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NCT06340698Completed

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

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
130 (actual)
First submitted
24 Mar 2024
Start date
7 Jul 2024
Primary completion date
1 Sept 2025
Lead sponsor
City University of Hong Kong
Diseases
HIV
NCT number
NCT06340698

What you commit to

  • Study type: Interventional
  • Participants enrolled: 130
  • From 7 Jul 2024 to the primary completion date, 1 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • cannot complete the assessment due to a low education level or physical constraints;
  • have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.

Who the study is looking for

  • 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.

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangxi Center for Disease Prevention and Control
Coordinator of this site? Confirm its status
NanningChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.