Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya

尽管抗逆转录病毒疗法有可能改善产妇健康和减少母婴传播 艾滋病毒传播率低至1%，与艾滋病毒相关的孕产妇死亡和婴儿感染艾滋病毒的情况依然存在 整个撒哈拉以南非洲地区的死亡率高得令人无法接受。这在肯尼亚尤其如此，那里出现了关键的下降 在预防母婴传播(母婴传播)服务的级联中。薄弱的卫生系统 导致服务覆盖范围不足，但许多障碍存在于诊所之外-在合作伙伴、家庭和 影响妇女健康决策的社区因素。我们团队在艾滋病高发区的研究 肯尼亚西南部的研究表明，许多妇女避免对夫妇进行艾滋病毒检测，也不坚持母婴传播。 养生是因为她们害怕男性伴侣带来的负面后果。男人可以起到至关重要的支持作用 对家庭健康的作用，但肯尼亚的男性伴侣在产前护理和夫妇接纳方面参与度较低 怀孕期间的艾滋病毒检测很低。孕妇希望与伴侣一起接受艾滋病毒检测 并需要支持夫妻艾滋病毒检测和咨询(CHTC)中涉及的相互披露 他们是否知道自己的艾滋病毒状况。在这种情况下，我们建议测试一种 基于相互依赖理论的夫妇干预，通过以下途径接触到孕妇和男性伴侣 男女成对的业外卫生工作者的家访，包括提供以家庭为基础的CHTC服务。我们的 对96对怀孕夫妇(R34MH102103)进行的这项干预的随机试点研究表明， 夫妇测试的接受率增加(干预组%，对照组23%，p&lt；0.001)，且显著 改善纯母乳喂养和产后护理等健康行为。我们现在提出一项 更有力的调查，以确定这一干预措施是否改善了夫妇艾滋病毒检测和 健康结果超过该区域正在使用的不那么密集的男性参与战略。我们 建议在1080名孕妇和伴侣中进行一项三臂试验，随机将她们送回家- 基于夫妇探视、艾滋病毒自检(HIVST)试剂盒与其男性伴侣一起使用，或标准护理(男性伴侣 诊所邀请函)，对产后18个月的夫妇进行跟踪。在目标1中，我们将确定影响 与HIVST试剂盒和标准护理相比，干预对夫妇艾滋病毒检测的主要结果的影响。 在目标2中，我们检查了干预对艾滋病毒预防行为、设施交付和出生后的影响 医疗保健利用率。在感染艾滋病毒的夫妇中，次要结果包括母亲VL抑制 和无艾滋病毒儿童存活长达18个月。在目标3中，我们比较了以家庭为基础的 夫妇对其他两个研究小组使用的资源密集型策略进行干预。我们的理论是- 以夫妇为基础的干预措施在增加夫妇艾滋病毒检测和家庭合作方面具有很大潜力 健康。这项研究将为决策者提供关于让怀孕夫妇参与到 防止母婴传播和家庭健康，对母亲、父亲和婴儿健康具有重要的下游好处。

Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic—in the partner, family, and community factors that shape women's health decisions. Our team's research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, we propose to test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. Our randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. We now propose a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. We propose to conduct a three-arm trial among 1080 pregnant women and partners, randomizing them to home- based couple visits, HIV self-test (HIVST) kits to use with their male partner, or standard care (male partner clinic invitation letters), following couples up to 18 months postpartum. In Aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIVST kits and standard care. In Aim 2, we examine intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization. Among couples living with HIV, secondary outcomes include maternal VL suppression and HIV-free child survival up to 18 months. In Aim 3, we compare the cost-effectiveness of the home-based couples intervention to the less resource-intensive strategies used in the other two study arms. Our theory- based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. This study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.