Relationship Factors and HIV Treatment Adherence

描述（由申请人提供）：此竞争性续期申请建立在我们的项目“关系因素和艾滋病毒治疗依从性”（R01NR010187）的成功基础上，也称为“Duo项目”。迄今为止，父母补助金是成功的，过程和结果为这次延期申请的目的提供了信息。处于初级关系中通常被认为是导致后勤和情感支持，提供健康促进的好处。然而，有证据表明，处于初级关系中可能会导致行为，情绪和冲突，这可能会阻碍遵守规定的治疗方案。在使用二元数据分析和保持夫妇作为分析单位的同时，在社会控制理论中框架我们的工作将最大限度地了解夫妇互动如何影响依从性。迄今为止，我们的工作记录了伴侣动态和依从性之间的关联，并建议随着时间的推移研究夫妻的重要性，以最好地了解关系因素和ART依从性的动态相互作用。因此，我们现在建议通过混合定性，定量和随机对照试验（RCT）方法来扩展这项工作。目前的3期研究是对男性夫妇的横断面调查，以检验个人水平变量（例如，关于治疗功效、物质使用和依从性自我功效的信念）和夫妇水平变量（例如，关系满意度、冲突和依从性特异性伴侣支持），以及药物依从性和临床变量。为了优化对依从性和社会关系文献的贡献，我们建议在6个月、12个月、18个月和24个月时对这些夫妇进行重复评估，以检验纵向假设。我们将有目的地选择夫妇进行深入的定性访谈，以进一步将我们的发现置于背景中并为干预措施提供信息。最后，我们将开发和试点夫妇为基础的干预，双PACT（伙伴关系坚持承诺疗法），与32对夫妇（同样随机干预或评估仅控制），以确定可行性，满意度，并告知干预的更大试验的效果大小估计。三个经过充分验证的自我报告工具将测量所有参与者对ART的依从性，我们还将使用MEMS帽监测干预中的参与者，以引导后续更大RCT的程序。将通过超灵敏病毒载量和CD4计数测定评估临床状态。意义研究结果将有临床意义的检测依从性问题和进一步的发展，评估和传播的干预措施，以提高夫妻关系中的依从性。研究结果也将有理论意义的社会控制功能的背景下，坚持艾滋病毒药物治疗的非传统关系和不同的血清状态配置。

DESCRIPTION (provided by applicant): This competing renewal application builds upon the success of our project "Relationship Factors and HIV Treatment Adherence" (R01NR010187) also known as the "Duo Project". The parent grant has been successful thus far and the process and findings have informed the aims of this renewal application. Being in a primary relationship is generally accepted as resulting in logistic and emotional support that provides health- promoting benefits. However, there is evidence that being in a primary relationship may result in behaviors, emotions, and conflict that may hinder adherence to prescribed treatment regimens. Framing our work in Social Control Theory while using dyadic data analysis and maintaining the couple as the unit of analysis will maximize our understanding of how couple interactions affect adherence. Our work to date has documented associations between partner dynamics and adherence and has suggested the importance of studying couples over time to best understand the dynamic interplay of relationship factors and ART adherence. We are therefore now proposing to extend the work through mixed qualitative, quantitative and randomized controlled trial (RCT) methodologies. The current Phase 3 study is a cross-sectional investigation of male couples to test hypotheses of the interrelationships among individual-level variables (e.g., beliefs about treatment efficacy, substance use, and adherence self-efficacy) and couple-level variables (e.g., relationship satisfaction, conflict, and adherence-specific partner support), and medication adherence and clinical variables. To optimize the contribution to the adherence and social relationship literature, we propose to follow these couples with repeat assessments at 6, 12, 18 and 24 months to test longitudinal hypotheses. We will purposefully select couples for in-depth qualitative interviews to further contextualize our findings and to inform interventions. Finally, we will develop and pilot a couples-based intervention, Duo PACT (Partnership Adherence Commitment Therapy), with 32 couples (equally randomized to intervention or assessment only control) to determine feasibility, satisfaction, and to inform effect size estimates for a larger trial of the intervention. Three well- validated self-report instruments will measure adherence to ART in all participants, and we will also use MEMS caps monitoring with those in the intervention to pilot procedures for a subsequent larger RCT. Clinical status will be assessed by ultrasensitive viral load and CD4 count assays. Significance. Findings will have clinical implications for the detection of adherence problems and the further development, evaluation, and dissemination of interventions to improve adherence within the couple relationship. Study findings will also have theoretical implications for the function of social control in the context of adherence to HIV medications within non-traditional relationships and across different serostatus configurations.