- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540069
Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dakar, Senegal
- Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche
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Dakar, Senegal
- Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & Institute of Health and Development
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women. Criteria for inclusion include:
- female Senegal citizen between the ages of 30 and 59,
- Resident in Kedougou Region,
- eligible to seek cervical cancer prevention services at a designated intervention or control health center in the Kedougou Region, Senegal,
- willing to participate in survey assessments; 5) able to give informed consent.
Men. Criteria for inclusion include:
- male Senegal citizen between the ages of 30 and 59,
- Resident in Kedougou Region,
- living in a household with at least one woman eligible to seek cervical cancer prevention services at a designated intervention or control health center in the Kedougou Region, Senegal,
- willing to participate in survey assessments;
- able to give informed consent.
Exclusion Criteria:
- No additional exclusion criteria exist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.
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NO_INTERVENTION: Control
No educational program is implemented for each cluster prior to crossover to intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Number of women who are screened for cervical cancer
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measured at baseline and every 6 months through 35 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of women and men recommending the service
Time Frame: measured at baseline and every 6 months through 35 months.
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Number of women and men recommending that women of screening age get cervical cancer screening
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measured at baseline and every 6 months through 35 months.
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Change in the knowledge of cervical cancer
Time Frame: measured at baseline and every 6 months through 35 months.
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Composite of Knowledge of cervical cancer score from the quantitative survey
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measured at baseline and every 6 months through 35 months.
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Change in the number of women being re-screened, age stratified
Time Frame: measured at baseline and every 6 months through 35 months.
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Number of women being re-screened at 2 years per regional policy
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measured at baseline and every 6 months through 35 months.
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Change in the number of individuals directly receiving intervention
Time Frame: measured at baseline and every 6 months through 35 months.
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Number of individuals communities directly receiving intervention
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measured at baseline and every 6 months through 35 months.
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Change in the number of households directly receiving intervention
Time Frame: measured at baseline and every 6 months through 35 months.
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Number of households directly receiving intervention
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measured at baseline and every 6 months through 35 months.
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Change in the number communities directly receiving intervention
Time Frame: measured at baseline and every 6 months through 35 months.
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Number of communities directly receiving intervention
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measured at baseline and every 6 months through 35 months.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0947
- 1K01TW010494-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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