A mid-level health manager intervention to promote uptake of isoniazid preventive therapy among people with HIV in Uganda: a cluster randomised trial

Defining and estimating effects in cluster randomized trials: A methods comparison

“…These real-world complexities reflect how CRTs are pragmatic and often need to respond to exogenous factors influencing both study interventions and outcomes. These secular events may entail modifications to the study design, follow-up period, primary endpoint, and statistical analysis plan; see, for example, Kakande et al 63 As previously discussed, adjustment for C-section in PTBi attenuated estimates of the intervention effect, especially at the cluster-level. It is possible that the intervention impacted who and where women received C-sections-thus violating the exclusion restriction in the causal model (Equation 1).…”

“…These real-world complexities reflect how CRTs are pragmatic and often need to respond to exogenous factors influencing both study interventions and outcomes. These secular events may entail modifications to the study design, follow-up period, primary endpoint, and statistical analysis plan; see, for example, Kakande et al 63 …”

Geographical, social, and political contexts of tuberculosis control and intervention, as reported by mid-level health managers in Uganda: ‘The activity around town’

“…To scale up the provision of IPT among PLHIV in the context of Uganda’s decentralized healthcare system, DHOs and their teams – the policy-implementation link between the Ministry of Health (MoH) and local community clinics – have needed strengthening. The SEARCH-IPT trial was designed to address underlying impediments to IPT uptake at the district level by spreading knowledge and data about IPT amongst DHOs and their teams by adapting messaging around prescribing additional pills to PLHIV who might object to an already challenging pill burden and by promoting accountability between DHOs and frontline workers despite geographic and infrastructural challenges ( Kakande et al, 2022 ).…”

“…In 2019, while the SEARCH-IPT trial was ongoing, as part of a requirement for continued support by PEPFAR (United States President’s Emergency Plan for AIDS Relief) Uganda launched a 100-day national IPT push ( Kiggundu, 2019 ). The rollout of IPT during the 100-day push was about equal in SEARCH-IPT trial control and intervention districts, but the trial intervention districts showed greater sustainability in IPT provisioning after the 100-day push ended ( Kakande et al, 2022 ). The following year, the trial was also affected by the nationwide COVID-19 lockdown of 2020, but higher rates of IPT initiation continued in the intervention groups ( Kakande et al, 2022 ).…”

“…The rollout of IPT during the 100-day push was about equal in SEARCH-IPT trial control and intervention districts, but the trial intervention districts showed greater sustainability in IPT provisioning after the 100-day push ended ( Kakande et al, 2022 ). The following year, the trial was also affected by the nationwide COVID-19 lockdown of 2020, but higher rates of IPT initiation continued in the intervention groups ( Kakande et al, 2022 ).…”