NCT06340698

Boosting the HRQoL Among HIV+ Mothers and Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: City University of Hong Kong · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Perinatal HIV Infection

Interventions

Type	Name	Description
BEHAVIORAL	Resilience intervention	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.
BEHAVIORAL	Adherence intervention	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.

Timeline

• Start date: 2024-07-07
• Primary completion: 2025-09-01
• Completion: 2026-01-11
• First posted: 2024-04-01
• Last updated: 2026-02-25

Locations

1 site across 1 country: China