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

对参加产前护理的血清一致夫妇进行基于伴侣的艾滋病毒治疗

• 批准号: 9346956
• 负责人: Carolyn Audet
• 金额: $ 68.71万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-12 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346956
• 关键词: Address; Adherence; Adopted; Adult; Africa; Africa South of the Sahara; African; Behavioral Mechanisms; CD4 Lymphocyte Count; Caring; Clinic; Clinical; Cluster randomized trial; Communities; Community Health Aides; Continuity of Patient Care; Cost Effectiveness Analysis; Counseling; Couples; Data; Diagnosis; Education; Effectiveness of Interventions; Eligibility Determination; Enrollment; Evaluation; Family; Friends; Goals; HIV; HIV Infections; HIV Seropositivity; HIV antiretroviral; HIV diagnosis; Health; Health Care Costs; Health Services; Health Services Accessibility; High Prevalence; Human immunodeficiency virus test; Individual; Infant; Infection; International; Intervention; Knowledge; Life; Monitor; Mother-to-child HIV transmission; Mothers; Mozambique; Participant; Patients; Postpartum Period; Pregnancy; Pregnant Women; Prevention; Process; Province; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resistance; Resources; Risk; Rosa; Rural; Services; Social support; South Africa; Surveys; Traditional Birth Attendants; Treatment outcome; Triad Acrylic Resin; Trust; Vertical Disease Transmission; Viral; Visit; Wages; Wife; Woman; Work; antenatal; antiretroviral therapy; arm; base; behavior change; care delivery; care systems; cohort; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; effective intervention; evidence base; experience; follow-up; global health; health data; health of the mother; improved; improved outcome; innovation; intervention program; literacy; male; male health; medication compliance; member; men; models and simulation; peer; point of care; programs; randomized trial; rural setting; scale up; skills; social; social stigma; standard of care; success; uptake

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.

项目摘要：在资源严重有限的农村地区，扩大服务，消除母婴传播 艾滋病毒的传播（EMTCT）未能提供有效的艾滋病毒检测和抗逆转录病毒治疗（ART） 南部非洲流行率最高地区的妇女的覆盖率。所有感染艾滋病毒的孕妇现在 符合终身抗逆转录病毒治疗（ART）的条件，无论CD 4+细胞计数（选项B+）如何，但保留在 通过选项B+方案注册的妇女仍然不是最理想的。在撒哈拉以南非洲（SSA）， 妇女需要得到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。 尽管男性参与可能会提高项目的覆盖率和依从性，但证据表明， * 为有效干预奠定基础，通过产前护理点让男性伴侣参与艾滋病毒检测和治疗 是非常有限的此外，这些战略是否确实具有成本效益，以改善艾滋病毒的结果， 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， 通过评估有希望的男性参与干预措施（“Homens帕拉 Saúde”（HoPS）+ [男性健康]）通过临床随机试验在莫桑比克开展针对EMTCT的研究。我们将 * 利用24个产前护理诊所; 12个干预和12个标准护理，每个诊所有40对艾滋病毒感染夫妇， 目前，超过60%的夫妇一起参加他们的第一次ANC访问。计划的干预措施涉及社会- 通过建立以夫妇为中心的综合艾滋病毒方案影响消除母婴传播的结构和文化因素 服务，包括：（1）基于ANC的夫妇艾滋病毒检测，ART登记，以及对血清一致的艾滋病毒+的护理 （2）产后期间以夫妇为基础的治疗;（3）以夫妇为基础的教育和 技能建设;（4）在专家-患者（同行）支持者的支持下， 他们成功地通过了EMTCT鉴于8.0%的孕妇和7.2%的伴侣 在2015年ANC访问期间检测出艾滋病毒呈阳性（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工作表明，创新战略是至关重要的， 让感染艾滋病毒的男性伴侣参与产前护理，以实现消除母婴传播， 基本上是母亲的健康。我们的莫桑比克和美国调查小组有着良好的记录， 国际艾滋病毒研究的成功，我们有具体的最近经验，EMTCT集群随机 试验，男性参与ANC服务，以及艾滋病毒项目的成本效益分析。具体目标 本研究的主要目的是：（1）实施和评估男性参与的，以夫妇为中心的服务对 艾滋病毒阳性孕妇及其艾滋病毒阳性者的护理保留、抗逆转录病毒疗法的坚持和婴儿早期诊断 通过随机整群随机对照试验，研究HoPS+对假设的 （3）使用经过验证的模拟模型来评估 HoPS+干预使用省级监测和评价数据和我们的试验结果数据。