An interventional study of Care Group Cervical Cancer Screening Education Curriculum in Cervical Cancer and Behavior, sponsored by University of Illinois at Chicago. Completed at 3 sites in 2 countries. Open to participants aged 30 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Screening
This research project will investigate the determinants of cervical cancer screening uptake and sustained utilization in this region and develop and evaluate a context-specific peer education behavioral intervention to improve uptake. Research supports the effectiveness of peer education in increasing cancer screening rates but, currently, no cervical cancer screening peer education program specific to rural Senegal exists. To inform the participatory development of this program, the investigators will assess barriers and facilitators of screening at multiple levels: individuals (women aged 30 to 59), households (family or principle social unit of at-risk women), and the community (immediate village or neighborhood with common amenities of at-risk women). We hypothesize that a peer education program that adapts to changing contexts over time and is targeted at a multi-level audience will result in early, widespread uptake and sustained use of the VIA cervical cancer screening program. Study findings will inform programmatic planning in Kedougou and the peer education curriculum we develop can serve as a template for maximizing early impact of new cervical cancer screening services implemented in other areas of rural Senegal. Our long-term goal is to inform national-level policy to guide the implementation of cervical cancer screening programs in other rural Senegal regions.
The goal of this study is to inform the sustainable implementation of cervical cancer screening services in low-resource areas of Senegal naïve to cancer screening programs by
Framework: Implementation Science is the study of how proven technical solutions are applicable to real world settings. The investigators will study how the implementation of VIA, as a proven intervention, can be optimized and how the screening service can best "fit" into the local context. Established complementary frameworks will guide our study. The investigators will apply
The investigators seek to understand the dynamic nature of the influential factors within the local context and the process by which the investigators can facilitate responsive adaptations to the intervention in order to reduce barriers, maximize early uptake, and sustain utilization.
Overview of Study Data Collection: To achieve all aims, the investigators will conduct a cluster-randomized stepped wedge study across three representative clusters (each containing a district center and two rural sites) in the Kedougou region. For each aim the investigators will collect data at baseline and at 6-month intervals in each cluster (data collection intervals coincide with the initiation of the intervention in a new cluster). In aim 1, the investigators will develop (through a participatory approach), pilot, and conduct surveys of eligible clients and household questionnaires as well as focus groups (FG) (women ages 30-44 and 45-59) and in-depth interviews of men (ages 30-59). For aim 2, the investigators will describe the development, piloting, implementation, and adaptation of an aim 1-informed context-specific multi-level peer education curriculum across clusters through the stepped wedge approach in the Kedougou region. The investigators will collect quantitative program reach data and qualitative process evaluation data at each time period. These data will be used to adapt the intervention over time. To achieve aim 3, the investigators will collect aggregated health service level utilization data and individual surveys.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 160 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women. Criteria for inclusion include:
Men. Criteria for inclusion include:
Exclusion Criteria:
Context-specific multi-level peer education cervical cancer screening education curriculum is implemented by Care Groups. This is conducted through a cluster-randomized stepped wedge study. Cluster 1 (randomly selected) crosses to the intervention arm at Period 2, Cluster 2 (randomly selected) crosses over to the intervention arm at Period 3, and so on. By the end of the study, all clusters will cross over to the intervention arm (one-way), though in random order. At the end of the final time period, the outcome of interest is compared between the intervention and control periods within each cluster. Differences in service utilization and recommendation will be compared, whereby clusters serve as their own controls as they cross over from the control to intervention group.
Behavioral: Care Group Cervical Cancer Screening Education Curriculum
No educational program is implemented for each cluster prior to crossover to intervention.
a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.
Change in the number of women screened for the first time, age stratified
Number of women who are screened for cervical cancer
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of women and men recommending the service
Number of women and men recommending that women of screening age get cervical cancer screening
Time frame: measured at baseline and every 6 months through 35 months.
Change in the knowledge of cervical cancer
Composite of Knowledge of cervical cancer score from the quantitative survey
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of women being re-screened, age stratified
Number of women being re-screened at 2 years per regional policy
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of individuals directly receiving intervention
Number of individuals communities directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of households directly receiving intervention
Number of households directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number communities directly receiving intervention
Number of communities directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will share all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago