Joint Forces to Combat HIV: A Randomized Controlled Trial to Improve the Health-related Quality of Life (HRQoL) of HIV-positive Mothers and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change of health-related quality of life (HRQoL)
研究概览
简要总结
The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.
The main questions it aims to answer are:
- Whether baseline resilience and treatment adherence are associated with the HRQoL;
- Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
- Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
- Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups;
- Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups.
Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the child is HIV positive and perinatally infected, and receives HAART;
- •the biological mother of the child is HIV positive and receives HAART;
- •the mother is a primary caregiver of the child.
排除标准
- •cannot complete the assessment due to a low education level or physical constraints;
- •have been diagnosed with another life-threatening disease (e.g., cancer);
- •have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.
研究组 & 干预措施
Resilience intervention
Participants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention.
干预措施: Resilience intervention (Behavioral)
Adherence intervention
Participants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention.
干预措施: Adherence intervention (Behavioral)
Control
Participants will receive usual medical treatment.
结局指标
主要结局
Change of health-related quality of life (HRQoL)
时间窗: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
HRQoL will be measured by the Chinese short version of the World Health Organization Quality of Life (Whoqol Group, 1998). Possible scores range from 0 (worst HRQoL) to 104 (Best HRQoL).
Change of resilience factors
时间窗: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Resilience factors will be measured by the 25-item Connor-Davidson Resilience Scale (Connor \& Davidson, 2003). Possible scores range from 0 to 100, with a higher score indicating better resilience.
Change of HAART adherence
时间窗: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Adherence will be measured by (a) a visual analog scale asking the level of adherence (Zhang et al., 2020). Possible scores range from 0 (never adhere) to 10 (always adhere); and (b) single-item questions asking about missing and delayed doses in the last three days, seven days (one week) and 30 days (one month). Children will be asked to report their own adherence behaviors, and mothers will be asked to report both their own and their children's.
Change of mediators in the adherence intervention: Illness perception
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Illness perception will be assessed by the Brief Illness Perception Questionnaire (Broadbent et al., 2006). Possible scores of each of the eight items range from 0 to 10, and each item will be used separately.
Change of mediators in the resilience intervention: Positive coping
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Positive coping will be assessed by a combination of the positive reappraisal subscale from the Cognitive Emotion Regulation Questionnaire (Garnefski et al., 2002; Zhu et al., 2008) and the Emotional Processing Subscale from the Emotional Approach Coping Scales (Stanon et al., 2000; Tse et al., 2020). Possible scores range from 8 to 40, with a higher score indicating better positive coping.
Change of anxiety symptoms
时间窗: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-item version (Spitzer et al., 2006). Possible scores range from 0 to 21, with a higher score indicating more anxiety symptoms.
Change of mediators in the resilience intervention: Emotional regulation
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Emotional regulation will be assessed by the Emotional Management Strategy Questionnaire (Fabrizio et al., 2015). Possible scores range from 10 (worst emotional regulation) to 60 (best emotional regulation).
Change of mediators in the resilience intervention: Social support
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Social support will be assessed by a combination of the Perceived Social Support Scale (Blumenthal et al., 1987; Huang, Jiang, \& Ren, 1996), the possible scores of which range from 0 (lowest level of support) to 72 (highest level of support), and the usage of support subscale of the Social Support Assessment Scale (Xiao \& Yang, 1987), the possible scores of which range from 3 (lowest level of support utilization) to 12 (highest level of support utilization)
Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Adherence information, motivation, and behavioral skills will be assessed by the LifeWindows Information-Motivation-Behavioral Skills Antiretroviral Therapy Adherence Questionnaire (LifeWindows Project Team, 2006; Peng et al., 2020). Possible scores of the information, motivation, and behavioral skills subscale range from 9 to 45, 8 to 40, and 13 to 65, respectively, with a higher score indicating a higher level of information, motivation, and behavioral skills.
Change of mediators in the adherence intervention: Adherence efficacy
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Adherence efficacy will be assessed by the HIV Treatment Adherence Self-Efficacy Scale (Johnson et al., 2007; Sun et al., 2016). Possible scores range from 0 to 120, with a higher score indicating a higher level of perceived efficacy.
Change of depressive symptoms
时间窗: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Depressive symptoms will be measured by the Patient Health Questionnaire-9 (Kroenke, Spitzer, \& Williams, 2001). Possible scores range from 0 to 27, with a higher score indicating more depressive symptoms.
Change of mediators in the resilience intervention: Perceived stigma
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Perceived stigma will be assessed by the 8-item HIV Stigma Scale (Berger et al., 2001; Li et al., 2016). Possible scores range from 8 to 32, with a higher score indicating a higher level of perceived stigma.
Change of mediators in the resilience intervention: Self-efficacy
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Self-efficacy will be assessed by the General Self-Efficacy Scale (Schwarzer \& Aristi, 1997). Possible scores range from 10 to 40, with a higher score indicating a higher level of efficacy.
Change of mediators in the adherence intervention: Children's medication-taking responsibility
时间窗: Baseline, 2 weeks (immediately after the last session of intervention)
Children's medication-taking responsibility perception and allocation (between mother and child) will be assessed by two visual analog scales respectively. Possible scores of each item range from 0 to 10, with a higher score indicating more self-responsibility than mother-responsibility.
次要结局
- Change of mother-child relationship and interaction: Mother-child conflict(Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months)
- Change of mother-child relationship and interaction: Dyadic coping(Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months)
- Change of mother-child relationship and interaction: Mother-child closeness(Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months)
- Change of mother-child relationship and interaction: Family harmony(Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months)
- Change of mother-child relationship and interaction: Relationship satisfaction(Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months)
研究者
Dr. Nancy Xiaonan Yu
Associate Professor
City University of Hong Kong