Abstract
Despite high prevalence of emotional and behavioral difficulties (EBDs) among adolescents living with HIV (ALHIV), there are limited randomized trials assessing the impact of interventions on these outcomes. We assessed the impact of two evidence-based interventions in a three-arm cluster randomized controlled trial (RCT) where nine clinics were randomized to one of three study arms: (1) Usual Care; (2) Group-Cognitive Behavioral Therapy (G-CBT) + Usual Care; and (3) Multiple Family groups (MFG) + Usual Care. We utilized mixed effects models to assess the effect of the intervention on EBDs. While the main effect of the intervention was not significant, χ2(2) = 0.43, p = 0.806, the main effects for time χ2(2) = 32.47, p < 0.001, and intervention-time interaction, χ2 (2) = 59.59, p < 0.001, were statistically significant, suggesting reduction in the EBDs across the groups overtime. Pairwise comparisons showed that in the G-CBT group, EBDs reduced at three months [contrast = -7.59 (CI: -8.20 - -6.99), <0.001] and 6-months [contrast = -8.11 (CI: -12.64 - -3.57), <0.001] compared to baseline. No statistically significant pairwise comparisons across time were observed in the control group, which confirmed that the significant group-by-time interactions were driven by our intervention effects. Findings that G-CBT improved EBDs in this pilot trial highlight the potential efficacy of this intervention in addressing EBDs among ALHIV. However, further studies are warranted to investigate prolonged exposure to MFG as well as combination of MFG and G-CBT to understand the nuances that will ultimately inform the development of tailored effective interventions for addressing EBDs in this vulnerable population.