JMIR Publications

ABSTRACT

Background:

Kenyan women experience a high burden from breast and cervical cancers. Screening can result in earlier diagnosis which can reduce mortality but its uptake is extremely low. The proportion of women up to date with screenings within intervals recommended by guidelines is low implying that providers have limited opportunity to educate women to identify cancer symptoms, which can further facilitate early detection and diagnosis.

Objective:

Our goal is to test complementary strategies in community and clinic settings that can improve community–clinic linkages (C3Linkages) and address multilevel barriers. The main aim of this study is to conduct randomized trials to compare a community-clinic linkage program (C3Link program) with enhanced usual care. This study aims to i). conduct a cluster randomized trial to assess short-term (intervention phase) and longer-term impact (maintenance phase) of the C3Link package of strategies, ii). use a mixed-methods approach to assess multilevel implementation outcomes and iii). perform cost-effectiveness and return on investment analysis to support scale-up of effective approaches and strategies.

Methods:

We will adopt a pragmatic study design to systematically assess implementation strategies to increase breast and cervical cancer screenings and evaluate their sustainability in three counties: Machakos, Nakuru and Nyeri. Complementary strategies in community and clinic settings can improve community–clinic linkages and address multilevel barriers. We will use theory-informed multilevel strategies to create the Cancer Community–Clinic Linkage (C3Link) package of implementation strategies that include Community Health Worker (referred to as Community Health Promoter (CHP) in Kenya)-led strategies in the community and practice facilitation in the clinic setting. We will use implementation science methods to evaluate effectiveness (along with mediating outcomes such as knowledge, self-efficacy, positive peer and family support, accurate cancer risk assessment, care seeking behaviour, confidence in health care provider and screening processes), implementation outcomes, and cost-effectiveness of the C3Link program compared with the enhanced usual care.

Results:

This study was funded in July 2022, received Institutional Review Board approvals in November 2022 (United States) and June 2023 (Kenya). It was registered on ClinicalTrials.gov in September 2024. Enrolment began in September 2024 and was concluded in November 2024. Preliminary analyses will commence after the completion of the first year of intervention - the C3Link core activities.

Conclusions:

The C3Link Program is expected to yield better screening and follow-up outcomes than the control – enhanced usual care, but will require more resources. The predetermined sequential implementation strategies will allow us to determine incremental cost-effectiveness of each strategy in the sequence to guide policy. Clinical Trial: NCT06572774