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孕产妇健康，减少母婴传播， 艾滋病毒传播率低至1%，与艾滋病毒有关的孕产妇死亡和婴儿感染艾滋病毒的情况仍然存在， 在撒哈拉以南的非洲地区，这一数字高得令人无法接受。在肯尼亚尤其如此， 在预防母婴传播服务的级联中。卫生系统薄弱 导致服务覆盖面不足，但许多障碍超出了诊所-在合作伙伴，家庭， 影响妇女健康决策的社区因素。我们的团队在艾滋病高发地区的研究 肯尼亚西南部的一项研究表明，许多妇女避免进行夫妇艾滋病毒检测，也不坚持预防母婴传播， 因为他们害怕男性伴侣的负面影响。男人可以起到关键的支持作用 家庭健康的作用，但在肯尼亚的男性伴侣很少参与产前护理和夫妇的吸收 怀孕期间的艾滋病毒检测率很低。孕妇希望与其伴侣一起接受艾滋病毒检测 并需要支持参与夫妇艾滋病毒检测和咨询（CHTC）的相互披露， 他们是否知道自己的艾滋病状况。在这种情况下，我们建议测试一种 以相互依存理论为基础的夫妇干预措施，通过以下方式接触孕妇和男性伴侣： 由非专业卫生工作者男女配对进行家访，包括提供家庭卫生和保健中心服务。我们 对96对怀孕夫妇进行的这项干预的随机初步研究（R34 MH 102103）显示， 夫妇测试的接受率增加（干预组为64%，对照组为23%，p<0.001）， 改善健康行为，如纯母乳喂养和产后护理。我们现在提出一个 更有力的调查，以确定这种干预措施是否提高了夫妇艾滋病毒检测的接受率， 在该区域采用的男性参与程度较低的战略之外，还需要取得更多的健康成果。我们 建议在1080名孕妇和伴侣中进行一项三臂试验，将他们随机分配到家中- 基于夫妇的访问，艾滋病毒自我检测（HIVST）试剂盒与他们的男性伴侣使用，或标准护理（男性伴侣 诊所邀请函），跟踪夫妇产后18个月。在目标1中，我们将确定 与艾滋病病毒检测试剂盒和标准护理相比，我们对夫妇艾滋病病毒检测的主要结果进行干预。 在目标2中，我们研究了干预对艾滋病毒预防行为、设施分娩和产后的影响。 保健利用。在感染艾滋病毒的夫妇中，次要结局包括母亲VL抑制 以及无艾滋病毒儿童存活长达18个月。在目标3中，我们比较了基于家庭的 将干预与其他两个研究组中使用的资源密集度较低的策略相结合。我们的理论是- 基于夫妇的干预措施具有很大的潜力，可以增加夫妇艾滋病毒检测和家庭合作 健康这项研究将为决策者提供有关使怀孕夫妇参与的具有成本效益的战略的信息， 预防母婴传播和家庭健康，对孕产妇、父亲和婴儿健康具有重要的下游效益。

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.