A Home-Based Couples Intervention to Enhance PMTCT and Family Health in Kenya

描述（由申请人提供）：尽管抗逆转录病毒疗法（ART）有潜力确保孕产妇健康并将艾滋病毒垂直传播降低至1%，但在撒哈拉以南非洲，与艾滋病毒相关的孕产妇死亡率和婴儿艾滋病毒感染率仍然高得令人无法接受。预防母婴传播（PMTCT）需要在整个怀孕期间和出生后采取一系列复杂的干预措施，估计只有15-30%的符合条件的妇女完成了这一“预防母婴传播级联”。如果妇女拒绝艾滋病毒检测，不透露其艾滋病毒状况，或因为担心对其与男性伴侣的关系产生负面影响而逃避基本保健服务，则可能出现预防母婴传播级联的下降。在怀孕期间让夫妻双方都参与有可能加强健康决策，增加医疗保健的利用，并最终改善母亲、父亲和婴儿的健康。这项研究的目的是开发和试点一种以家庭为基础的夫妇干预措施，其中包括对夫妇进行安全的艾滋病毒检测和披露，以及在围产期为家庭健康提供信息和咨询。我们将调整现有的基于证据的夫妻艾滋病毒咨询和检测（CHCT）方案，以满足孕妇及其男性伴侣的特殊需求，并培训对非专业卫生工作者（一男一女），将这项服务作为肯尼亚农村家访的一部分提供。在肯尼亚，由于男性很少去产前诊所，因此以家庭为基础的策略可以在一个安全和方便的空间内接触到这对夫妇，并使他们能够前所未有地获得家庭健康信息、CHCT服务和与护理的联系。这一干预措施基于共同应对和行为改变的相互依存模式，预计将帮助夫妇就艾滋病毒和家庭健康进行沟通、计划和采取行动。基于我们团队在肯尼亚农村地区的初步研究，我们建议收集进一步的形成性数据，然后将我们的发现转化为可行的干预模型，并得到当地利益相关者的投入。然后，我们将进行一项以家庭为基础的夫妻干预的试点研究，在这项研究中，我们将随机将两家产前诊所的孕妇分为干预组或标准护理组，并跟踪她们和她们的男性伴侣，直到婴儿预产期后三个月。我们将对干预的效果进行初步评估

DESCRIPTION (provided by applicant): Despite the potential for anti-retroviral therapy (ART) to ensure maternal health and reduce vertical HIV transmission to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. Prevention of mother-to-child transmission (PMTCT) requires a complex series of interventions throughout pregnancy and after birth, and only an estimated 15-30% of eligible women complete this "PMTCT cascade". Drop-offs can occur in the PMTCT cascade if women refuse HIV testing, do not disclose their HIV status, or avoid essential health services because they fear negative consequences for their relationship with their male partner. Engaging both partners of a couple during pregnancy has the potential to enhance health decisions, increase healthcare utilization, and ultimately improve maternal, paternal, and infant health. The goal of this study is to develop and pilot a home-based couples intervention that includes safe HIV testing and disclosure for couples, alongside information and counseling for family health during the perinatal period. We will adapt existing evidence-based Couples HIV Counseling and Testing (CHCT) protocols for the special needs of pregnant women and their male partners, and train pairs of lay health workers (one female and one male) to deliver this service as part of home visits in rural Kenya. As men rarely attend antenatal clinics in Kenya, a home-based strategy can reach the couple in a safe and convenient space and give them unprecedented access to family health information, CHCT services, and linkage to care. This intervention, based on an interdependence model of communal coping and behavior change, is expected to help couples to communicate, plan, and take action around HIV and family health. Building on our team's preliminary studies in this rural Kenyan setting, we propose to collect further formative data and then translate our findings into a viable intervention model with input from local stakeholders. We will then conduct a pilot study of the home-based couples intervention, in which we will randomize pregnant women at two antenatal clinics to the intervention or standard care arms of the study, and follow them and their male partners until three months after the expected delivery date of the baby. We will preliminarily assess the effects of the intervention on uptake of CHCT by couples, repeat HIV testing during pregnancy for HIV- negative women, and utilization of PMTCT and HIV services for HIV-positive women and men. We will also explore the roles of potential mediators for these effects suggested by our interdependence conceptual framework (such as measures of couple relationship dynamics). Results from this study will provide evidence of the preliminary impact, acceptability, and feasibility of the intervention and the study methods, that will allow our team to develop a larger-scale efficacy trial. Engaging pregnant couples in family health and PMTCT is an essential step towards reducing HIV-related maternal mortality and eliminating new HIV infections among children in sub-Saharan Africa.