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: 9920212
• 负责人: Carolyn Audet
• 金额: $ 57.59万
• 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/9920212
• 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; 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; International; Intervention; Knowledge; Life; Monitor; Mother-to-child HIV transmission; Mothers; Mozambique; Participant; Patients; Personal Satisfaction; Postpartum Period; Pregnancy; Pregnant Women; Prevention; Process; Province; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resistance; Resources; Risk; 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 care; antiretroviral therapy; 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; neonatal infection; peer; point of care; programs; randomized trial; rural setting; scale up; skills; social stigma; social structure; standard of care; success; treatment arm; 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：在严格的资源有限的粗糙设置中，服务规模扩大以消除母亲到孩子 HIV（EMTCT）的传播未能提供有效的HIV检测和抗逆转录病毒疗法（ART） 南部非洲地区最高流行的妇女的覆盖范围。所有感染HIV的孕妇现在都是 有资格进行终身抗逆转录病毒疗法（ART），无论CD4+细胞计数如何 通过选项B+计划入学的妇女仍然是最佳选择。在撒哈拉以南非洲（SSA）中，这很常见 妇女需要男性伴侣批准才能获得并继续从事与HIV相关的卫生服务。 尽管男性参与可能会改善计划的覆盖范围和依从性，但证据 有效干预措施的基础，使男性伴侣通过ANC护理点参与HIV测试和治疗 非常有限。此外，这种策略是否确实具有成本效益，可以改善HIV的结果 怀孕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 通过评估承诺的男性参与干预措施，证据基础和指导量表（“ Homens para Saúde”（HOPS）+ [健康的男性]）通过诊所随机试验将EMTCT靶向莫桑比克。我们将 聘请24个ANC诊所； 12干预和12个护理标准，每个诊所有40对HIV感染的夫妇 目前，有60％的夫妇一起参加了他们的第一次ANC访问。计划的干预措施解决了社会 - 结构和文化因素通过以夫妻为中心的综合艾滋病影响EMTCT 服务，包括：（1）基于ANC的夫妇艾滋病毒测试，艺术入学和对血清康复的HIV+的护理 预期夫妇； （2）在产后时期基于夫妇的治疗； （3）基于夫妇的教育和 技能建设； （4）在夫妻的专家接受者（同伴）支持者的支持下进行处理的连续性 成功浏览EMTCT的人。鉴于所有孕妇中有8.0％和7.2％的伴侣 在2015年ANC访问期间测试了HIV阳性（FGH监测和评估[M＆E]数据），我们的开拓性 莫桑比克农村Zambézia省的工作表明，创新策略对于 吸引HIV感染的男性伴侣参与天然护理（ANC），以实现EMTCT并改善 基本上是母亲的健康。我们的莫桑比克和美国调查人员团队有一个可靠的记录 国际艾滋病毒研究成功，我们在EMTCT群集随机方面有具体的经验 试验，ANC服务中的男性参与以及艾滋病毒计划的成本效益分析。具体目标 这项研究的是：（1）实施和评估以男性为中心的服务对 保留艾滋病毒+孕妇及其艾滋病毒+的护理，遵守艺术和早期婴儿诊断 通过聚类的RCT进行男性伴侣； （2）研究啤酒花+对假设的影响 变革的机制； （3）使用经过验证的仿真模型来评估 通过使用程序化省级M＆E数据以及我们的试验结果中的数据和数据，啤酒花+干预措施。