Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland

NCT03397420 | Completed

• 1 other identifier: EG0168
• Study Type: interventional
• Target: 742
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment

  6 and 12 months after study enrollment

• Factors associated with HIV viral suppression

  18 months after study enrollment

• Loss to follow-up

  18 months after study enrollment

• ART initiation

  18 months after study enrollment

• Acceptability of the FAM-CARE program based on individual interview responses

  18 months after study enrollment

Study Arms (2)

FAM-CARE

EXPERIMENTAL

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

Control Standard of Care

ACTIVE COMPARATOR

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

Interventions

FAM-CARE OTHER

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

Control Standard of Care; FAM-CARE

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Mbabane

Mbabane, Eswatini

Location

Related Publications (1)

• 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.

  PMID: 34428241 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 12, 2018
• Study Start: September 13, 2017
• Primary Completion: October 30, 2018
• Study Completion: July 30, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Six months after study publication
• Access Criteria: Datasets will be available for download upon request from Population Council/USAID website

Locations

ES (1)