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: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Guangxi Center for Disease Prevention and Control
RECRUITING
Nanning
Contact Information
Primary
Xiaonan N. Yu, Dr.
nancy.yu@cityu.edu.hk
34429436
Backup
Xiaoliang Zeng, Dr.
41045926@qq.com
+86 13457089643
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-02
Participants
Target number of participants: 180
Treatments
Experimental: Resilience intervention
Participants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention.
Experimental: Adherence intervention
Participants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention.
No_intervention: Control
Participants will receive usual medical treatment.
Related Therapeutic Areas
Sponsors
Leads: City University of Hong Kong

This content was sourced from clinicaltrials.gov