Research, Care and Treatment Programme, Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.
Trials. 2021 Jan 6;22(1):19. doi: 10.1186/s13063-020-04956-1.
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.
尽管撒哈拉以南非洲地区的产前保健服务有所增加，并向孕妇提供了抗逆转录病毒疗法，但艾滋病毒相关的孕产妇死亡和婴儿艾滋病毒感染仍然居高不下。在 Jamii Bora（斯瓦希里语中意为“更好的家庭”）研究中，我们试图测试基于相互依存理论的夫妇干预的效果。该干预措施通过男女 lays 卫生工作者的家访来接触孕妇及其男性伴侣。目的是增加家庭内夫妇艾滋病毒检测和咨询服务的获取途径，以改善家庭健康。
这是在肯尼亚基苏木和米戈利县进行的一项针对 1080 名 15 岁及以上、与男性伴侣生活在一起且尚未接受夫妇艾滋病毒检测和咨询的孕妇的三臂随机对照试验。夫妇将被随机分为三组：家庭内夫妇访问、供夫妇使用的艾滋病毒自我检测包或标准护理（男性伴侣诊所邀请信）。参与者将在产后 18 个月内进行随访。该研究有三个目标：在目标 1 中，我们将确定与艾滋病毒自我检测包和标准护理相比，干预措施对我们的主要结局——夫妇艾滋病毒检测的影响；在目标 2 中，我们将研究干预措施对艾滋病毒预防行为、医疗机构分娩和产后保健利用的影响，以及次要健康结果，即艾滋病毒阳性夫妇的母婴病毒抑制和 18 个月内无艾滋病毒的儿童存活情况；在目标 3 中，我们将比较基于家庭的夫妇干预与其他两个研究臂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、妊娠晚期以及产后 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策略的信息，这些策略可以使怀孕夫妇参与预防母婴传播和家庭健康，这对母婴、父婴和婴儿健康都有重要的下游效益。
ClinicalTrials.gov NCT03547739。注册于 2018 年 5 月 9 日。
