'There are no more secrets': acceptability of a family-centered model of care for HIV positive children in Eswatini.

BACKGROUND: HIV-positive children have lagged adults on retention in HIV care and viral suppression. To address this gap, Eswatini's Ministry of Health started a pilot family-centered HIV care model (FCCM) targeting HIV-positive children under 20 years old and their families. METHODS: We conducted semi-structured in-depth interviews with 25 caregivers and 17 healthcare workers (HCWs) to assess acceptability of FCCM in four pilot FCCM health facilities in Hhohho region of Eswatini. Thematic analysis with inductive and deductive codes was used to identify salient themes. RESULTS: Caregivers and HCWs reported FCCM benefits including strengthening the family bond, encouragement for family members to disclose their HIV status and supporting each other in taking antiretroviral drugs. Caregivers reported that they spent fewer days in clinic, experienced shorter waiting times, and received better counseling services in FCCM compared to the standard-of-care services. FCCM implementation challenges included difficulty for families to attend clinic visits together (e.g., due to scheduling conflicts with weekend Teen Support Club meetings and weekday FCCM appointments). Both HCWs and caregivers mentioned difficulty in sharing sensitive health information in the presence of other family members. HCWs also had challenges with supporting caregivers to disclose HIV status to children and managing the larger group during clinic visits. CONCLUSIONS: FCCM for HIV-positive children was acceptable to both caregivers and HCWs, and they supported scaling-up FCCM implementation nationally. However, special considerations should be made to address the challenges experienced by participants in attending clinic visits together as a family in order to achieve the full benefits of FCCM for HIV positive children.

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.

INTRODUCTION: A family-centered care model (FCCM) providing family-based HIV services, rather than separate adult/pediatric services, has been proposed to increase pediatric retention and treatment adherence. MATERIALS AND METHODS: Eight health-care facilities in the Hhohho region of Eswatini were randomized to implement FCCM (n = 4) or continue standard-of-care (SOC) separate adult/pediatric clinics (n = 4). HIV-positive children and caregivers were enrolled; caregiver interview and child/caregiver chart abstraction were done at enrollment and every three months; pediatric viral load was evaluated at enrollment and every six months through 12 months. Because of study group differences in 12-month viral load data availability (89.4% FCCM and 72.0% SOC children had 12-month viral load), we used three separate analyses to evaluate the effects of FCCM on children's viral suppression (<1,000 copies/mL) and undetectable virus (<400 copies/mL) at 12 months. In the first analysis, all children with missing viral outcome data were excluded from the analysis (modified intent to treat, mITT). The second analysis used inverse probability of missingness weighted logistic regression to estimate the effect of FCCM on 12-month viral outcomes compared to SOC (weighted mITT). For the third approach, missing virologic outcome data were imputed as virologic failure (imputed ITT). We also examined factors associated with viral suppression at 12 months using multivariable logistic regression. RESULTS: We enrolled 379 HIV-positive children and 363 caregivers. Among all children at enrollment, viral suppression and undetectability was 78.4% and 73.9%, respectively, improving to 90.2% and 87.3% at 12 months. In mITT and weighted mITT analyses, there was no significant difference in children's 12-month viral suppression between FCCM and SOC groups (89.2% and 91.6%, respectively). Using imputed ITT, there was a modest increase in 12-month viral suppression in FCCM versus SOC children (79.7% and 69.8%, respectively, p = 0.051) and 12-month undetectability (78.7% and 65.7%, respectively, p = 0.015). Among the 255 children suppressed at enrollment, more FCCM versus SOC children (98.0% versus 95.3%) were suppressed at 12-months, but this was not statistically significant in mITT or weighted mITT analyses, with a marginally significant difference using imputed mITT analysis (p = 0.042). A higher proportion of children suppressed at enrollment had undetectable viral load at 12 months in FCCM versus SOC children (98.0% versus 92.5%), a statistically significant difference across analytical methods. Among the 61 children unsuppressed at enrollment, achieving suppression was higher among SOC versus FCCM children, but this difference was not statistically significant and included only 38 children; and there were no significant differences in detectable viral load at 12 months. There were no significant differences between study groups in retention or ART adherence at 12 months for children or caregivers. Factors associated with lack of viral suppression/detectability at 12 months included lack of viral suppression at enrollment and having a younger caregiver (age <25 years). CONCLUSIONS: FCCM in Eswatini was associated with a modest increase in viral suppression/undetectability at 12-months; 12-month retention and adherence did not differ by study group for children or caregivers. High levels of suppression and retention in both groups may have limited our ability to detect a difference. TRIAL REGISTRATION: NCT03397420; ClinicalTrials.gov.

Association of Antiretroviral Drug Regimen With Viral Suppression in HIV-positive Children on Antiretroviral Therapy in Eswatini.

BACKGROUND: Global pediatric treatment goals are for 90% of known children living with HIV to be on antiretroviral therapy (ART), with 90% having viral suppression. We used enrollment data from a study evaluating a family-centered HIV care program in Eswatini to describe the ART histories and virologic outcomes of enrolled children living with HIV and identify factors associated with viral suppression (<1000 RNA copies/mL) and undetectability (<400 RNA copies/mL). METHODS: Factors associated with viral suppression and undetectability were identified using Pearson χ for categorical variables and Wilcoxon rank sum tests for continuous variables. RESULTS: Three hundred seventy-seven children were enrolled, median age 8.5 years. Median age at HIV diagnosis was 2.1 years; at ART initiation, 2.6 years; and ART duration at enrollment, 4.1 years. Ninety-nine percent were receiving ART; 95.2% were on first-line ART and 4.8% on second-line ART. Most children (43.1%) were receiving nevirapine-based ART (median age 9.2 years), with 31.3% on lopinavir-ritonavir-based (median age 5.4 years) and 25.5%, efavirenz-based ART (median age 10.3 years). Viral suppression (<1000 copies/mL) was observed in 77.9% and undetectability (<400 copies/mL) in 73.5% of children. The only factor significantly associated with viral suppression was ART regimen, with 72.1% of children on nevirapine-based ART versus 86.7% on efavirenz-based ART virally suppressed. CONCLUSIONS: Although 99% of children enrolled in the study were receiving ART, viral suppression was observed in only 77.9%, with lowest rates among children receiving nevirapine-based ART. These findings highlight the critical importance of monitoring treatment regimen for optimizing treatment outcomes for pediatric HIV.