CLUSTER RCT of A MID-LEVEL MANAGER INTERVENTION to PROMOTE IPT UPTAKE in UGANDA

ABSTRACT

Background: Despite longstanding guidelines endorsing isoniazid preventive therapy (IPT) for persons with HIV, uptake is low across sub-Saharan Africa. Mid-level health managers oversee IPT programs nationally;interventions aimed at this group have not been tested. Methods: We conducted a cluster randomized trial in Uganda among district-level health managers from 2017-2021. The unit of randomization was groups of 4-7 managers. Our intervention convened managers into mini-collaboratives facilitated by Ugandan TB/HIV experts and provided business leadership/management training, SMS platform access, and data feedback. The primary outcome was IPT initiation rates among adults with HIV in health facilities overseen by participants over 2 years (2019-2021). We compared incidence rates using cluster-level targeted minimum loss-based estimation. We conducted pre-specified analyses that excluded Q3-2019 to understand intervention effects independent of a national "100-day push" of IPT tied to a financial contingency during Q3-2019. Qualitative interviews were analyzed to ascertain mechanisms of intervention action. Results: Managers from 82/82 eligible districts (61% of Uganda's 135 districts) were enrolled and randomized 43 districts to intervention, 39 to control. After one year, in 5-point-Likert quantitative surveys, intervention-group managers demonstrated greater increases in familiarity with IPT (by +0.47 points (95%CI0.14-0.80)) and knowledge of IPT efficacy (+0.59 points (95%CI0.06-1.12)) as compared to control. Intervention-group managers reported improved within-district communication and inter-district collaboration and feeling empowered to better manage frontline providers, in contrast to control, in qualitative interviews. Over two years, the IPT initiation rate was 0.74 vs. 0.65 starts/person-year in intervention vs control incidence rate ratio (IRR)=1.14 (95%CI0.88-1.46;p=0.16). Excluding Q3-2019, IPT initiation was higher in intervention vs control 0.32 vs. 0.25 starts/person-year (IRR=1.27, 95%CI1.00-1.61, p=0.03;Figure). Conclusion: Though overall IPT initiation rates were not significantly higher with the mid-level manager intervention in this cluster randomized trial, rates were significantly higher compared to control when excluding the massive MoH-led "100-day IPT push" in both arms. The higher rates were sustained during the COVID-19 pandemic, suggesting benefits of targeted leadership and management training for mid-level health managers.