Assessment of Group Peer Support to Children With HIV in Vietnam

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Karolinska Institutet
Sponsor:
Collaborator:
Hanoi Medical University
Information provided by (Responsible Party):
Mattias Larsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02035969
First received: December 17, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus (HIV)
Behavioral: Enhanced Treatment Support (ETS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Virological treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    HIV viral load of 1000 copies/ml


Secondary Outcome Measures:
  • Immunological treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • No rise in CD4+ T-cell count after 1 year of treatment
    • 50% decline compared to the highest value
    • CD4+ T-cell count below 100


Other Outcome Measures:
  • Clinical treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Occurence or recurrence of stage 4 diseases or conditions after at least 6 months of therapy


Estimated Enrollment: 520
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional treatment (CT)
Treatment 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
Experimental: Enhanced Treatment Support (ETS)
Treatment 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.
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children already on first line ART

Exclusion Criteria:

  • Children age above 12 years
  • Children with institutionalized parents
  • Children whose sibling are already included
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035969

Contacts
Contact: Mattias Larsson, MD, PhD +46707663068 Mattias.Larsson@ki.se
Contact: Nguyen Thi Kim Chuc, Ass. Prof. NTKChuc@yahoo.com

Locations
Vietnam
Hanoi Medical University Recruiting
Hanoi, Vietnam, 01
Contact: Nguyen Thi Kim Chuc, Ass. Prof       NTKChuc@yahoo.com   
Principal Investigator: Mattias Larsson, MD,PhD         
Principal Investigator: Nguyen Thi Kim Chuc, Assoc. Prof         
Sub-Investigator: Pham Nhat An, Prof.         
Sub-Investigator: Do Duy Cuong, Dr         
Sub-Investigator: Tran Chi Thanh, Msc         
Sponsors and Collaborators
Karolinska Institutet
Hanoi Medical University
Investigators
Principal Investigator: Mattias Larsson, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Mattias Larsson, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02035969     History of Changes
Other Study ID Numbers: K2012-56X-22028-01-3
Study First Received: December 17, 2013
Last Updated: January 13, 2014
Health Authority: Vietnam: Ministry of Health

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 15, 2014