Partners-based HIV Treatment for Sero-concordant Couples attending Antenatal Care

项目摘要：在资源严重有限的农村地区，扩大服务以消除母婴接触 艾滋病毒传播(EMTCT)未能提供有效的艾滋病毒检测和抗逆转录病毒治疗(ART) 覆盖南部非洲流行率最高地区的妇女。所有感染艾滋病毒的孕妇现在都是 有资格接受终身抗逆转录病毒治疗(ART)，无论CD4+细胞数量(选项B+)，但在 通过选项B+计划注册的女性仍然处于次优状态。在撒哈拉以南非洲(SSA)，这种情况很常见 妇女需要获得男性伴侣的批准才能获得和继续从事与艾滋病毒有关的保健服务。 尽管男性的参与可能会提高项目的覆盖率和忠诚度，但有证据表明 通过ANC护理点让男性伴侣参与艾滋病毒检测和治疗的有效干预基础 是非常有限的。此外，这种战略对于改善艾滋病毒的结果是否确实具有成本效益-- 妊娠期的诊断和治疗尚不清楚。我们的建议旨在解决这些关键差距， 通过评估有前景的男性参与干预措施的证据基础和指导扩大规模(“Homens第 Saúde“(啤酒花)+[促进健康的男人])通过临床随机试验在莫桑比克瞄准EMTCT。我们会 使用24个非国大诊所；12个干预措施和12个标准护理，每个诊所有40对艾滋病毒感染夫妇 目前，60%的夫妇一起参加了他们的第一次非国大访问。计划中的干预针对的是社会- 结构和文化因素通过创建以夫妇为中心的综合艾滋病毒来影响紧急母婴传播 服务，包括：(1)基于ANC的夫妇艾滋病毒检测、抗逆转录病毒治疗登记和血清一致艾滋病毒+的护理 孕期夫妇；(2)产后夫妇治疗；(3)夫妇教育和 技能培养；以及(4)在夫妻专家-患者(同伴)支持者的支持下，治疗的连续性 他们已经成功地通过了紧急救援计划。鉴于8.0%的孕妇和7.2%的伴侣 2015年非国大就诊期间艾滋病毒检测呈阳性(FGH监测和评估[M&E]数据)，我们的开创性 在莫桑比克农村赞比西亚省的研究表明，创新战略对于 让感染艾滋病毒的男性伴侣参与产前护理，以实现母婴传播和改善 这对母亲的健康有很大的影响。我们的莫桑比克和美国调查团队有一个被证明的记录 国际艾滋病毒研究取得成功，我们最近有随机进行EMTCT分组的具体经验 试验，男性参与非国大服务，以及艾滋病毒项目的成本效益分析。具体目标 这项研究的主要内容是：(1)实施和评估男性参与、以夫妇为中心的服务对 HIV+孕妇及其HIV+孕妇的护理保持、对抗逆转录病毒疗法的坚持和婴儿早期诊断 男性伴侣通过随机整群随机对照试验；(2)考察啤酒花+对假设的影响 变化机制；以及(3)使用经过验证的模拟模型来评估 使用规划的省级监测和评估数据和我们试验结果的数据进行HOPS+干预。

Project Summary: In severely resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV (EMTCT) has failed to provide effective HIV testing and antiretroviral therapy (ART) coverage for women in highest prevalence southern African regions. All HIV-infected pregnant women are now eligible for life-long antiretroviral therapy (ART), regardless of CD4+ cell count (Option B+) but retention among women enrolled through Option B+ programs remains sub-optimal. In sub-Saharan Africa (SSA) it is common for women to require male partner approval to access and remain engaged in HIV-related health services. Despite the likelihood that male involvement would improve program coverage and adherence, the evidence base for effective interventions to involve male partners in HIV testing and treatment through ANC point of care is very limited. Furthermore, whether such strategies are indeed cost-effective for improving outcomes of HIV- diagnosis and treatment in pregnancy is unknown. Our proposal seeks to address these key gaps in the evidence base and guide scale-up by evaluating a promising male engagement intervention (“Homens para Saúde” (HoPS)+ [Men for Health]) targeting EMTCT in Mozambique through a clinic-randomized trial. We will engage 24 ANC clinics; 12 intervention and 12 standard of care, with 40 HIV-infected couples per clinic where currently >60% of couples attend their first ANC visit together. The planned intervention addresses social- structural and cultural factors influencing EMTCT through the creation of couples-centered integrated HIV services, including: (1) ANC-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couple-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. Given that 8.0% of all pregnant women and 7.2% of their partners tested HIV-positive during ANC visits in 2015 (FGH monitoring and evaluation [M&E] data), our pioneering work in Mozambique's rural Zambézia province suggests that innovative strategies are essential to engaging HIV-infected male partners in antenatal care (ANC) in order to achieve EMTCT and to improve substantially the health of the mothers. Our team of Mozambican and U.S. investigators has a proven record of international HIV research success and we have specific recent experience with EMTCT cluster randomized trials, male-engagement in ANC services, and cost-effectiveness analysis of HIV programs. The specific aims of this study are: (1) To implement and evaluate the impact of male-engaged, couples-centered services on retention in care, adherence to ART, and early infant diagnosis among HIV+ pregnant women and their HIV+ male partners through a cluster-randomized RCT; (2) To investigate the impact of HoPS+ on hypothesized mechanisms of change; and (3) To use validated simulation models to evaluate cost-effectiveness of the HoPS+ intervention with the use of programmatic provincial M&E data and data from our trial results.