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

肯尼亚夫妻参与预防母婴传播和家庭健康的策略测试

• 批准号: 10390310
• 负责人: LYNAE A DARBES
• 金额: $ 59.37万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-17 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10390310
• 关键词: AIDS prevention; Adherence; Africa South of the Sahara; Area; Behavior; Child; Child Health; Clinic; Collaborations; Consequences of HIV; Counseling; Country; Couples; Decision Making; Diagnostic Reagent Kits; Disclosure; Drops; Effectiveness of Interventions; Ensure; Exclusive Breastfeeding; Family; Family health status; Female; Fright; Goals; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV diagnosis; Health; Health Services; Health behavior; Health care facility; Health system; Home; Home visitation; Human immunodeficiency virus test; Individual; Infant; Infant Health; Infant Mortality; Intervention; Intervention Studies; Investigation; Kenya; Letters; Maternal Health; Maternal Mortality; Maternal and Child Health; Modeling; Mother-to-child HIV transmission; Outcome; Participant; Pilot Projects; Play; Postpartum Period; Pregnancy; Pregnant Women; Prevalence; Prevention; Public Health; Randomized; Randomized Controlled Trials; Regimen; Reporting; Research; Resource-limited setting; Resources; Risk; Role; Services; Shapes; Source; Test Result; Testing; Vertical Disease Transmission; Visit; Woman; Women' s Health; antenatal; antenatal care; antiretroviral therapy; arm; base; commune; community-level factor; comparative cost effectiveness; condoms; coping; cost effective; cost effectiveness; efficacy evaluation; efficacy testing; family support; health care service utilization; high risk; improved; infant death; innovative technologies; intervention effect; male; maternal outcome; member; men; postnatal; postpartum care; pre-exposure prophylaxis; preference; pregnant; primary outcome; secondary outcome; self testing; social stigma; standard care; standard of care; theories; three-arm trial; transmission process; two-arm study; uptake

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.

尽管有可能进行抗逆转录病毒疗法来改善孕产妇健康并减少母亲 将艾滋病毒传播到低至1％，与艾滋病毒相关的遗产死亡和艾滋病毒感染仍然存在 撒哈拉以南非洲地区的高度高。在肯尼亚尤其如此，在肯尼亚发生关键的下降 在预防母子传播（PMTCT）服务的级联中。较弱的卫生系统 有助于服务覆盖范围不足，但许多障碍在诊所以外 - 在伴侣，家庭和 塑造妇女健康决定的社区因素。我们团队在高艾滋病毒患病率领域的研究 肯尼亚西南部表明，许多女性避免夫妻艾滋病毒测试，并且不遵守PMTCT 方案是因为他们担心男性伴侣的负面后果。男人可以发挥关键的支持 家庭健康的角色，但肯尼亚的男性伴侣参与了天内护理和夫妻的吸收 怀孕期间的艾滋病毒测试很低。孕妇希望与伴侣一起接受艾滋病毒的测试 并需要支持夫妻艾滋病毒测试和咨询（CHTC）的相互披露的支持，不管 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 基于理论的相互依存关系夫妇干预，通过 由外行卫生工作者组成的男女访问，包括基于家庭的CHTC服务的提供。我们的 与96对怀孕夫妇（R34MH102103）进行此干预的随机试验研究表明 夫妻测试的吸收增加（干预措施为64％，对照23％，p <0.001）和显着 健康行为的改善，例如独家母乳喂养和产后护理。我们现在建议 更强大的投资，以确定这种干预是否可以改善夫妻艾滋病毒测试的吸收和 与该地区使用的男性参与策略相比，健康成果超过了不太密集的男性参与策略。我们 提议在1080名孕妇和伴侣中进行三臂试验，然后将其随机为家庭 - 基于夫妇访问，与男性伴侣一起使用的艾滋病毒自我测试（HIVST）套件或标准护理（男性伴侣 诊所邀请函），夫妻在产后长达18个月的夫妻之后。在AIM 1中，我们将确定效果 与HIVST套件和标准护理相比，我们对夫妇HIV测试的主要结果的干预。 在AIM 2中，我们研究了对艾滋病毒预防行为，设施交付和产后的干预影响 医疗保健利用。在患有艾滋病毒的夫妇中，次要结果包括材料VL抑制 和无艾滋病毒的儿童生存长达18个月。在AIM 3中，我们比较基于家庭的成本效益 夫妻干预其他两个研究组中使用的资源密集型策略较少。我们的理论 - 基于夫妻的干预具有增加夫妇艾滋病毒测试和为家庭协作的强大潜力 健康。这项研究将为决策者提供有关具有成本效益的策略，以使怀孕夫妇参与 PMTCT和家庭健康，对母校，父亲和婴儿健康具有重要的下游益处。