A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda

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PROJECT SUMMARY Cervical cancer (CC) is the leading cause of cancer-related deaths among women in Uganda, which has one of the world’s highest incidence rates. Evidence-based visual inspection with acetic acid (VIA) CC screening is free or low cost, yet ~ 5% of Ugandan women have ever screened for CC, and ~80% have advanced cancer when initiating care. Drawing on theories of network diffusion and social influence, and known patient-level, non-structural barriers and facilitators of CC screening, we developed the peer-led, 7-session group intervention Game Changers for Cervical Cancer Prevention (GC-CCP), a patient-level implementation strategy to increase CC screening. GC-CCP empowers women who have recently screened for CC to encourage screening among women in their social networks by disseminating CC knowledge, dispelling myths, and reducing CC stigma. An R21-funded pilot randomized controlled trial (RCT) revealed dramatic effects of increased CC screening among previously unscreened social network members (i.e., alters). These results, and our multidisciplinary team’s strong track record of successful collaboration, positions this application to make a strong impact on CC prevention and control in Uganda, which could be generalizable to other low to middle income country settings. We propose a hybrid type 1 RCT of GC-CCP to assess its effectiveness for increasing uptake of evidence-based VIA screening, and implementation and sustainability. The study design is guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) implementation science framework. Exploration: This phase consisted of the completed pilot and study site selection (two public, two private, one each in an urban and rural location). Preparation: In year 1, we will identify and remediate clinic- and provider-level barriers to ensure good access to and delivery of CC screening services. Implementation: At each site, 40 women screened for CC will enroll in the RCT as index participants (n=160 index) and be randomized to the intervention or wait-list control. Each index will recruit up to three (1st degree) alters (n~440 alters) at baseline who have not screened for CC; these index and alter participants will be followed up at months 6 and 12. At month 6, these alters will each recruit up to two (2nd degree) alters (n ~800 alters) for a phone interview. Sustainment: After enrolled index participants receive the intervention, each clinic will continue to implement GC-CCP (with clients not enrolled in the RCT) for an additional 2.5 years, with training and supervision tasks transferred to clinic staff. Using the RE-AIM framework, we will evaluate engagement in GC-CCP and CC advocacy (reach), alter CC screening (effectiveness), adoption into usual care, implementation outcomes (acceptability, fidelity, feasibility, cost), and maintenance. Innovative, sustainable implementation strategies such as GC-CCP are critical to increase demand for CC screening.