Effectiveness of couple education and counseling on knowledge, attitude and uptake of cervical cancer screening service among women of child bearing age in Southern Ethiopia: A cluster randomized trial protocol

BACKGROUND: Cervical cancer occurred nearly in 570 000 women and 311 000 women died from the disease worldwide in 2018. Of the new cases diagnosed globally in 2012, approximately 85% of the burden took place in low- and middle-income countries. Human Papilloma virus is the necessary cause for the development of cervical cancer and the majority of these infections resolves naturally but progress to precancerous lesions whenever there is persistence and delay in treatment. Majority of the cervical cancer cases, over 80% in sub-Saharan Africa including Ethiopia, have been detected at a late stage mainly due to poor early preventive measures. Therefore, utilization of early preventive measures could increase timely detection and treatment of precancerous changes and significantly reduce morbidity & mortality due to advanced disease. METHODS: In this interventional study we will randomly assign 16 clusters (kebeles) in to the intervention and the control arm using block randomization. The study will employ a cluster randomized controlled trial. Women are eligible to participate in this study when they satisfy certain eligibility criteria; being in the age range of 30–49 years, no history of hysterectomy, did not receive cervical cancer or pre-cancer treatment and non-pregnant. Home based couple education and counseling will be provided to the eligible participants within the intervention group, while the control group receives standard of care. Base line and end line surveys will be completed by interviewing 288 eligible women to evaluate the effect of couple education and counseling on the knowledge, attitude and cervical cancer screening uptake. Generally the intervention lasts for six months. The results of baseline & end line surveys will be compared between the groups to determine the effectiveness of the intervention. Blinding is not possible due to the clustering of the trial arms. DISCUSSION: Findings of the study will inform the regional or national scale up of the intervention modality to achieve the screening targets set by the Ethiopian government and world health organization. TRIAL REGISTRATION: PACTR, PACTR202108529472385. Registered on 05 August 2021, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=16037