Boosting the HRQoL Among HIV+ Mothers and Children

NCT06340698 | Completed

• 1 other identifier: GRF-11606221
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether baseline resilience and treatment adherence are associated with the HRQoL;
2. 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. 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. 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. 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.

Conditions

HIV; Perinatal HIV Infection

Outcome Measures

Primary Outcomes (14)

• Change of health-related quality of life (HRQoL)

  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).

  Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

• Change of depressive symptoms

  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.

  Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

• Change of anxiety symptoms

  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.

  Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

• 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

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• 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: 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: Relationship satisfaction

  Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

Study Arms (3)

Resilience intervention

EXPERIMENTAL

Participants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention.

Behavioral: Resilience intervention

Adherence intervention

EXPERIMENTAL

Participants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention.

Behavioral: Adherence intervention

Control

NO INTERVENTION

Participants will receive usual medical treatment.

Interventions

Resilience intervention BEHAVIORAL

Contents of the first session include: 1. Resilience. Know the concept of resilience. 2. Stigma management. Discuss stigma experience and learn stigma management strategies such as normalizing the disease. 3. Self-efficacy. Learn ways of improving self-efficacy, such as experience of success and social support. Contents of the second session include: 1. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions. Learn effective communication skills. 2. Acquiring social support. Know people and resources that could provide support when having HIV-related difficulties and mental health problems. 3. Emotional regulation. Understand the physiological responses to emotions. Know a range of emotional regulation strategies, such as cognitive reappraisal and deep breathing.

Resilience intervention

Adherence intervention BEHAVIORAL

Contents of the first session include: 1. 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. 2. 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: 1. Adherence motivation. Discuss possibilities and hope of future life, intimate relationship and career. 2. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions concerning HAART medication. Learn effective communication skills. 3. Acquiring social support. Know people and resources that could provide support when having HAART-related difficulties and problems.

Adherence intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (1)

Guangxi Center for Disease Prevention and Control

Nanning, Guangxi, 530027, China

Location

Study Officials

• Xiaonan N. Yu, Dr.

  City University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: July 7, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 11, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)