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HIVNCT06340698

Boosting the HRQoL Among HIV+ Mothers and Children

A study testing Resilience intervention and Adherence intervention in people with HIV and Perinatal HIV Infection, run by City University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
HIV, Perinatal HIV Infection
What is being tested?
Resilience intervention and Adherence intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteChina
Study dates
7 Jul 2024to 11 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Guangxi Center for Disease Prevention and Control

    Nanning, Guangxi, 530027

Other trials in China

About this study

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

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:

Read more
  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.

Being tested
Resilience intervention, Adherence intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resilience interventionBehavioural

    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 interventionBehavioural

    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.
Study groups in NCT06340698
Study groupRoleWhat they receive
Resilience interventionExperimentalParticipants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention.
Receives: Behavioral: Resilience intervention
Adherence interventionExperimentalParticipants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention.
Receives: Behavioral: Adherence intervention
ControlNo interventionParticipants will receive usual medical treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of health-related quality of life (HRQoL)

    HRQoL will be measured by the Chinese short version of the World Health Organization Quality of Life (Whoqol Group, 1998). Possible scores range from 0 (worst HRQoL) to 104 (Best HRQoL).

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  2. Change of depressive symptoms

    Depressive symptoms will be measured by the Patient Health Questionnaire-9 (Kroenke, Spitzer, \& Williams, 2001). Possible scores range from 0 to 27, with a higher score indicating more depressive symptoms.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  3. Change of anxiety symptoms

    Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-item version (Spitzer et al., 2006). Possible scores range from 0 to 21, with a higher score indicating more anxiety symptoms.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  4. Change of resilience factors

    Resilience factors will be measured by the 25-item Connor-Davidson Resilience Scale (Connor \& Davidson, 2003). Possible scores range from 0 to 100, with a higher score indicating better resilience.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  5. Change of HAART adherence

    Adherence will be measured by (a) a visual analog scale asking the level of adherence (Zhang et al., 2020). Possible scores range from 0 (never adhere) to 10 (always adhere); and (b) single-item questions asking about missing and delayed doses in the last three days, seven days (one week) and 30 days (one month). Children will be asked to report their own adherence behaviors, and mothers will be asked to report both their own and their children's.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  6. Change of mediators in the resilience intervention: Perceived stigma

    Perceived stigma will be assessed by the 8-item HIV Stigma Scale (Berger et al., 2001; Li et al., 2016). Possible scores range from 8 to 32, with a higher score indicating a higher level of perceived stigma.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  7. Change of mediators in the resilience intervention: Emotional regulation

    Emotional regulation will be assessed by the Emotional Management Strategy Questionnaire (Fabrizio et al., 2015). Possible scores range from 10 (worst emotional regulation) to 60 (best emotional regulation).

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  8. Change of mediators in the resilience intervention: Positive coping

    Positive coping will be assessed by a combination of the positive reappraisal subscale from the Cognitive Emotion Regulation Questionnaire (Garnefski et al., 2002; Zhu et al., 2008) and the Emotional Processing Subscale from the Emotional Approach Coping Scales (Stanon et al., 2000; Tse et al., 2020). Possible scores range from 8 to 40, with a higher score indicating better positive coping.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  9. Change of mediators in the resilience intervention: Social support

    Social support will be assessed by a combination of the Perceived Social Support Scale (Blumenthal et al., 1987; Huang, Jiang, \& Ren, 1996), the possible scores of which range from 0 (lowest level of support) to 72 (highest level of support), and the usage of support subscale of the Social Support Assessment Scale (Xiao \& Yang, 1987), the possible scores of which range from 3 (lowest level of support utilization) to 12 (highest level of support utilization)

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  10. Change of mediators in the resilience intervention: Self-efficacy

    Self-efficacy will be assessed by the General Self-Efficacy Scale (Schwarzer \& Aristi, 1997). Possible scores range from 10 to 40, with a higher score indicating a higher level of efficacy.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  11. Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills

    Adherence information, motivation, and behavioral skills will be assessed by the LifeWindows Information-Motivation-Behavioral Skills Antiretroviral Therapy Adherence Questionnaire (LifeWindows Project Team, 2006; Peng et al., 2020). Possible scores of the information, motivation, and behavioral skills subscale range from 9 to 45, 8 to 40, and 13 to 65, respectively, with a higher score indicating a higher level of information, motivation, and behavioral skills.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  12. Change of mediators in the adherence intervention: Illness perception

    Illness perception will be assessed by the Brief Illness Perception Questionnaire (Broadbent et al., 2006). Possible scores of each of the eight items range from 0 to 10, and each item will be used separately.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  13. Change of mediators in the adherence intervention: Adherence efficacy

    Adherence efficacy will be assessed by the HIV Treatment Adherence Self-Efficacy Scale (Johnson et al., 2007; Sun et al., 2016). Possible scores range from 0 to 120, with a higher score indicating a higher level of perceived efficacy.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

  14. Change of mediators in the adherence intervention: Children's medication-taking responsibility

    Children's medication-taking responsibility perception and allocation (between mother and child) will be assessed by two visual analog scales respectively. Possible scores of each item range from 0 to 10, with a higher score indicating more self-responsibility than mother-responsibility.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention)

Secondary outcomes (5)
  1. Change of mother-child relationship and interaction: Dyadic coping

    Dyadic coping will be assessed by two subscales from the Dyadic Coping Inventory (Bodenmann, 2008), namely the common dyadic coping and the evaluation of the dyadic coping subscale. Possible scores range from 7 to 35, with a higher score indicating a higher level of dyadic coping.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  2. Change of mother-child relationship and interaction: Mother-child closeness

    Mother-child closeness will be assessed by the Closeness subscale of the Network of Relationships-Relationship Quality Version (Buhrmester \& Furman, 2008; Kong et al., 2012), the possible scores of which range from 15 (lowest level of closeness) to 90 (highest level of closeness) and the Inclusion of Other in the Self Scale (Aron, A., Aron, N., \& Smollan, 1992), the possible scores of which range from 1 (lowest level of closeness) to 7 (highest level of closeness).

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  3. Change of mother-child relationship and interaction: Family harmony

    Family harmony will be assessed by the Family Harmony Scale (Kavikondala et al., 2016). Possible scores range from 10 to 60, with a higher score indicating a higher level of harmony.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  4. Change of mother-child relationship and interaction: Mother-child conflict

    Mother-child conflict will be measured by the frequency and intensity of parent-child conflicts (Yau \& Smetana, 1996), the possible scores of which range from 2 (no conflict) to 10 (highest level of conflict).

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

  5. Change of mother-child relationship and interaction: Relationship satisfaction

    Relationship satisfaction will be assessed by a single-item relationship ladder. Possible scores range from 0 to 10, with a higher score indicating a higher level of satisfaction.

    Measured: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start7 Jul 2024
  3. Primary completion1 Sep 2025
  4. Study completion11 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340698
Sponsor's protocol ID
GRF-11606221
Status last verified
Feb 2026
First submitted
24 Mar 2024
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Resilience intervention and Adherence intervention in people with HIV and Perinatal HIV Infection, run by City University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of health-related quality of life (HRQoL) (time frame: Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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