BEHAVIORAL INTERVENTIONS FOR WOMEN WITH HIV/AIDS - NY

这项拟议的多地点临床试验的主要目标是继续努力制定最有效的行为干预措施组合，以优化该国受艾滋病流行影响的最被忽视和研究不足的人群的健康状况：感染艾滋病毒/艾滋病的贫穷有色人种妇女。目前对这一人群的研究结果证实了认知行为压力管理训练结合表达支持疗法（CBSM+）在减少痛苦（抑郁、焦虑）和否认方面的效用，同时提高了社会支持、自我效能、应对技能和生活质量。该研究将扩展这些发现，以确定CBSM+暴露是否能显著提高参与者利用健康行为改变计划的能力，该计划鼓励采用和维持更健康的生活方式行为（高水平的药物依从性，适当的营养摄入和身体活动，更安全的性行为和减少药物使用/滥用），这对艾滋病毒/艾滋病感染者的最佳健康至关重要。一个必然的目标将是确定拟议的干预方案是否有利于受影响人口中文化适应程度较低的部分（即感染艾滋病毒/艾滋病的非英语妇女），方法是建立西班牙语和克里奥尔语方案的文化和语言敏感版本。为了实现这些目标，拟议的III期多地点临床试验在两个相互关联的互动研究项目拨款申请（迈阿密- S. Weiss， P.I.；纽约/新泽西- J. Tobin， P.I.）中描述，将在三个主要的女性中心（迈阿密：n=180；纽约：n=180；新泽西：n=90）随机抽取450名不同种族的艾滋病毒/艾滋病妇女，分为群体CBSM+条件和个体心理教育比较条件（第一阶段）。在第一阶段之后，参与者将被随机分组或队列分配到“更健康的生活方式”技能培训项目或个人健康教育控制条件（第二阶段），致力于改善药物依从性，营养，身体活动，安全性行为和减少物质使用。随访评估将在治疗后6、12和24个月进行。

The principal objective of this proposed multisite clinical trial is to continue efforts to develop the most effective combination of behavioral interventions to optimize the health status of the most neglected and understudied population affected by the AIDS epidemic in this country: poor women of color living with HIV/AIDS. Findings from the current study with this population affirm the utility of cognitive-behavioral stress management training combined with expressive-supportive therapy (CBSM+) in reducing distress (depression, ,anxiety) and denial, while improving social support, self-efficacy, coping skills and quality of life. The proposed study will extend these findings in seeking to determine whether exposure to CBSM+ can significantly improve the ability of the participants to take advantage of a health behavior change program encouraging the adoption and maintenance of healthier lifestyle behaviors (high levels of medication adherence, appropriate nutritional intake and physical activity, safer sexual practices and reduced substance use/abuse) essential for optimal health in the context of living with HIV/AIDS. A corollary objective will be to determine whether the proposed intervention program will be beneficial to less-acculturated segments of the affected population (i.e., non-English speaking women with HIV/AIDS) by establishing culturally- and linguistically-sensitive versions of the program in Spanish and Creole. To accomplish these objectives, the proposed Phase III multisite clinical trial described in two linked interactive research project grant applications (Miami- S. Weiss, P.I.; New York/New Jersey- J. Tobin, P.I.) will randomize 450 ethically diverse women living with HIV/AIDS in the three major epicenters for women (Miami:n=180; New York:n=180; New Jersey:n=90) into a group CBSM+ Condition and an individual psychoeducational comparison condition (Phase I). Following Phase I, participants will be randomized by group or cohort into a group `Healthier Lifestyles' skills training program or an individual health educational control condition (Phase II) devoted to improving medication adherence, nutrition, physical activity, safer sex and substance use reduction. Follow-up assessments will be carried out at 6, 12, and 24 months after treatment.