- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544084
Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this project is to prevent unnecessary deaths due to cervical cancer in Senegal. This mixed methods research responds to identified intrapersonal- and community-level barriers to early cervical cancer screening uptake, follow-up, and treatment among women in Senegal. Investigators will apply the Dynamic Adaptation Process to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts of Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes.
Aim 1: Evaluate the adaptation process of the evidence-based Chinatown Patient Navigation Program utilizing the Dynamic Adaptation Process across rural and urban contexts in Kedougou and Dakar, Senegal. (n=6 clusters)
Aim 2: Conduct an effectiveness-implementation hybrid type 1 stepped-wedge randomized pragmatic trial of the adapted patient navigation program across Kedougou and Dakar, Senegal.
H1 - Participants who receive active navigation services will be more likely to get screened for cervical cancer (primary outcome) and obtain treatment more rapidly. (n=370 women) H2 - Participants who receive patient navigation services and their partners will experience or report fewer intrapersonal- and community-level barriers including cancer-related stigma (secondary outcomes) and lack of autonomy in healthcare decision-making. (n=740 women and men)
Aim 3: Evaluate the implementation outcomes9 (feasibility, acceptability, fidelity, penetrance, sustainability, and cost) of The Adapted Patient Navigation Program across multiple contexts in the Kedougou and Dakar regions, using mixed methods and guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework.(n=96 participants across 6 clusters)
In Aim 1 will adapt the evidence-based Chicago Chinatown Program into the urban and rural Senegal contexts. Investigators will accomplish the EXPLORATION PHASE of Aim 1 by first conducting a multilevel (system/ organization, provider, and client) assessment of stakeholder characteristics relevant to the context of three districts in rural Kedougou and three districts in urban Dakar, Senegal (randomly selected). Contextual assessment will be iterative, capturing data at each interval of the stepped wedge approach. This will continue to inform the iterative adaptation of the program. In the PREPARATION PHASE, investigators will delineate the core elements and adaptable features of the Chinatown Program and describe the iterative adaptation (guided and ad hoc), through a participatory approach, of The Adapted Program across Kedougou and Dakar, Senegal. Next, in the IMPLEMENTATION PHASE, Aim 2, investigators will conduct a stepped-wedge randomized pragmatic trial in three districts in the Kedougou Region and three districts in Dakar to evaluate the impact of The Adapted Program. In order to conduct this trial, investigators will deploy The Adapted Program and evaluate the impact of The Adapted Program on screening uptake and time to treatment initiation (for those with abnormal screening results) within the various contexts across clusters. Investigators will also explore the effect of The Adapted Program on intrapersonal- and community-level barriers. Finally, during the SUSTAINMENT PHASE Aim 3 investigators will evaluate the implementation outcomes of The Adapted Program within the context of these rural and urban districts. Investigators will evaluate the feasibility, acceptability, fidelity, penetrance, sustainability, and cost of The Adapted Program as each district prepares, rolls out, and sustains The Adapted Program in the Kedougou and Dakar regions.
Each of the six clusters completes all four Implementation steps (exploration, preparation, implementation, and sustainment), with extensive initial support from research team members during exploration, preparation, and implementation. Support decreases gradually as clusters gain the experience to sustain patient navigation activities. If successful, the health system will integrate patient navigation as a means to facilitate the uptake of cervical cancer services and manage patients along the cancer care continuum.Evaluation of the success of patient navigation is determined as follows:
For Aims 1 and 3, the Exploration, Preparation, Implementation, Sustainment (EPIS) framework guides our mixed methods analysis of success and contextual factors related to success.
For Aim 2, investigators assess outcomes four times using participants' self-report surveys and medical records.
At a time of major global health policy shifts, these results will provide strong evidence for patient navigation policy decisions in low-income countries and will advance implementation science.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jon A Dyken, MD, MPH
- Phone Number: 573-355-0452
- Email: jdykens@uic.edu
Study Locations
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Dakar, Senegal
- Recruiting
- University of Cheikh Anta Diop, Institute of Health and Development
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Contact:
- Adama Faye, MD, MPH, PhD
- Phone Number: 221 77 324 63 36
- Email: adama.faye@ucad.edu.sn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The inclusion criteria for samples a, b, & c are as follows:
1) Senegal citizen between the ages of 25 and 69, 2) willing to participate in survey assessments;
The additional criteria apply for both women and men for the follow samples:
Sample a: 3) an invited member of the study National Advisory Board or Regional Implementation Resource Teams as defined above; 4) able to read and write in French.
Sample b: 3) employed by the state at a study site health facility as a patient navigator, clinician (nurse, midwife) who treats and educates patients, or is a community health worker at the facility or community level (Bajenu Gox - women's health educator).
Sample c: Women: 3) a woman living with a male partner who also agrees to participate in the study, 4) eligible to seek cervical cancer prevention services at a designated health facility in Senegal. Men: 3) a man living in a household with at least one woman eligible to seek cervical cancer prevention services at a designated health facility in Senegal.
Exclusion Criteria:
- No additional exclusion criteria exist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Standard of care
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Experimental: Adapted Patient Navigation Program
Adaptation of a patient navigation approach to effect change in cervical cancer screening uptake in Kedougou and Dakar, Senegal.
Conduct a stepped-wedge randomized pragmatic trial in three districts in the Kedougou Region and three districts in Dakar to evaluate the impact of The Adapted Program.
In order to conduct this trial, investigators will deploy The Adapted Program and evaluate the impact of The Adapted Program on screening uptake and time to treatment initiation (for those with abnormal screening results) within the various contexts across clusters.
Investigators will also explore the effect of The Adapted Program on intrapersonal- and community-level barriers.
Finally, evaluate the implementation outcomes of The Adapted Program within the context of these rural and urban districts, whereby clusters serve as their own controls as they cross over from the control to intervention group.
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Patient navigators in collaboration with community health workers will work with women eligible for cervical cancer screening to overcome intrapersonal and community level barriers to screening in order to engage early with the health system for cervical cancer screening and follow-up of positive screens.
Their support can help patients get the cancer screenings and follow-up care they need, while addressing prevalent gender inequities and community-level stigma associated with cancer within the Senegal context.
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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 uptake
Time Frame: Baseline and then every 12 months through 36 months
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Change in the number of women reporting cervical cancer screening uptake, age stratified
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Baseline and then every 12 months through 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time to treatment
Time Frame: Baseline and then every 12 months through 36 months
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Change in the time from diagnosis of a positive cervical cancer screen to treatment for dysplasia, age stratified
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Baseline and then every 12 months through 36 months
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Change in perceived stigma of cervical cancer as the fault of the individual
Time Frame: Baseline and then every 12 months through 36 months
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Change in the number of women and men stating that if a woman gets cervical cancer it is probably their own fault, age stratified
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Baseline and then every 12 months through 36 months
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Change in decision to get cervical cancer screen
Time Frame: Baseline and then every 12 months through 36 months
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Change in the number of women and men stating that women are able to make their own decisions regarding getting screened for cervical cancer, age stratified
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Baseline and then every 12 months through 36 months
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Change in awareness of cervical cancer
Time Frame: Baseline and then every 12 months through 36 months
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Change in the number of women and men stating awareness of cervical cancer, age stratified"
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Baseline and then every 12 months through 36 months
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Change in knowledge of need for screen despite symptoms
Time Frame: Baseline and then every 12 months through 36 months
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Change in the number of women and men stating awareness of the necessity for cervical cancer screening despite having no symptoms, age stratified
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Baseline and then every 12 months through 36 months
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Change in spouse communication about cervical cancer screening
Time Frame: Baseline and then every 12 months through 36 months
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Perception of men and women of open communication with spouse regarding healthy approach to cervical cancer screening for women.
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Baseline and then every 12 months through 36 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jon A Dykens, MD, MPH, University of Illinois at Chicago
Publications and helpful links
General Publications
- Ongtengco N, Thiam H, Collins Z, De Jesus EL, Peterson CE, Wang T, Hendrix E, Ndiaye Y, Gueye B, Gassama O, Kasse AA, Faye A, Smith JS, Fitzgibbon M, Dykens JA. Role of gender in perspectives of discrimination, stigma, and attitudes relative to cervical cancer in rural Senegal. PLoS One. 2020 Apr 28;15(4):e0232291. doi: 10.1371/journal.pone.0232291. eCollection 2020.
- Dykens JA, Linn AM, Irwin T, Peters KE, Pyra M, Traore F, Toure Diarra M, Hasnain M, Wallner K, Linn P, Ndiaye Y. Implementing visual cervical cancer screening in Senegal: a cross-sectional study of risk factors and prevalence highlighting service utilization barriers. Int J Womens Health. 2017 Jan 27;9:59-67. doi: 10.2147/IJWH.S115454. eCollection 2017.
- Simon MA, Tom LS, Leung I, Wong E, Knightly EE, Vicencio DP, Yau A, Ortigara K, Dong X. The Chinatown Patient Navigation Program: Adaptation and Implementation of Breast and Cervical Cancer Patient Navigation in Chicago's Chinatown. Health Serv Insights. 2019 Apr 18;12:1178632919841376. doi: 10.1177/1178632919841376. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- R01CA258683 (U.S. NIH Grant/Contract)
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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