Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340698
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-24
Brief Title:
Boosting the HRQoL Among HIV Mothers and Children
Sponsor:
City University of Hong Kong
Organization:
City University of Hong Kong
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 eg 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 eg 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
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 eg 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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None