Discussion
cervical cancer, HIV cascade, Cervical cancer
CERVICAL CANCER, CERVICAL CANCER, SECONDARY
In the primary intent-to-treat analysis, SAIA was not associated with a significant difference in visits where women were screened for cervical cancer in SAIA versus control clinics in the last quarter of the trial. Because the COVID-19 pandemic and healthcare worker strike impacted routine clinic operations in SAIA and control clinics, the pre-specified primary analysis may not be the best reflection of SAIA’s impact in this trial. When results were aggregated across 18 months, there is preliminary evidence that SAIA was associated with a nearly twofold increase in the proportion of visits with cervical cancer screening compared to controls, offering preliminary evidence.Integrating cervical cancer screening into FP clinics is a promising implementation strategy, particularly in low-and middle-income countries (LMICs), which can lower the burden on clients for additional visits and could increase the efficiency of resources being used [While the integration of services is one promising implementation strategy for increasing cervical cancer screening, other implementation strategies have also been evaluated. A scoping review in 2020 mapped different implementation strategies to improve cervical cancer screening in sub-Saharan Africa [To date, SAIA has been tested in other care cascades including preventing-mother-to-child transmission (PMTCT) in Kenya, Mozambique, and Cote d’Ivoire, HIV counseling and testing in FP clinics in Kenya, mental health in Mozambique, and the pediatric HIV cascade in Kenya. When used to improve the PMTCT cascade, SAIA was associated with improvements in antiretroviral coverage and the proportion of HIV-exposed infants screened for HIV in pre-specified sub-group analyses, though these associations were not statistically significant. HIV testing in antenatal clinics was not different in clinics implementing SAIA compared to usual procedures [In this present study when SAIA was tested to improve cervical cancer screening, a number of unique factors contributed to the lack of significant effect of the primary analysis. This study occurred concomitantly with the go-slow and strike and the COVID-19 pandemic, both of which unexpectedly and profoundly disrupted healthcare delivery across Mombasa. One SAIA clinic closed in month 2 of the trial. In other clinics, the pandemic restrictions and healthcare worker strike disrupted operations. This may explain why less than half of the proposed micro-interventions were implemented fully. Cervical cancer screening declined sharply in both SAIA and control clinics during the strike, highlighting the impact of healthcare disruptions on necessary preventative care. The primary analysis was scheduled for the end of the trial period, to allow time for SAIA’s effect to have the greatest impact over the 18-month study period, but this coincided with the end of the months-long healthcare worker go-slow and strike. Our experience with this trial and previously with HIV counseling and testing in FP clinics highlighted that SAIA’s effects were observed soon after the intervention and generally persisted over time with the exception of the major contextual impacts detailed previously. In this context, we propose that future SAIA trials should consider including data from the full implementation period in their primary analyses.This study had several strengths. First, the cluster randomized trial design rigorously tested SAIA in the cervical cancer screening care cascade. Second, this research included a collection of details about specific micro-interventions that clinics proposed and implemented. Granular data on the micro-interventions selected, how well they were implemented, and the effect on cervical cancer screening provided a better understanding of how SAIA worked. Finally, the quality control procedures employed in this study helped to optimize the capture and quality of the programmatic data examined to identify study outcomes.A few limitations are important to note. These data present the prevalence of visits where cervical cancer screening was performed rather than the proportion of eligible women who were screened. To measure the proportion of eligible women screened, there would need to be a robust system for following individual FP clients over time. This was not possible with the paper registers in use at the time of the study. Despite this limitation, a post hoc secondary analysis of data for 18 months of implementation was able to detect an overall effect of the SAIA implementation strategy on the proportion of visits at which cervical cancer screening was performed. This secondary analysis had > 99% power in a post hoc power calculation. Next, despite randomization, the relatively small number of clinics in the trial contributed to baseline differences between the SAIA arm and the control arms, particularly in provider training for cervical cancer screening. This limitation was mitigated by performing analyses that adjusted for baseline differences [