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

NCT ID: NCT03397420

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 742 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2019-07-30

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).

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

FAM-CARE

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

FAM-CARE

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Ministry of Health, Swaziland

OTHER_GOV

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caspian Chouraya, MD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Nobuble Mthethwa, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Swaziland

Lynne Mofenson, MD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

Mbabane

Mbabane, , Eswatini

Countries

Eswatini

References

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.

Reference Type: DERIVED

PMID: 34428241 (View on PubMed)

Other Identifiers

EG0168

Identifier Type: -

Identifier Source: org_study_id