Effectiveness of the Common Elements Treatment Approach (CETA) for mental and behavioral health outcomes among women struggling to remain adherent to HIV treatment and who have experienced intimate partner violence in South Africa: A randomised controlled trial.

Background: Rates of intimate partner violence (IPV) and HIV in South Africa are among the highest globally. IPV is associated with a range of adverse mental health and HIV outcomes. The Common Elements Treatment Approach (CETA) is a transdiagnostic, evidence-based intervention delivered by lay providers. Objective: To compare the effectiveness of CETA to active attention control in reducing IPV, depression, Post-Traumatic Stress Disorder (PTSD), and substance use among women at risk of poor HIV outcomes who have experienced IPV. Methods: Women living with HIV with an unsuppressed viral load or at risk for poor adherence and experienced past 12-month IPV were recruited from Johannesburg-area clinics and randomised 1:1 to CETA or control (SMS HIV appointment reminders plus safety checks and planning). The primary trial outcome was HIV retention and viral suppression, reported elsewhere. This paper reports secondary outcomes, evaluated at three and 12 months: IPV, depression, PTSD, and substance use. Findings: Participants were enrolled between November 11, 2021 to July 19, 2023 and randomised to CETA (N=202) or control (N=197). In the intent to treat analysis, the Cohen's d treatment effect for depression at three months was 0.24 (difference in mean change -3.1; 95% CI: -6.1, 0.1) and 0.48 at 12 months (-6.2; 95% CI: -9.5, -2.8). The PTSD treatment effect was 0.39 at three (-0.3; 95% CI: -0.5, -0.1) and 0.47 at 12 months (-0.3; 95% CI: -0.5, -0.2). Effect sizes were larger in a subgroup of participants with the top 50% of baseline symptom scores (depression: d=0.50, d=0.74; PTSD: d=0.58, d=0.94, at three and 12 months, respectively). There were no statistically significant differences in change for substance use or IPV. At baseline, only 12% of participants had past 3-month substance use and 32% had past 3-month or ongoing experiences of IPV, which made these outcomes challenging to evaluate. Conclusions: CETA was effective for reducing depression and PTSD including among high severity participants and at an extended follow-up. Future studies with increased power for substance use and IPV outcomes are warranted. Clinical implications: CETA is a recommended treatment for depression and PTSD among this population. Trial registration number: Clinicaltrials.gov NCT04242992 , registered January 27, 2020. Key Messages: