The Impact of the Common Elements Treatment Approach on HIV Treatment Outcomes Among Women Experiencing Intimate Partner Violence in South Africa: A Randomized Trial

INTRODUCTION: In South Africa, which has the world's highest prevalence of HIV, intimate partner violence (IPV) and common mental health conditions are barriers to retention in HIV treatment and achieving viral suppression. The Common Elements Treatment Approach (CETA), a cognitive-behavioural-therapy-based intervention designed for lay healthcare worker delivery, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. We conducted a randomized control trial to evaluate the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa. METHODS: This was a single-blind trial conducted among women living with HIV on antiretroviral therapy (ART) who experienced sexual and/or physical IPV in the last 12 months and had either an unsuppressed viral load or were at risk for poor medication adherence in the past year (e.g. defaulted on treatment, late or missed clinic visit). Women were randomized 1:1 to receive either 8-12 CETA counselling sessions or weekly safety text messages. The primary outcome was viral suppression (≤50 copies/mL) (which requires retention) at 12 months after baseline, which was evaluated using routinely collected medical records. A linear regression model was estimated to calculate risk differences and 95% confidence intervals (CI). RESULTS: Participants were enrolled from 11 November 2021 to 19 July 2023, with 202 women randomized to CETA and 197 randomized to the control arm. Median age was 41.0 years (interquartile range [IQR]: 34.0, 47.0) with a median time on ART of 8.2 years (IQR: 4.3, 12.5). Receiving CETA was associated with a 1-percentage point (95% CI: -0.11, 0.09) decrease in retention and viral suppression compared to the control. When restricted to individuals who completed CETA (N = 144) compared to all controls, we observed a 7-percentage point (95% CI: -0.03, 0.18) increase in retention and viral suppression. CONCLUSIONS: Our estimates suggest overall there was no meaningful difference in retention and viral suppression at 12 months between individuals who received CETA compared to individuals who received the active safety control. Future work should seek to determine if CETA can be effective among those who complete the intervention.