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

HIV Infections Clinical Trial

— FAM-CARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397420
• Other study ID #: EG0168
• Status: Completed
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: January 2020
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: July 30, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity

Intervention

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

Locations

Country	Name	City	State
Swaziland	Mbabane	Mbabane

Sponsors (3)

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

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	Factors associated with HIV viral suppression	Individual and family factors associated with viral suppression.	18 months after study enrollment
Secondary	Loss to follow-up	Loss to follow-up (not seen in clinical care >3 months)	18 months after study enrollment
Secondary	ART initiation	ART initiation in HIV-positive children not on ART at study entry	18 months after study enrollment
Secondary	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