Boosting the HRQoL Among HIV+ Mothers and Children

NCT ID: NCT06340698

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2025-02-28

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.

Conditions

HIV; Perinatal HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Resilience intervention

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

Group Type: EXPERIMENTAL

Resilience intervention

Intervention Type: BEHAVIORAL

Contents of the first session include:

1. Resilience. Know the concept of resilience.

2. Stigma management. Discuss stigma experience and learn stigma management strategies such as normalizing the disease.

3. Self-efficacy. Learn ways of improving self-efficacy, such as experience of success and social support.

Contents of the second session include:

1. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions. Learn effective communication skills.

2. Acquiring social support. Know people and resources that could provide support when having HIV-related difficulties and mental health problems.

3. Emotional regulation. Understand the physiological responses to emotions. Know a range of emotional regulation strategies, such as cognitive reappraisal and deep breathing.

Adherence intervention

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

Group Type: EXPERIMENTAL

Adherence intervention

Intervention Type: BEHAVIORAL

Contents of the first session include:

1. Adherence behavioral skills. Identify barriers to optimal HAART adherence. Know behavioral skills that can deal with these barriers, such as forgetting, afraid of others' questioning and side effects.

2. Adherence information and motivation. Know how the HIV virus attack human body and the mechanisms of HAART medication. Understand the influence of adherence level on health outcomes.

Contents of the second session include:

1. Adherence motivation. Discuss possibilities and hope of future life, intimate relationship and career.

2. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions concerning HAART medication. Learn effective communication skills.

3. Acquiring social support. Know people and resources that could provide support when having HAART-related difficulties and problems.

Control

Participants will receive usual medical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Resilience intervention

Contents of the first session include:

1. Resilience. Know the concept of resilience.

2. Stigma management. Discuss stigma experience and learn stigma management strategies such as normalizing the disease.

3. Self-efficacy. Learn ways of improving self-efficacy, such as experience of success and social support.

Contents of the second session include:

1. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions. Learn effective communication skills.

2. Acquiring social support. Know people and resources that could provide support when having HIV-related difficulties and mental health problems.

3. Emotional regulation. Understand the physiological responses to emotions. Know a range of emotional regulation strategies, such as cognitive reappraisal and deep breathing.

Intervention Type: BEHAVIORAL

Adherence intervention

Contents of the first session include:

1. Adherence behavioral skills. Identify barriers to optimal HAART adherence. Know behavioral skills that can deal with these barriers, such as forgetting, afraid of others' questioning and side effects.

2. Adherence information and motivation. Know how the HIV virus attack human body and the mechanisms of HAART medication. Understand the influence of adherence level on health outcomes.

Contents of the second session include:

1. Adherence motivation. Discuss possibilities and hope of future life, intimate relationship and career.

2. Mother-child interaction skills. Identify speaking styles that have a negative influence on mother-child interactions concerning HAART medication. Learn effective communication skills.

3. Acquiring social support. Know people and resources that could provide support when having HAART-related difficulties and problems.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nancy Xiaonan Yu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaonan N. Yu, Dr.

Role: PRINCIPAL_INVESTIGATOR

City University of Hong Kong

Locations

Guangxi Center for Disease Prevention and Control

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaonan N. Yu, Dr.

Role: CONTACT

nancy.yu@cityu.edu.hk

34429436

Xiaoliang Zeng, Dr.

Role: CONTACT

41045926@qq.com

+86 13457089643

Facility Contacts

Xiaoliang Zeng, Dr.

Role: primary

41045926@qq.com

+86 13457089643

Other Identifiers

GRF-11606221

Identifier Type: -

Identifier Source: org_study_id