Pilot Randomized Controlled Trial of Couple-based Intervention on Relationship Satisfaction and Quality of Life in HIV Male Serodiscordant Couples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Perceived Acceptability, Appropriateness, and Feasibility
研究概览
简要总结
This study aims to provide preliminary evidence of the efficacy of couple-based intervention over usual care in HIV serodiscordant couples in China. The investigators hypothesize that couple-based intervention would be more effective than usual care concerning both partners' quality of life and relationship satisfaction. The investigators also pilot the feasibility, acceptability, and appropriateness of the intervention content and implementation.
HIV serodiscordant couples in the intervention arm will receive three sessions of dyadic intervention. In contrast, couples in the control arm will receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Perceived Acceptability, Appropriateness, and Feasibility
时间窗: One month (immediately after the last session of intervention)
Perceived acceptability, appropriateness, and feasibility will be assessed using the 12-item Implementation Outcome Inventory (Weiner et al., 2017). Only couples in the intervention group will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing all items. The score range is 0-48. Higher scores indicate a higher level of acceptability, appropriateness, and feasibility.
Change of Health-related Quality of Life
时间窗: Baseline, one month (immediately after the last session of intervention), and two month
Health-related quality of life will be measured using the 24-item World Health Organization Quality of Life, which contains four domains (i.e., physical, psychological, social relationships, and environment) (WHO, 1998). Both partners will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing the scores for the four domains. The score range is 0-96. Higher scores indicate a higher level of quality of life.
Change of Relationship Satisfaction
时间窗: Baseline, one month (immediately after the last session of intervention), and two month
Relationship satisfaction will be assessed using the 4-item Couple Satisfaction Index (Funk \&Rogger, 2007). Both partners will answer this scale. Items are scored on a six-point scale (0-5). The total score for this scale is calculated by summing all items. The score range is 0-20. Higher scores indicate a higher level of relationship satisfaction.
次要结局
- Change of Well-being(Baseline, one month (immediately after the last session of intervention), and two month)
- Percentage of Couples Agreeing to Participate(Baseline)
- Change of We-disease Appraisal(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Antiretroviral therapy Adherence(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Dyadic Coping(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Depressive Symptoms(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Condom Use with Study Partner(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Active Listening(Baseline, one month (immediately after the last session of intervention), and two month)
- Change of Self-regulation in Relationship(Baseline, one month (immediately after the last session of intervention), and two month)
- Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions(One month (immediately after the last session of intervention))
研究者
Dr. Nancy Xiaonan Yu
Associate Professor
City University of Hong Kong