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: 10754429
• 负责人: LYNAE A DARBES
• 金额: $ 15万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10754429
• 关键词: AIDS prevention; Adherence; Administrative Supplement; Africa South of the Sahara; Area; Behavior; COVID-19 pandemic; COVID-19 pandemic effects; Child; Child Health; Clinic; Consequences of HIV; Counseling; Country; Couples; Decision Making; Diagnostic Reagent Kits; Disclosure; Drops; Effectiveness of Interventions; Enrollment; Ensure; Exclusive Breastfeeding; Family; Family health status; Female; Fright; Funding; Goals; Grant; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV diagnosis; Health; Health Benefit; Health behavior; Health system; Home; Home visitation; Human immunodeficiency virus test; Individual; Infant; Infant Health; Infant Mortality; Intervention; Investigation; Kenya; Letters; Maternal Health; Maternal Mortality; Maternal and Child Health; Modeling; Mother-to-child HIV transmission; National Institute of Mental Health; Outcome; Parents; Participant; Persons; 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; Sampling; Services; Shapes; Source; Test Result; Testing; Time; Vertical Disease Transmission; Visit; Woman; Women' s Health; acceptability and feasibility; antenatal; antenatal care; antiretroviral therapy; arm; commune; community-level factor; comparative cost effectiveness; condoms; coping; cost; cost effective; cost effectiveness; efficacy evaluation; efficacy testing; experience; family support; follow up assessment; follow-up; health care service utilization; health service use; high risk; improved; infant death; intervention delivery; 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

This is an application for an administrative supplement to a current NIMH R01 study that was severely affected by the COVID-19 pandemic. 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 are testing 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. We are conducting a 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 are conducting a three-arm trial among 800 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, following couples up to 18 months postpartum. In Aim 1, we are determining the effects of the intervention on our primary outcome of couple HIV testing, compared to HIVST kits and standard care. In Aim 2, we are examining 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 are comparing the cost-effectiveness of the home-based couples intervention to the less resource- intensive strategies used in the other two study arms. Due to restrictions on in-person research posed by the COVID-19 pandemic we completed enrollment of 800 couples more than one year later than planned, and will not be able to complete intervention delivery and follow-up of the sample with the originally allocated time frame and funds. This administrative supplement is necessary to be able to achieve the aims of our study and 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.

这是对目前一项受到严重影响的NIMH R01研究的行政补充申请 受新冠肺炎大流行的影响。尽管抗逆转录病毒疗法有可能改善孕产妇健康和 将艾滋病毒母婴传播降低到1%，减少与艾滋病毒相关的孕产妇死亡和艾滋病毒感染 撒哈拉以南非洲的婴儿死亡率仍然高得令人无法接受。这在肯尼亚尤其如此，在那里 在预防母婴传播(母婴传播)服务的级联中出现了关键的下降。瘦弱 卫生系统导致服务覆盖不足，但许多障碍超出了诊所--在合作伙伴中， 影响妇女健康决策的家庭、社区因素。我们团队对一种高HIV病毒的研究 肯尼亚西南部流行地区显示，许多女性避免对夫妇进行艾滋病毒检测，而不是 坚持预防母婴传播方案，因为他们害怕男性伴侣的负面后果。男人可以扮演一个 对家庭健康起着至关重要的支持作用，但肯尼亚的男性伴侣在产前护理和 夫妇在怀孕期间接受艾滋病毒检测的比例很低。孕妇希望一起接受艾滋病毒检测 与他们的伴侣一起，并需要相互披露的支持，参与夫妻艾滋病毒检测和咨询 (CHTC)，无论他们是否知道自己的艾滋病毒状况。在这种情况下，我们正在测试一种 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 正在进行一项强有力的调查，以确定这种干预是否能改善夫妇感染艾滋病毒的情况 测试和健康结果，而不是该区域正在使用的不那么密集的男性参与战略。 我们正在800名孕妇和伴侣中进行一项三臂试验，随机将她们送回家- 根据夫妇探视、艾滋病毒自我检测(HIVST)试剂盒与其男性伴侣一起使用，或对夫妇进行标准护理 产后长达18个月。在目标1中，我们正在确定干预对我们主要结果的影响 与HIVST试剂盒和标准护理相比，夫妇艾滋病毒检测的比例更高。在目标2中，我们正在研究干预的影响 关于艾滋病毒预防行为、设施交付和产后保健利用。在同住在一起的夫妇中 在艾滋病毒方面，次要结果包括产妇VL抑制和未感染艾滋病毒的儿童存活长达18个月。在AIM 3，我们正在比较居家夫妇干预的成本效益与资源较少的情况- 在其他两个学习组中使用了密集的策略。由于对面对面研究的限制 新冠肺炎大流行我们比原计划推迟了一年多完成了800对新人的招募，并将 不能在最初分配的时间范围内完成样本的干预交付和跟踪 和资金。这一行政补充是必要的，以便能够实现我们的研究和通知的目的 决策者关于让怀孕夫妇参与预防母婴传播和家庭健康的成本效益战略， 对母亲、父亲和婴儿健康的重要下游好处。

项目成果

Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial.

• DOI: 10.1186/s13063-020-04956-1
• 发表时间: 2021-01-06
• 期刊: Trials
• 影响因子: 2.5
• 作者: Kwena Z;Kimbo L;Darbes LA;Hatcher AM;Helova A;Owino G;Thirumurthy H;Bukusi EA;Braun T;Kilgore M;Pisu M;Tamhane A;Nghiem VT;Agot K;Neilands TB;Turan JM
• 通讯作者: Turan JM