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

在肯尼亚对感染艾滋病毒的孕妇和产后妇女进行风险分层和量身定制的干预措施试点，以防止脱离护理和病毒失败

• 批准号: 10408229
• 负责人: Lisa Lynn Abuogi
• 金额: $ 23.97万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-09 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10408229
• 关键词: Address; Adherence; Africa South of the Sahara; Behavioral; Car Phone; Caring; Child; Clinic Visits; Clinical; Cluster randomized trial; Communities; Complex; Data; Distress; Dropout; Ensure; Evidence based intervention; Face; Failure; Family; Funding; Goals; HIV; HIV Infections; Health; Hybrids; Infant; Intervention; Kenya; Longitudinal Studies; Maternal Health; Maternal and Child Health; Mental Depression; Mental Health; Mentors; Methods; Minor; Modality; Mother-to-child HIV transmission; Mothers; Newly Diagnosed; Outcome; Performance; Persons; Population; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Psyche structure; Psychosocial Assessment and Care; Psychosocial Factor; Randomized; Research; Resource-limited setting; Resources; Risk; Risk Factors; Sampling; Specialist; Subgroup; Testing; Text Messaging; Treatment Failure; Treatment outcome; Vertical Disease Transmission; Violence; Viral; Viral Load result; Visit; Woman; Work; adaptive intervention; antiretroviral therapy; base; design; effective intervention; effectiveness implementation trial; experience; follow-up; health goals; high risk; human centered design; improved; intimate partner violence; mHealth; male; novel; pilot test; pregnant; prevent; primary outcome; problem solving therapy; programs; psychosocial; psychosocial stressors; risk stratification; satisfaction; scale up; social stigma; sociodemographics; standard of care; therapy adherence; three-arm study; tool; visit adherence

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.

尽管抗逆转录病毒治疗（ART）在孕妇和产后妇女中的覆盖率显着扩大 全球艾滋病毒感染者 (PWLWH) 儿童新发艾滋病毒感染人数的减少已趋于稳定且显着 在撒哈拉以南非洲地区，仍有许多艾滋病毒/艾滋病患者无法获得最佳健康结果。 有证据表明，一些弱势群体的艾滋病治疗依从性较差， 脱离艾滋病毒护理和不受抑制的病毒载量，以消除母婴传播。 并保护孕产妇健康，尽早识别这些处于次优结果风险的 PWLWH 至关重要 提供应对关键挑战的有效干预措施 有重要证据表明心理社会。 压力源——与艾滋病毒相关的耻辱、亲密伴侣暴力以及缺乏披露艾滋病毒状况的能力——是主要的 问题管理升级版 (PM+) 是由非专业卫生工作者提供的。 干预措施很有可能解决心理社会压力因素并促进治疗参与 高风险 PWLWH。PM+ 结合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群中进行了调整和实施。在当前的研究中，我们建议： 使用社会人口统计、临床和数据开发和验证多变量预测工具（即“风险计算器”） 我们最近对肯尼亚西南部的 PWLWH 大样本进行的纵向研究的心理社会数据， 我们将建立风险优先级评分（关键， 中度、轻微），可预测错过就诊（> 30 天）或治疗失败（升高）的综合结果 病毒载量 >400 拷贝/毫升）接下来，我们将利用以人为本的设计（HCD）方法进行协作。 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所面临的挑战（目标 2）。 PWLWH 和非专业卫生工作者开发手机 (mHealth) 和面对面 PM+ 交付格式，以 最后，我们将试点我们量身定制的干预措施。 对 2 型混合有效性实施试验进行干预，其中孕妇被认为是关键 或中等风险被随机分配到三个研究组之一：1:1:1 标准护理、面对面 PM+ 或 mHealth PM+ 并跟踪产后 6 个月（N=120）。 将评估对心理健康和艾滋病毒结果的初步影响。 我们进行了一项大规模试验，我们打算使用适应性设计来测试哪些干预措施（包括 适应的 PM+）、干预组合和干预顺序是最有效和高效的 为资源匮乏地区最脆弱的低龄老人提供支持 这项研究将产生有效的工具和方法。 适应性干预方式将有助于消除母婴传播并实现 相关的全球孕产妇和儿童健康目标。