An RCT to Improve HRQoL of HIV+ Mothers and Children

HIV Clinical Trial

Official title:

Joint Forces to Combat HIV: A Randomized Controlled Trial to Improve the Health-related Quality of Life of HIV-positive Mothers and Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340698
• Other study ID #: GRF-11606221
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: City University of Hong Kong
• Contact: Xiaonan N. Yu, Dr.
• Phone: 34429436
• Email: nancy.yu[@]cityu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: 1. Whether baseline resilience and treatment adherence are associated with the HRQoL; 2. 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; 3. 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; 4. 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; 5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. the child is HIV positive and perinatally infected, and receives HAART;

2. the biological mother of the child is HIV positive and receives HAART;

3. the mother is a primary caregiver of the child.

Exclusion Criteria:

1. cannot complete the assessment due to a low education level or physical constraints;

2. have been diagnosed with another life-threatening disease (e.g., cancer);

3. have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Perinatal HIV Infection

Intervention

Behavioral:
• Resilience intervention
Contents of the first session include: Resilience. Know the concept of resilience. Stigma management. Discuss stigma experience and learn stigma management strategies such as normalizing the disease. Self-efficacy. Learn ways of improving self-efficacy, such as experience of success and social support. Contents of the second session include: Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions. Learn effective communication skills. Acquiring social support. Know people and resources that could provide support when having HIV-related difficulties and mental health problems. Emotional regulation. Understand the physiological responses to emotions. Know a range of emotional regulation strategies, such as cognitive reappraisal and deep breathing.
• Adherence intervention
Contents of the first session include: Adherence behavioral skills. Identify barriers to optimal HAART adherence. Know behavioral skills that can deal with these barriers, such as forgetting, afraid of others' questioning and side effects. Adherence information and motivation. Know how the HIV virus attack human body and the mechanisms of HAART medication. Understand the influence of adherence level on health outcomes. Contents of the second session include: Adherence motivation. Discuss possibilities and hope of future life, intimate relationship and career. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions concerning HAART medication. Learn effective communication skills. Acquiring social support. Know people and resources that could provide support when having HAART-related difficulties and problems.

Locations

Country	Name	City	State
China	Guangxi Center for Disease Prevention and Control	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
City University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of health-related quality of life (HRQoL)	HRQoL will be measured by the Chinese version of the WHOQOL-BREF questionnaire (Whoqol Group, 1998). Possible scores range from 0 (worst HRQoL) to 104 (Best HRQoL).	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Primary	Change of depressive and anxiety symptoms	Depressive symptoms will be measured by the PHQ-9 (Kroenke, Spitzer, & Williams, 2001). Possible scores range from 0 to 27, with a higher score indicating more depressive symptoms. Anxiety symptoms will be measured by the GAD-7 questionnaire (Spitzer et al., 2006). Possible scores range from 0 to 21, with a higher score indicating more anxiety symptoms.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Primary	Change of resilience factors	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.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Primary	Change of HAART adherence	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.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Primary	Change of mediators in the resilience intervention: Perceived stigma	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the resilience intervention: Emotional regulation	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).	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the resilience intervention: Positive coping	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the resilience intervention: Social support	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)	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the resilience intervention: Self-efficacy	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the adherence intervention: Illness perception	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the adherence intervention: Adherence efficacy	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Primary	Change of mediators in the adherence intervention: Children's medication-taking responsibility	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.	Baseline, 2 weeks (immediately after the last session of intervention)
Secondary	Change of mother-child relationship and interaction: Dyadic coping	Dyadic coping will be assessed by two subscales from the Dyadic Coping Inventory (Bodenmann, 2008), namely the common dyadic coping and the evaluation of the dyadic coping subscale. Possible scores range from 7 to 35, with a higher score indicating a higher level of dyadic coping.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Secondary	Change of mother-child relationship and interaction: Mother-child closeness	Mother-child closeness will be assessed by the Closeness subscale of the Network of Relationships-Relationship Quality Version (Buhrmester & Furman, 2008; Kong et al., 2012), the possible scores of which range from 15 (lowest level of closeness) to 90 (highest level of closeness) and the Inclusion of Other in the Self Scale (Aron, A., Aron, N., & Smollan, 1992), the possible scores of which range from 1 (lowest level of closeness) to 7 (highest level of closeness).	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Secondary	Change of mother-child relationship and interaction: Family harmony	Family harmony will be assessed by the Family Harmony Scale (Kavikondala et al., 2016). Possible scores range from 10 to 60, with a higher score indicating a higher level of harmony.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Secondary	Change of mother-child relationship and interaction: Mother-child conflict	Mother-child conflict will be measured by the frequency and intensity of parent-child conflicts (Yau & Smetana, 1996), the possible scores of which range from 2 (no conflict) to 10 (highest level of conflict).	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Secondary	Change of mother-child relationship and interaction: Relationship satisfaction	Relationship satisfaction will be assessed by a single-item relationship ladder. Possible scores range from 0 to 10, with a higher score indicating a higher level of satisfaction.	Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months