Assessment of Group Peer Support to Children With HIV in Vietnam
A Randomized Controlled Trial to Assess the Effect of Group Peer Support to Children With HIV in Relation to Adherence, Virological Treatment Failure as Well as Physical Development
1 other identifier
interventional
520
1 country
1
Brief Summary
This project aims to assess the effect of group peer support to children with HIV in relation to adherence, virological treatment failure as well as physical development. A randomised controlled trial (RCT) will be used where HIV+ children on antiretroviral treatment (ARV) and their caretakers are randomized into either enhanced treatment support (ETS) through peer supporters or the conventional treatment (CT) according to the guidelines of The National AIDS Control Program. The treatment strategies will be assessed and compared in relation to virological treatment failure as primary endpoint, immunological and clinical (AIDS events and mortality) as secondary endpoints as well as treatment adherence and physical development. The results from this project will lead to an increased knowledge in relation to the impact of enhanced treatment support on adherence, virological suppression and resistance development for children with HIV and have an impact on HIV treatment policies and guidelines for Pediatric HIV in low-income settings globally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2022
CompletedFebruary 18, 2021
February 1, 2021
8.1 years
December 17, 2013
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Virological treatment failure
HIV viral load of 1000 copies/ml
24 months
Secondary Outcomes (1)
Immunological treatment failure
24 months
Other Outcomes (1)
Clinical treatment failure
24 months
Study Arms (2)
Conventional treatment (CT)
NO INTERVENTIONTreatment according to the National Treatment Guidelines in Vietnam including treatment counseling and clinical follow up every three months. The caretaker of the child is responsible that the child will take the drugs and is provided with a pre-packed dosage form for easy remembering
Enhanced Treatment Support (ETS)
EXPERIMENTALTreatment according to the National Treatment Guidelines in Vietnam including treatment counselling and clinical follow up every three months. In addition adherence support is provided according to the description under intervention.
Interventions
Peer supporters, who are also caregivers of HIV-infected children, organize peer support group meetings. In the meetings one peer supporter discusses problems related to adherence with caretakers and provides them with information. Another supporter provides children above 3 years of age with age relevant information about their disease and treatment as well as games and play to enhance group bounds. The supporter will also have weekly telephone contact with all caretakers to assess the condition of the child. For children with poor adherence individual support to caretakers and patients will be arranged to assess the child's condition and reason for poor adherence, in case of complications the supporter gives advice or refers the child for medical checkup.
Eligibility Criteria
You may qualify if:
- Children already on first line ART
You may not qualify if:
- Children age above 12 years
- Children with institutionalized parents
- Children whose sibling are already included
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Hanoi Medical Universitycollaborator
Study Sites (1)
Hanoi Medical University
Hanoi, 01, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mattias Larsson, MD, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 17, 2013
First Posted
January 14, 2014
Study Start
December 1, 2013
Primary Completion
January 1, 2022
Study Completion
January 4, 2022
Last Updated
February 18, 2021
Record last verified: 2021-02