能够安全、高效地向流动人口提供干预。最后，我们将试行我们量身定制的 一项混合型2型有效性实施试验的干预，在该试验中，孕妇被确定为危重孕妇 或中等风险被随机分配到三个1：1：1标准护理、面对面PM+或mHealth三个研究组之一 PM+，产后6个月随访(N=120)。可行性、可接受性、干预满意度和 将评估对精神健康和艾滋病毒结果的初步影响。这项研究的发现将为 我们进行了一项大规模试验，我们打算使用适应性设计测试哪些干预措施(包括 调整后的PM+)、干预组合和干预顺序是最有效和高效的 在低资源环境下支持最易受攻击的PWLWH。这项研究将产生有效的工具和 适应性干预模式，将有助于消除母婴传播和实现 相关的全球妇幼保健目标。

Despite the notable scale up of antiretroviral therapy (ART) coverage among pregnant and postpartum women living with HIV (PWLWH) globally, reductions in new HIV infections in children have plateaued and significant numbers of PWLWH are still not able to achieve optimal health outcomes. In sub-Saharan Africa, emerging evidence indicates some vulnerable sub-groups of PWLWH are at higher risk of poor ART adherence, disengagement from HIV care, and unsuppressed viral loads. In order to eliminate mother-to-child transmission and protect maternal health, it is critical to identify these PWLWH at risk of suboptimal outcomes early and provide effective interventions that address key challenges. There is significant evidence that psychosocial stressors—HIV-related stigma, intimate partner violence, and lack of ability to disclose HIV status—are major drivers of treatment lapses in this population. Problem Management Plus (PM+) is a lay health worker-delivered intervention that has high potential to address psychosocial stressors and promote treatment engagement for high risk PWLWH. PM+ combines problem-solving therapy and behavioral strategies to address mental distress and has been adapted and implemented in other populations in Kenya. In the current study, we propose to develop and validate a multivariable prediction tool (i.e., “risk calculator”) using socio-demographic, clinical, and psychosocial data from our recent longitudinal studies with large samples of PWLWH in southwestern Kenya, the same setting where our current study is proposed (Aim 1). We will establish risk prioritization scores (critical, moderate, minor) that predict the combined outcome of a missed visit (> 30 days) or treatment failure (elevated viral load >400 copies/ml). Next, we will utilize a human centered design (HCD) approach to work collaboratively with PWLWH and key stakeholders to tailor modifiable components of the PM+ intervention to address challenges to achieving optimal HIV treatment outcomes in this population (Aim 2). We will collaborate with PWLWH and lay health workers to develop both mobile phone (mHealth) and in-person PM+ delivery formats to be able to deliver the intervention safely and efficiently to a mobile population. Finally, we will pilot our tailored intervention in a hybrid type 2 effectiveness-implementation trial in which pregnant women identified as critical or moderate risk are randomized to one of three study arms 1:1:1 standard of care, in-person PM+, or mHealth PM+ and followed through 6 months postpartum (N=120). Feasibility, acceptability, intervention satisfaction, and preliminary effects on mental health and HIV outcomes will be assessed. Findings from this research will prepare us for a large-scale trial in which we intend to use an adaptive design to test which interventions (including adapted PM+), combination of interventions, and sequence of interventions are the most effective and efficient to support the most vulnerable PWLWH in low-resource settings. This research will result in effective tools and adaptive intervention modalities which will contribute to eliminating mother-to-child transmission and achieving related global maternal and child health goals.