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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

这是对当前受到严重影响的 NIMH R01 研究的行政补充申请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率、艾滋病毒相关孕产妇死亡和艾滋病毒感染率降低至 1% 在撒哈拉以南非洲地区，婴儿死亡率仍然高得令人无法接受，在肯尼亚尤其如此。预防母婴传播（PMTCT）服务的级联出现严重下降。卫生系统导致服务覆盖范围不足，但诊所之外还存在许多障碍——在合作伙伴、我们团队对高艾滋病毒感染者的研究表明，家庭和社区因素会影响女性的健康决策。肯尼亚西南部的流行地区表明，许多妇女避免夫妻进行艾滋病毒检测，并且不进行艾滋病毒检测。坚持预防母婴传播 (PMTCT) 方案，因为他们担心男性伴侣会产生负面后果。对家庭健康发挥着至关重要的支持作用，但肯尼亚的男性伴侣在产前保健方面的参与度很低，怀孕期间夫妇进行艾滋病毒检测的比例较低孕妇希望一起接受艾滋病毒检测。与他们的伴侣，并需要在夫妻艾滋病毒检测和咨询中相互披露的支持（CHTC），无论他们是否知道自己的艾滋病毒状况，在这种情况下，我们正在测试一种方法的功效。基于相互依存理论的夫妻干预，通过以下方式影响孕妇和男性伴侣：由男女非专业卫生工作者进行家访，包括提供家庭 CHTC 服务。正在进行一项强有力的调查，以确定这种干预措施是否可以提高夫妇艾滋病毒的感染率除了该地区正在使用的不太密集的男性参与策略之外，还进行了测试和健康结果。我们正在对 800 名孕妇及其伴侣进行一项三臂试验，将他们随机分配到家里—— 基于夫妇的探访、与男性伴侣一起使用的艾滋病毒自检 (HIVST) 套件或标准护理、跟踪夫妇在目标 1 中，我们正在确定干预措施对我们主要结局的影响。与 HIVST 试剂盒和标准护理相比，对夫妇 HIV 检测进行检查在目标 2 中，我们关注干预影响。感染者夫妇的艾滋病毒预防行为、设施提供和产后保健利用。 HIV 次要结局包括母亲 VL 抑制和无 HIV 儿童存活长达 18 个月。 3，我们正在比较家庭夫妻干预与资源较少的成本效益由于对现场研究的限制，其他两个研究组使用了强化策略。由于 COVID-19 大流行，我们比计划晚了一年多完成了 800 对夫妇的登记，并将无法在最初分配的时间范围内完成样本的干预实施和随访该行政补充对于实现我们的研究目标和提供信息是必要的。决策者关于让怀孕夫妇参与预防母婴传播和家庭健康的具有成本效益的策略，对孕产妇、父亲和婴儿健康具有重要的下游效益。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

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