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Assessment of Group Peer Support to Children With HIV in Vietnam

NCT02035969 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

BEHAVIORAL

Enhanced Treatment Support (ETS)

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.

Sponsors & Collaborators

Principal Investigators

  • Mattias Larsson, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2022-01-01
Completion
2022-01-04

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035969 on ClinicalTrials.gov