Intervention for Sustained Testing and Retention (iSTAR) Among HIV-infected Patients

 描述（由申请人提供）：在全球范围内，尼日利亚拥有第二大数量：a）艾滋病毒感染者，B）新的艾滋病毒感染者，c）感染艾滋病毒的孕妇。2013年，只有17.1%的15-49岁育龄妇女接受了艾滋病毒检测在尼日利亚估计有190 000名感染艾滋病毒的孕妇中，只有27%的孕妇接受了预防母婴传播艾滋病毒的抗逆转录病毒治疗，相比之下，撒哈拉以南非洲（SSA）接受抗逆转录病毒治疗的孕妇占68%。在21个重点国家中，尼日利亚占儿童艾滋病毒新感染的25%（估计有51 000例新感染）。在撒南非洲，大约49%的艾滋病毒感染孕妇在产前保健登记和分娩之间失去了后续行动，45%的婴儿在艾滋病毒检测后丢失。在尼日利亚，感染艾滋病毒的妇女和儿童中，失访率很高（15%-56%）。2014年，我们证明了健康开端倡议（HBI），一个由教会卫生团队提供的以教会为基础的干预措施，与以诊所为基础的方法相比，在增加孕妇艾滋病毒检测方面更有效。HBI利用教会组织的婴儿淋浴来参与和识别怀孕早期的妇女，将教育干预与综合的现场实验室测试相结合，旨在减少与艾滋病毒检测相关的耻辱感。婴儿接收便利了分娩后的后续行动和与护理的联系。HBI解决了艾滋病毒检测的几个障碍：感染风险低的观念（教育），获得检测和治疗的机会，以及费用和耻辱（现场，免费，综合检测）。每个社区至少有一个信仰机构，这为评估iSTAR的有效性提供了一个独特的机会，iSTAR是一种基于社区和诊所的综合干预措施，旨在检测、联系、吸引和维持接受护理的艾滋病毒感染妇女。我们提出了一个集群随机比较有效性试验的iSTAR与临床为基础的方法（CG）。我们将评估400名感染艾滋病毒的妇女之间的联系、参与、保留和病毒抑制。基于EPIS框架，我们将使用社会网络干预方法来促进实施，并评估实施领导和背景。尼日利亚南部的50个教会将被随机分配（1：1）到iSTAR或CG。iSTAR干预措施提供：在婴儿洗礼期间进行保密的现场综合实验室检测;教会保健顾问网络;接受过动机访谈培训的诊所小组;提高质量技能，以吸引和支持感染艾滋病毒的妇女;以及综合病例管理，以减少后续行动的损失。主要结局是iSTAR和CG之间的联系和参与率差异。次要结局是保留率和病毒抑制率的差异。该提案是以下机构合作提出的：尼日利亚大学（总统艾滋病紧急救援计划资助的尼日利亚合作伙伴[培训和地方项目监督]）、南加州大学（网络分析）、加州大学圣地亚哥分校（实施科学）、国际学院芝加哥分校（可持续性评估）、内华达州州立学院（统计分析和调解/适度分析）以及内华达州、拉斯维加斯大学（全面监督方案实施和评价）。

 DESCRIPTION (provided by applicant): Globally, Nigeria has the 2nd largest number of: a) people living with HIV, b) new HIV infections, and c) pregnant women living with HIV. In 2013 only 17.1% of women of childbearing age 15-49 years received an HIV test (preceding 12-months) and only 27% of the estimated 190,000 HIV-infected pregnant women in Nigeria who delivered babies received antiretroviral therapy for prevention of mother-to-child HIV transmission (PMTCT), compared to 68% of pregnant women receiving ART overall in sub-Saharan Africa (SSA). Nigeria accounts for 25% of new childhood HIV infections among the 21 priority countries (estimated 51,000 new infections). Roughly 49% of HIV-infected pregnant women in SSA are lost to follow up between registration in antenatal care and delivery, and 45% of infants are lost after HIV testing. Nigeria has high loss to follow-up (15%-56%) among HIV-infected women and children. In 2014, we demonstrated that the Healthy Beginning Initiative (HBI), a congregation-based intervention delivered by church-based health teams, was more effective in increasing HIV testing among pregnant women compared to a clinic-based approach. HBI uses church organized baby showers to engage and identify women early in pregnancy, combines educational intervention with integrated, on-site laboratory testing designed to reduce stigma associated with HIV-only testing. Baby receptions facilitate post-delivery follow-up and linkage to care. HBI addresses several barriers to HIV testing: perception of low risk to infection (education), access to testing and treatment, and cost and stigma (on-site, free, integrated testing). At least one faith-based institution is in each community, presenting a unique opportunity to evaluate the effectiveness of iSTAR, an integrated community and clinic based intervention that is designed to test, link, engage and sustain HIV-infected women in care. We propose a cluster randomized comparative effectiveness trial of iSTAR versus a clinic-based approach (CG). We will assess linkage, engagement, retention and viral suppression among 400 HIV-infected women. Based on the EPIS framework, we will use social network intervention methods to facilitate implementation and also assess implementation leadership and context. Fifty churches in south-south Nigeria will be randomly assigned (1:1) to iSTAR or CG. The iSTAR intervention provides: confidential, onsite integrated laboratory testing during baby showers; a network of church-based health advisors; clinic based teams trained in motivational interviewing; quality improvement skills to engage and support HIV-infected women; and integrated case management to reduce loss to follow-up. Primary outcomes are difference in linkage and engagement rates between iSTAR and CG. Secondary outcomes are difference in retention and viral suppression rate. This proposal is a collaboration among University of Nigeria (PEPFAR-funded partner in Nigeria [training and local project oversight]; University of Southern California (network analysis); UC San Diego (implementation science); UIC Chicago (assessment of sustainment); Nevada State College (statistical analyses and mediation/moderation analysis), and University of Nevada, Las Vegas (overall oversight of program implementation and evaluation).