Clinical Trials

MainTitle

Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland (FAM-CARE)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2019 by Elizabeth Glaser Pediatric AIDS Foundation

Sponsor
Elizabeth Glaser Pediatric AIDS Foundation

Collaborator
United States Agency for International Development (USAID)
Ministry of Health, Swaziland

Information provided by (Responsible Party)
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier
NCT03397420

First received: January 2, 2018
Last updated: January 14, 2019
Last Verified: January 2019
History of Changes
Purpose

Purpose

The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program (where all HIV-positive family members are seen together as a unit and receive care together) on viral suppression and retention in HIV-positive children <15 years through enrollment of a prospective cohort of 660 HIV-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).

Condition Intervention
HIV Infections

Other : FAM-CARE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Family-centered Model of HIV Care (FAM-CARE) on Viral Suppression and Retention in Care of HIV-positive Children in Swaziland

Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:

Primary Outcome Measures

  • Proportion of HIV-positive children on ART virally suppressed [ Time Frame: 18 months after study enrollment. ]
    Proportion of HIV-positive children on ART with viral suppression (defined as HIV RNA copies/mL below the level of assay detection) and the proportion with HIV RNA <1,000 copies/mL at 18 months after enrollment
  • Proportion of HIV-positive on ART virally unsuppressed [ Time Frame: 18 months after study enrollment. ]
    Proportion of HIV-positive children on ART with HIV RNA >1000 copies/mL 18 months after enrollment into the study.
Secondary Outcome Measures:
  • Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment [ Time Frame: 6 and 12 months after study enrollment ]
    Proportion of HIV-positive children on ART with viral suppression (defined as HIV RNA copies/mL below the level of assay detection) and HIV RNA >1000 copies/mL
  • Factors associated with HIV viral suppression [ Time Frame: 18 months after study enrollment ]
    Individual and family factors associated with viral suppression.
  • Loss to follow-up [ Time Frame: 18 months after study enrollment ]
    Loss to follow-up (not seen in clinical care >3 months)
  • ART initiation [ Time Frame: 18 months after study enrollment ]
    ART initiation in HIV-positive children not on ART at study entry
  • Acceptability of the FAM-CARE program based on individual interview responses [ Time Frame: 18 months after study enrollment ]
    Acceptability of the FAM-CARE program to caregivers and health care provider as measured from responses on individual interviews using a structured questionnaire

Estimated Enrollment: 660
Study Start Date: September 13, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: FAM-CARE
Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program (where all HIV-positive family members are seen together as a unit and receive care together) with viral load monitoring
Other: FAM-CARE

Family-centered care, where all HIV-positive family members are seen together as a unit and receive HIV care and treatment services together, for HIV-positive children and their caregivers

Active Comparator: Control Standard of Care
Two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care (usual practice) sites. Standard HIV care and treatment services, (drug resupply, clinical assessments etc.), including viral load monitoring, will be provided to adults and children in separate adult and pediatric clinics, even though they many be from the same family.
Other: FAM-CARE

Family-centered care, where all HIV-positive family members are seen together as a unit and receive HIV care and treatment services together, for HIV-positive children and their caregivers

Detailed Description:

The proposed study will evaluate the effect of implementing a FAM-CARE program on viral suppression and retention in children through enrollment of a prospective cohort of HIV-positive children and their caregivers at sites implementing the FAM-CARE program and control sites continuing the current standard of care. The study will be conducted in four "clusters" of facilities (2 hospitals and 2 health centers and their filter clinics) in the Hhohho region of Swaziland. Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program with viral load monitoring and two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care sites. A prospective cohort of HIV-positive children and their caregivers will be followed in the FAM-CARE program sites and control sites. Each child will be followed for 18 months following enrollment. The primary objective is to evaluate the effect of the FAM-CARE program on the rates of viral suppression and retention in care, comparing rates of viral suppression and retention in children enrolled in FAM-CARE versus control sites. The study will also evaluate factors associated with viral suppression and retention (including family demographic characteristics), and conduct qualitative interviews to assess the acceptability of the FAM-CARE program by caregivers and health care providers in the intervention sites.

Eligibility

Eligibility

Ages Eligible for Study: up to 14 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • HIV-positive child aged <15 years receiving HIV care at the study facility.


Exclusion Criteria:
  • At least one family member residing in the household is also HIV-positive and is
receiving services at the study facility

contacts and locations

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: NCT03397420

Contacts

Contact:   Caspian Chouraya, MD +268.2404.8081 cchouraya@pedaids.org

Locations

Swaziland
Mbabane Recruiting
Mbabane, Swaziland
Contact: Caspian Chouraya, MD

Sponsors and Collaborators

Elizabeth Glaser Pediatric AIDS Foundation
United States Agency for International Development (USAID)
Ministry of Health, Swaziland

Investigators

Principal Investigator: Caspian Chouraya, MD Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Nobuble Mthethwa, MD Ministry of Health, Swaziland
Principal Investigator: Lynne Mofenson, MD Elizabeth Glaser Pediatric AIDS Foundation
More Information

More Information


Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation  
ClinicalTrials.gov Identifier: NCT03397420   History of Changes  
Other Study ID Numbers: EG0168  
Study First Received: January 2, 2018  
Last Updated: January 14, 2019  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on July 22, 2019
This information is provided by ClinicalTrials.gov.