Clinical trial NCT06340698: Boosting the HRQoL Among HIV+ Mothers and Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Perinatal HIV Infection
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 180
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 (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 criteria: 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.

Primary outcomes:
measure: Change of health-related quality of life (HRQoL)
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of depressive symptoms
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of anxiety symptoms
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of resilience factors
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of HAART adherence
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of mediators in the resilience intervention: Perceived stigma
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the resilience intervention: Emotional regulation
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the resilience intervention: Positive coping
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the resilience intervention: Social support
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the resilience intervention: Self-efficacy
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the adherence intervention: Illness perception
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the adherence intervention: Adherence efficacy
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
measure: Change of mediators in the adherence intervention: Children's medication-taking responsibility
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention)
Secondary outcomes:
measure: Change of mother-child relationship and interaction: Dyadic coping
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of mother-child relationship and interaction: Mother-child closeness
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of mother-child relationship and interaction: Family harmony
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of mother-child relationship and interaction: Mother-child conflict
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
measure: Change of mother-child relationship and interaction: Relationship satisfaction
timeFrame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Center for Disease Prevention and Control
state: Guangxi
Study officials:
affiliation: City University of Hong Kong
name: Xiaonan N. Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: