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Completed

NCT Number: NCT03397420

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

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Key information

Conditions

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

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbabane

Mbabane, Eswatini

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of HIV-positive children on ART virally suppressed

    Time frame: 18 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 the proportion with HIV RNA <1,000 copies/mL at 18 months after enrollment

  2. Proportion of HIV-positive on ART virally unsuppressed

    Time frame: 18 months after study enrollment.

    Proportion of HIV-positive children on ART with HIV RNA >1000 copies/mL 18 months after enrollment into the study.

Secondary outcomes

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

    Time frame: 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

  2. Factors associated with HIV viral suppression

    Time frame: 18 months after study enrollment

    Individual and family factors associated with viral suppression.

  3. Loss to follow-up

    Time frame: 18 months after study enrollment

    Loss to follow-up (not seen in clinical care >3 months)

  4. ART initiation

    Time frame: 18 months after study enrollment

    ART initiation in HIV-positive children not on ART at study entry

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

    Time frame: 18 months after study enrollment

    Acceptability of the FAM-CARE program to caregivers and health care provider as measured from responses on individual interviews using a structured questionnaire

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Ministry of Health, Swaziland
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Acronym: FAM-CARE

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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