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An RCT to Improve HRQoL of HIV+ Mothers and Children

An RCT to Improve HRQoL of HIV+ Mothers and Children

Recruiting
10-17 years
All
Phase N/A

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Overview

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

Inclusion Criteria:

  1. the child is HIV positive and perinatally infected, and receives HAART;
  2. the biological mother of the child is HIV positive and receives HAART;
  3. the mother is a primary caregiver of the child.

Exclusion Criteria:

  1. cannot complete the assessment due to a low education level or physical constraints;
  2. have been diagnosed with another life-threatening disease (e.g., cancer);
  3. have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.

Study details
    HIV
    Perinatal HIV Infection

NCT06340698

City University of Hong Kong

16 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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