protocolSection identificationModule nctId: NCT06340698, orgStudyIdInfo id: GRF-11606221, briefTitle: An RCT to Improve HRQoL of HIV+ Mothers and Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: City University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: HIV, conditions: Perinatal HIV Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Resilience intervention, interventions name: Adherence intervention, outcomesModule primaryOutcomes measure: Change of health-related quality of life (HRQoL), primaryOutcomes measure: Change of depressive and anxiety symptoms, primaryOutcomes measure: Change of resilience factors, primaryOutcomes measure: Change of HAART adherence, primaryOutcomes measure: Change of mediators in the resilience intervention: Perceived stigma, primaryOutcomes measure: Change of mediators in the resilience intervention: Emotional regulation, primaryOutcomes measure: Change of mediators in the resilience intervention: Positive coping, primaryOutcomes measure: Change of mediators in the resilience intervention: Social support, primaryOutcomes measure: Change of mediators in the resilience intervention: Self-efficacy, primaryOutcomes measure: Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills, primaryOutcomes measure: Change of mediators in the adherence intervention: Illness perception, primaryOutcomes measure: Change of mediators in the adherence intervention: Adherence efficacy, primaryOutcomes measure: Change of mediators in the adherence intervention: Children's medication-taking responsibility, secondaryOutcomes measure: Change of mother-child relationship and interaction: Dyadic coping, secondaryOutcomes measure: Change of mother-child relationship and interaction: Mother-child closeness, secondaryOutcomes measure: Change of mother-child relationship and interaction: Family harmony, secondaryOutcomes measure: Change of mother-child relationship and interaction: Mother-child conflict, secondaryOutcomes measure: Change of mother-child relationship and interaction: Relationship satisfaction, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Guangxi Center for Disease Prevention and Control, status: RECRUITING, city: Nanning, state: Guangxi, zip: 530027, country: China, contacts name: Xiaoliang Zeng, Dr., role: CONTACT, phone: +86 13457089643, email: 41045926@qq.com, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False