Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
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|ClinicalTrials.gov Identifier: NCT03540069|
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : June 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Behavior||Behavioral: Care Group Cervical Cancer Screening Education Curriculum||Not Applicable|
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
- investigating the access barriers and determinants of initial uptake and
- developing and adapting a peer education health promotion intervention to diverse and dynamic contexts to achieve sustained utilization.
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 Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake in aim 1,
- the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-management behavior of women in aim 2, and
- the Dynamic Sustainability Framework to evaluate the initial uptake and sustained utilization of the health service in aim 3.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||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 we 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).|
|Masking:||None (Open Label)|
|Official Title:||Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal|
|Actual Study Start Date :||October 3, 2018|
|Actual Primary Completion Date :||December 15, 2021|
|Actual Study Completion Date :||December 15, 2021|
Experimental: Cervical Cancer Screening Education
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
a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.
No Intervention: Control
No educational program is implemented for each cluster prior to crossover to intervention.
- Change in the number of women screened for the first time, age stratified [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of women who are screened for cervical cancer
- Change in the number of women and men recommending the service [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of women and men recommending that women of screening age get cervical cancer screening
- Change in the knowledge of cervical cancer [ Time Frame: measured at baseline and every 6 months through 35 months. ]Composite of Knowledge of cervical cancer score from the quantitative survey
- Change in the number of women being re-screened, age stratified [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of women being re-screened at 2 years per regional policy
- Change in the number of individuals directly receiving intervention [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of individuals communities directly receiving intervention
- Change in the number of households directly receiving intervention [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of households directly receiving intervention
- Change in the number communities directly receiving intervention [ Time Frame: measured at baseline and every 6 months through 35 months. ]Number of communities directly receiving intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540069
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche|
|Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & Institute of Health and Development|
|Principal Investigator:||Jon A Dykens, MD, MPH||University of Illinois at Chicago|