Clinical trial NCT03397420: Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Ministry of Health, Swaziland
First posted: 2018-01-12
Enrollment: 742
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of HIV-positive children on ART virally suppressed
timeFrame: 18 months after study enrollment.
measure: Proportion of HIV-positive on ART virally unsuppressed
timeFrame: 18 months after study enrollment.
Secondary outcomes:
measure: Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment
timeFrame: 6 and 12 months after study enrollment
measure: Factors associated with HIV viral suppression
timeFrame: 18 months after study enrollment
measure: Loss to follow-up
timeFrame: 18 months after study enrollment
measure: ART initiation
timeFrame: 18 months after study enrollment
measure: Acceptability of the FAM-CARE program based on individual interview responses
timeFrame: 18 months after study enrollment
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: Mbabane
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Caspian Chouraya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Swaziland
name: Nobuble Mthethwa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Lynne Mofenson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.