Effectiveness of a community-based intervention (Konga model) to address factors contributing to low viral load suppression among children living with HIV in Tanzania: a preliminary, cluster, randomized clinical trial report

Abstract

AbstractBackgroundDespite effective antiretroviral therapy (ART) coverage in other groups living with human immunodeficiency virus (HIV) in Tanzania, virologic suppression among HIV-positive children receiving ART remains unacceptably low. This study evaluated the effectiveness of a community-based intervention (Konga model) in addressing the factor contributing to low viral load suppression among children living with HIV in the Simiyu region, Tanzania.MethodsThis study used a parallel cluster randomized trial. The cluster was only eligible if the health facility provided HIV care and treatment. All eligible resident children aged 2‒14 years who attended the cluster with a viral load > 1,000 cells/mm were enrolled. The intervention included three distinct activities: adherence counseling, psychosocial support, and co-morbidity screening such as tuberculosis. The evaluation was based on patient-centered viral load outcomes measured at baseline and 6 months later. Using a pre- and post-test design, we compared the means of participants in the intervention and control groups. We performed an analysis of covariance. The effect of a Konga was calculated using omega-squared. We used F-tests, with their corresponding p-values, as measures of improvement.ResultsWe randomly assigned 45 clusters to the treatment (15) and control (30) groups. We enrolled 82 children with amedian age of 8.8 years(interquartile range(IQR);5.5–11.2), and a baseline median viral load of 13,150 cells/mm (interquartile range (IQR);3600–59,200). After the study, both children in each group had good adherence, with children in the treatment group scoring slightly higher than those in the control group, 40 (97.56%) versus 31(75%61), respectively. At the end of the study, the difference in viral load suppression between the two groups was significant. The median viral load suppression at the end of the study was 50 cells/mm [IQR, (20–125)]. After adjusting for the viral load before the intervention, the effect size of the Konga intervention explained 4% (95% confidence interval [0%, 14.1%]) of the viral load variation at the end of the intervention.ConclusionThe Konga model demonstrated significant positive effects that improved viral load suppression. We recommend implementing the Konga model trial in other regions to improve the consistency of results.