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）有可能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，艾滋病毒相关孕产妇死亡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%的合格妇女完成了这一“PMTCT级联”。如果妇女拒绝艾滋病毒检测，不透露自己的艾滋病毒状况，或因为害怕与男性伴侣的关系会产生负面后果而避免基本保健服务，那么在防止母婴传播的级联过程中就会出现下降。在怀孕期间让夫妻双方参与有可能加强健康决策，增加医疗保健利用率，并最终改善孕产妇，父亲和婴儿的健康。这项研究的目标是开发和试点以家庭为基础的夫妇干预，包括安全的艾滋病毒检测和披露的夫妇，以及信息和咨询的家庭健康在围产期。我们将根据孕妇及其男性伴侣的特殊需要调整现有的循证夫妻艾滋病毒咨询和检测方案，并培训两名非专业卫生工作者（一名女性和一名男性），作为肯尼亚农村地区家访的一部分提供这项服务。在肯尼亚，由于男子很少去产前诊所，因此家庭战略可以在一个安全和方便的空间接触到夫妇，使他们前所未有地获得家庭健康信息、CHCT服务和护理联系。这种基于社区应对和行为改变的相互依赖模式的干预措施，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环境中的初步研究，我们建议收集进一步的形成性数据，然后将我们的研究结果转化为一个可行的干预模型，并从当地利益相关者那里获得投入。然后，我们将进行一项以家庭为基础的夫妇干预的试点研究，在这项研究中，我们将在两个产前诊所将孕妇随机分配到研究的干预或标准护理组，并跟踪他们及其男性伴侣，直到婴儿预产期后三个月。我们将初步评估干预措施对 夫妇接受CHCT，艾滋病毒阴性妇女在怀孕期间重复进行艾滋病毒检测，艾滋病毒阳性妇女和男子利用防止母婴传播和艾滋病毒服务。我们还将探讨潜在的中介者的作用，这些影响所建议的相互依存的概念框架（如夫妇关系的动态措施）。这项研究的结果将提供干预和研究方法的初步影响，可接受性和可行性的证据，这将使我们的团队能够开发更大规模的疗效试验。让怀孕夫妇参与家庭保健和防止母婴传播，是撒哈拉以南非洲降低与艾滋病毒有关的孕产妇死亡率和消除儿童新感染艾滋病毒的重要步骤。

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.