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Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03540069
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : June 14, 2022
Sponsor:
Collaborator:
Fogarty International Center of the National Institute of Health
Information provided by (Responsible Party):
Jon Andrew Dykens, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavior Behavioral: Care Group Cervical Cancer Screening Education Curriculum Not Applicable

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

  1. investigating the access barriers and determinants of initial uptake and
  2. 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

  1. the Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake in aim 1,
  2. the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-management behavior of women in aim 2, and
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
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)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   No exclusions will be made on the basis of gender for the baseline or longitudinal individual surveys. Men will be excluded from the focus groups (these will be women only) that gather information about the educational curriculum.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Senegal
Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche
Dakar, Senegal
Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & Institute of Health and Development
Dakar, Senegal
Sponsors and Collaborators
University of Illinois at Chicago
Fogarty International Center of the National Institute of Health
Investigators
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Principal Investigator: Jon A Dykens, MD, MPH University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Jon Andrew Dykens, University of Illinois at Chicago:
Study Protocol  [PDF] April 4, 2018

Publications:
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Responsible Party: Jon Andrew Dykens, Assistant Professor of Family Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03540069    
Other Study ID Numbers: 2016-0947
1K01TW010494-01 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon completion of the study. The materials will be available indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases