Integrating HIV and Depression Self Care to Improve Adherence in Perinatal Women

整合艾滋病毒和抑郁症自我护理以提高围产期妇女的依从性

• 批准号: 8602661
• 负责人: Nancy R Reynolds
• 金额: $ 20.44万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602661
• 关键词: AIDS clinical trial group; Address; Adherence; Adverse effects; Area; Attention; Behavior; Car Phone; Caring; Child; Child Care; Child health care; Clinic; Clinical; Comorbidity; Complication; Coping Skills; Counseling; Country; Development; Developmental Delay Disorders; Disease; Education; Experimental Designs; Gender; HIV; HIV-1; Health; Health Priorities; Health Services; Health behavior; Health behavior outcomes; Healthcare; Home environment; India; Infant; Informal Social Control; Intervention; Intervention Studies; Knowledge; Language; Life; Maternal Health; Maternal and Child Health; Measures; Medical; Mental Depression; Mental Health; Modeling; Mood Disorders; Mothers; Office Nursing; Outcome; Participant; Patients; Perinatal; Perinatal Care; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Postpartum Period; Problem Solving; Procedures; Process; Protocols documentation; Provider; Public Health; RNA; Randomized; Randomized Controlled Trials; Research; Resources; Risk; Role; Rural; Self Care; Services; Staging; System; Target Populations; Telephone; Testing; Text; Time; Training; Visit; Woman; Women' s Health; adverse outcome; care seeking; daily functioning; depressive symptoms; efficacy trial; evidence base; global health; high risk; improved; innovation; intervention effect; literacy; medication compliance; men; multi-component intervention; neglect; novel; pilot trial; public health relevance; rural area; social stigma; theories; treatment adherence; urban area

DESCRIPTION (provided by applicant): Women in low-resource countries are at high risk for co-morbid HIV and perinatal depression, yet are the least likely to obtain mental health and HIV treatment services because of a variety of personal, practical and organizational constraints. Independently, HIV and perinatal depression place women and their children at risk for poor health outcomes; together, these co-morbidities interact to compound the risk, having serious consequences for maternal, child, and public health outcomes. The proposed study will directly address this important, but neglected area by evaluating the feasibility and preliminary efficacy of an innovative intervention approach, BEST-maCARE [Better Education, Support, Treatment for maternal Capacity, Adherence, REtention in care]. The multi-component intervention is integrated into routine perinatal care and uses adjunctive mobile phone counseling, a promising, sustainable way to reach and engage women with co-morbid conditions in care and improve health outcomes. Most mobile phone interventions tested in limited-resource settings have relied on SMS text messaging. A phone counseling approach appears to be a more suitable for addressing the health challenges faced by women in resource-limited settings because many women have difficulties deciphering even simple text messages given literacy and language barriers. The intervention approach has been found effective in improving adherence and self-care behavior of persons living with HIV in the U.S., but its usefulness in addressing significant gaps in care among women with co-morbid conditions in a different socio-cultural, limited resource setting has not been examined. This project will use an evidence- based, time and resource-efficient process (ADAPT-ITT) to modify the intervention for delivery in different socio-cultural setting than originally created. The study will be conducted over two years in Bangalore, India, an ideal setting given high rates of depression and HIV among women, wide spread use of mobile phones in rural and urban areas, and fitting bi-national, complementary expertise of the multi-disciplinary team. During the first year we conduct elicitation research with patients and providers (n=35) in antenatal public clinics in Bangalore to deepen our understanding of the understanding of dynamics of risk among women embedded in socio-culturally constrained roles and leverage points for intervention. During the second year of the project, in accordance with the aims of a Stage Ib pilot trial, we will conduct test the feasibility and explore preliminay effect of the intervention to prepare for a full scale efficacy trial (R01). We will employ a two-am randomized between-groups experimental design (Best-maCare versus an attention control condition) and examine standardized, repeated dependent measures of clinical outcomes and process variables at 5 time points over 24-weeks.

描述（由申请人提供）：低资源国家的妇女患艾滋病毒和围产期抑郁症的风险很高，但由于各种个人，实用和组织的限制，获得心理健康和艾滋病毒治疗服务的可能性最低。独立地，艾滋病毒和围产期抑郁症使妇女及其子女面临健康状况不佳的风险。这些合并症共同互动以加剧风险，对产妇，儿童和公共卫生结果产生严重影响。拟议的研究将直接通过评估创新干预方法，最佳马acare的可行性和初步疗效来直接解决这一重要但被忽视的领域[更好的教育，支持，对孕产妇的能力，依从性，保留保留率]。多组分干预措施被整合到常规的围产期护理中，并使用辅助手机咨询，这是一种有前途的，可持续的方式，可以接触并吸引患有护理状况并改善健康结果的妇女。在限量资源设置中测试的大多数手机干预措施都依赖于SMS文本消息传递。电话咨询方法似乎更适合于解决资源有限的环境中女性面临的健康挑战，因为许多女性在识字和语言障碍的情况下也很难解密甚至简单的短信。人们发现，这种干预方法有效地改善了美国艾滋病毒携带者的依从性和自我保健行为，但在解决不同社会文化，有限的资源环境中，尚未检查其在解决患有合并状况的妇女中的巨大护理差距方面的有用性。该项目将使用基于证据的，时间和资源效率的过程（Adapt-ITT）来修改与最初创建的不同社会文化环境中交付的干预措施。这项研究将在印度班加罗尔进行两年的时间，鉴于妇女的抑郁症和艾滋病毒率高，在农村和城市地区广泛使用手机，以及合适的多学科团队的互补专业知识。在第一年，我们对班加罗尔产前公共诊所的患者和提供者（n = 35）进行引发研究，以加深我们对嵌入社会文化约束角色中嵌入的妇女中风险动态的理解，并利用干预点进行干预。在项目的第二年，根据IB阶段试验试验的目的，我们将测试可行性并探索干预措施的预先效应，以准备进行全尺度效能试验（R01）。我们将采用两种AM随机的组间实验设计（最佳武器与注意力控制条件），并检查标准化的，重复的临床结果和过程变量，在24周以上的5个时间点。