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在孕妇和产后妇女中的覆盖率显著提高， 全球艾滋病毒感染者（PWLWH），儿童新发艾滋病毒感染的减少已经趋于稳定， 许多PWLWH仍然无法实现最佳健康结果。在撒哈拉以南非洲， 有证据表明，PWLWH中的一些弱势亚组有较高的抗逆转录病毒疗法依从性差的风险， 脱离艾滋病护理和未受抑制的病毒载量。为了消除母婴传播 和保护孕产妇健康，至关重要的是要及早识别这些处于次优结局风险中的PWLWH， 提供有效的干预措施，应对关键挑战。有大量证据表明， 压力源--与艾滋病毒有关的耻辱、亲密伴侣的暴力和缺乏披露艾滋病毒状况的能力--是主要的 这一人群中治疗失误的驱动因素。问题管理+（PM+）是一个由非专业健康工作者提供的 干预措施，有很大的潜力，以解决心理社会压力，并促进治疗参与， 高风险PWLWH。PM+结合解决问题的治疗和行为策略，以解决精神困扰 并在肯尼亚的其他人群中进行了调整和实施。在目前的研究中，我们建议 开发并验证多变量预测工具（即，"风险计算器"）使用社会人口统计学、临床和 从我们最近对肯尼亚西南部PWLWH的大样本进行的纵向研究中获得的社会心理数据， 与我们目前研究的目的相同（目标1）。我们将建立风险优先级评分（关键， 中度、轻度），可预测错过访视（> 30天）或治疗失败（升高）的联合结局 病毒载量> 400拷贝/ml）。接下来，我们将利用以人为本的设计（HCD）方法来协同工作 与PWLWH和主要利益相关者一起定制PM+干预措施的可修改部分，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的电话（mHealth）和亲自PM+交付格式， 能够安全有效地向移动的人群提供干预。最后，我们将试点我们量身定制的 干预混合2型有效性-实施试验，其中孕妇被确定为关键 或中度风险被随机分配到三个研究组之一，1：1：1标准护理，亲自PM+或mHealth PM+，并随访至产后6个月（N = 120）。可行性、可接受性、干预满意度，以及 将评估对心理健康和艾滋病毒结果的初步影响。这项研究的结果将为 我们进行了一项大规模试验，我们打算使用自适应设计来测试哪些干预措施（包括 适应PM+），干预措施的组合，以及干预措施的顺序是最有效和高效的 在资源匮乏的环境中支持最脆弱的PWLWH。这项研究将产生有效的工具， 有助于消除母婴传播和实现 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.