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.

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.
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DOI:
10.1186/s13063-020-04956-1
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发表时间:
2021-01-06
期刊:
影响因子:
2.5
通讯作者:
Turan JM
Turan JM
中科院分区:
医学4区
文献类型:
--
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

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在撒哈拉以南非洲地区,尽管产前保健就诊人数有所增加,并向孕妇提供抗逆转录病毒治疗,但与艾滋病毒相关的孕产妇死亡和婴儿艾滋病毒感染率仍然高得令人无法接受。在 Jamii Bora(斯瓦希里语“更好的家庭”)研究中,我们试图测试基于相互依赖理论的夫妻干预的有效性。通过男女非专业卫生工作者的家访,干预措施惠及孕妇和男性伴侣。目的是增加家庭夫妇获得艾滋病毒检测和咨询服务的机会,以改善家庭健康。这是一项三组随机对照试验,受试者为肯尼亚基苏木县和米戈里县的 1080 名 15 岁或以上、与男性伴侣同居且未接受过夫妻 HIV 检测和咨询的孕妇。夫妇将被随机分为三组:家庭夫妇探访、供夫妇使用的艾滋病毒自检套件或标准护理(男性伴侣诊所邀请函)。参与者将被跟踪至产后 18 个月。该研究有三个目标:在目标 1 中,我们将与艾滋病毒自我检测试剂盒和标准护理相比,确定干预措施对夫妇艾滋病毒检测主要结果的影响;在目标 2 中,我们将研究干预措施对艾滋病毒预防行为、设施提供和产后保健利用的影响,以及感染艾滋病毒的夫妇的孕产妇病毒抑制和无艾滋病毒儿童存活长达 18 个月的二级健康结果;在目标 3 中,我们将比较家庭夫妇干预措施与其他两个研究组中使用的资源密集度较低的策略的成本效益。对夫妇的评估在基线、怀孕后期以及出生后第 3、6、12 和 18 个月进行。这项研究的结果将为决策者提供有关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的信息,从而为孕产妇、父亲和婴儿的健康带来重要的下游效益。 ClinicalTrials.gov NCT03547739。注册于 2018 年 5 月 9 日 在线版本包含可在 10.1186/s13063-020-04956-1 获取的补充材料。
HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. ClinicalTrials.gov NCT03547739. Registered on May 9, 2018 The online version contains supplementary material available at 10.1186/s13063-020-04956-1.
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