Randomised trial of the impact of HIV-TB integration quality improvement on mortality in PHC clinics in SA

28 February 2022

The first randomised trial to test a scalable HIV-TB integration strategy using quality improvement (QI) methods assessed the impact of QI for HIV-TB integration on mortality in primary healthcare (PHC) clinics in South Africa. The CAPRISA-led study showed that improvements to health systems operational processes in real-world settings remains a challenge.

The study, Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial, published in the Lancet journal eClinicalMedicine, highlighted the high level of health systems planning and organization required for delivery of complex QI supported HIV-TB integration interventions.

An open-label cluster randomized controlled study was conducted between 2016 and 2018 in 40 rural clinics in South Africa. Overall, 21 379 participants were enrolled between December 2016 and December 2018 in intervention and control arm clinics: 1329 and 841 HIV-TB co-infected (10·2%); 10 799 and 6 611 people living with Human Immunodeficiency Virus (HIV)/ acquired immunodeficiency syndrome (AIDS) (PLWHA) only (81·4%); 1 131 and 668 patients with TB only (8·4%), respectively.

The analysis population consisted of patients newly diagnosed with (i) both TB and HIV (ii) HIV only (among patients previously treated for TB or those who never had TB before) and (iii) TB only (among patients already diagnosed with HIV or those who were never diagnosed with HIV) after QI implementation in the intervention arm, or enrolment in the control arm. 

Despite the intervention, high mortality rates among HIV-TB co-infected patients were found.  However, the study found the health system to be responsive to strategic implementation support, showing overall improvements in performance.

For further reading see: Naidoo K, et al. eClinicalMedicine 2022; 44:101298. doi: 10.1016/j.eclinm.2022.101298  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8850328/

Figure: Cluster-specific mortality rates in the intervention (I) and control (C) arm clinics among HIV-TB co-infected.

The colours gray and blue representing clusters in the intervention and control arms, respectively