Accelerating adoption of patient-centered cervical cancer screening and treatment linkage in Kenya: protocol for a cluster randomized effectiveness-implementation hybrid trial

Abstract

Cervical Cancer (CC) is the leading cause of cancer-related mortality among women in Kenya. Despite effective screening and treatment methods, substantial gaps persist across the CC cascade, with low screening coverage and poor linkage to triage and treatment. These gaps reflect multi-level implementation barriers at the patient, provider, and health system levels. Effective and feasible strategies are needed to improve delivery of guideline-recommended CC services within routine primary care. The DADA LINK study is a cluster randomized controlled trial evaluating implementation and effectiveness outcomes (type 2 hybrid) across 20 government primary healthcare facilities in Nairobi County, Kenya. Clinics are randomized 1:1 to receive either the DADA LINK care integration package or standard of care. The DADA LINK package integrates human papillomavirus (HPV) self-testing and patient support (technical assistance at clinics and an mHealth application, WEMA) to facilitate result notification and linkage to triage and treatment for women with positive HPV or visual inspection with acetic acid (VIA). Control clinics continue routine cervical cancer screening, referral, and treatment practices according to Kenyan National Guidelines. We will enroll 1,980 women aged 25–49 years presenting for care at Nairobi County clinics. Exclusion criteria include pregnancy, ≤ 6 weeks postpartum status, or known cervical cancer. The primary implementation outcome is completion of screening via either HPV self-testing or VIA. The primary effectiveness outcome is linkage to triage (with VIA or biopsy) and/or treatment among women with positive screening results. Secondary outcomes will capture care cascade processes, including result communication to screen positive patients and form of triage/treatment received. Analyses account for clustering at the clinic level and include estimation of incremental program costs using activity-based micro-costing from the health system perspective. This trial evaluates a multi-strategy implementation package designed to strengthen cervical cancer screening and treatment linkage within routine primary care in Nairobi. Findings will inform scalability, sustainability, and policy decisions aimed at reducing cervical cancer burdens in Kenya and similar low-resource settings. ClinicalTrials.gov: NCT07050745. Registered on June 25, 2025. https://clinicaltrials.gov/study/NCT07050745 .