Boosting the HRQoL Among HIV+ Mothers and Children

City University of Hong Kong

Status: Enrolling

Conditions: Perinatal HIV Infection; HIV

Treatments: Behavioral: Adherence intervention; Behavioral: Resilience intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06340698

GRF-11606221

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Resilience intervention

Experimental group

Description:

Participants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention.

Treatment:

Behavioral: Resilience intervention

Adherence intervention

Experimental group

Description:

Participants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention.

Treatment:

Behavioral: Adherence intervention

Control

No Intervention group

Description:

Participants will receive usual medical treatment.