Though integrated therapies for human immunodeficiency virus-tuberculosis (HIV-TB) have reduced mortality, the “operational implementation of integrated services is challenging,” according to a study in EClinicalMedicine. The research, led by Kogieleum Naidoo, assessed the effect of a quality improvement (QI) program in primary healthcare (PHC) clinics in South Africa. Interestingly, the authors found that “HIV-TB integration supported by a QI intervention did not reduce mortality in HIV-TB co-infected patients.”

Naidoo and colleagues further concluded that “demonstrating mortality benefit from health systems process improvements in real-world operational settings remains challenging.”

Between 2016 and 2018, a total of 21,379 patients were enrolled from 40 rural clinics in South Africa, and randomized into 16 clusters to receive either QI, supported HIV-TB integration intervention, or standard of care (SoC). Among the cohort, 10.2% of patients had HIV-TB co-infection, 81.4% had HIV/acquired immunodeficiency syndrome (AIDS) only, and 8.4% patients had TB only.

According to the article, 6,529 (68.7%) patients in the intervention arm clinics and 4,074 (70.4%) in the control arm clinics were alive and in care at 12 months. The authors further reported that “568 (6.0%) and 321 (5.6%) had completed TB treatment, 1,078 (11.3%) and 694 (12.0%) were lost to follow-up, with 245 and 156 deaths occurring in intervention and control arms, respectively.” The overall mortality rate per 100 person-years was 4.5 (95% confidence interval [CI], 3.4–5.9) in the intervention arm compared to 3.8 (95% CI, 2.6–5.4) in the control arm (mortality rate ratio [MRR] = 1.19; 95% CI, 0.79–1.80). In patients with HIV-TB co-infection, the mortality rates were 10.1 (95% CI, 6.7–15.3) and 9.8 (95% CI, 5.0–18.9) per 100 person-years in the intervention and control arm clusters, respectively (MRR = 1.04; 95% CI, 0.51–2.10).

In closing, the authors remarked that “despite the study being potentially underpowered to demonstrate the effect size, integration interventions were implemented using existing facility staff and infrastructure reflecting the real-world context where most patients in similar settings access care, thereby improving generalizability and scalability of study findings.”