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

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ClinicalTrials.gov Identifier: NCT03397420
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Ministry of Health, Swaziland
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Other: FAM-CARE Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 742 participants
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
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. Factors associated with HIV viral suppression [ Time Frame: 18 months after study enrollment ]
    Individual and family factors associated with viral suppression.

  3. Loss to follow-up [ Time Frame: 18 months after study enrollment ]
    Loss to follow-up (not seen in clinical care >3 months)

  4. ART initiation [ Time Frame: 18 months after study enrollment ]
    ART initiation in HIV-positive children not on ART at study entry

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 14 Years   (Child)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397420


Locations
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Swaziland
Mbabane
Mbabane, Swaziland
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
United States Agency for International Development (USAID)
Ministry of Health, Swaziland
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT03397420    
Other Study ID Numbers: EG0168
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPDs
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Six months after study publication
Access Criteria: Datasets will be available for download upon request from Population Council/USAID website

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
HIV Seropositivity
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases