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

Effect of Family-centered Model of HIV Care (FAM-CARE) on Viral Suppression and Retention in Care of HIV-positive Children in Swaziland

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: FAM-CARE

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 Type: Interventional
• Enrollment (Actual): 742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Swaziland
  • Mbabane, Swaziland
    • Mbabane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of HIV-positive children on ART virally suppressed	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	18 months after study enrollment.
Proportion of HIV-positive on ART virally unsuppressed	Proportion of HIV-positive children on ART with HIV RNA >1000 copies/mL 18 months after enrollment into the study.	18 months after study enrollment.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: 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

Publications and helpful links

General Publications

• Ashburn K, Chouraya C, Khumalo P, Mpango L, Mthethwa N, Machekano R, Guay L, Mofenson LM. A randomized controlled trial evaluating the effects of a family-centered HIV care model on viral suppression and retention in care of HIV-positive children in Eswatini. PLoS One. 2021 Aug 24;16(8):e0256256. doi: 10.1371/journal.pone.0256256. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: EG0168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPDs
• IPD Sharing Time Frame: Six months after study publication
• IPD Sharing Access Criteria: Datasets will be available for download upon request from Population Council/USAID website
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No