RESUMO
BACKGROUND: Despite 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. METHODS: This 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 2â14 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. RESULTS: We 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. CONCLUSION: The 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.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Humanos , Criança , HIV , Fármacos Anti-HIV/uso terapêutico , Carga Viral , Tanzânia/epidemiologia , Infecções por HIV/diagnósticoRESUMO
Data were collected for a cluster-randomized clinical trial of the Konga community-based intervention using a validated questionnaire for children and caregivers. The raw and analyzed data include 82 participants with the following information: sociodemographic characteristics (caregiver's age, sex, and level of education, income, and caregiver's marital status) and clinical characteristics of the children (weight, CD4 cell count, and viral load at baseline and after 6 months of follow-up. The other data included in this dataset were weight, medication adherence, and opportunistic infections. Analysis of covariance (ANCOVA) was performed using the baseline VL. The outcome was viral load at the end of the intervention. Additionally, Omega squared (ω2) was used to calculate the effect size as an estimation of the strength of the intervention. These data will help researchers analyze data from similar studies and evaluate the effectiveness of community-based interventions for viral load suppression.
RESUMO
This study aims to test the effectiveness of a community-based intervention (Konga model) to improve viral-load suppression in children living with human immunodeficiency virus (HIV) and enrolled in care and treatment centers in Tanzania mainland. The study will be a cluster-randomized clinical trial study designed with both intervention and control arms. The study will involve 268 children with a viral load of >1000 copies/ml who are aged between 2 and 14 years. The children will be randomly allocated into the intervention and control arms. The intervention will include three distinct activities: adherence and retention counseling, psychosocial support, and comorbidity screening (i.e. tuberculosis). The outcome of the study will be assessment of the success of the intervention to increase medication adherence with the immediate result of reducing the viral load below 1000 copies/ml. Descriptive statistics will be used to calculate the mean, median, standard deviation, and interquartile range of continuous data. We will use frequencies and percentages to summarize categorical data. As for the primary outcome (proportion of HIV-infected children with viral suppression), we will compare the proportion of successful participants in the intervention and control arms. Proportions and tests for different proportions will be used as a measure of improvement. All statistical tests will be two-sided and P < 0.05 will be considered statistically significant.