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Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal

Primary Purpose

Cervical Cancer, Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Patient Navigator Approach
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

25 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Cheikh Anta Diop, Institute of Health and DevelopmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adapted Patient Navigation Program

Control

Arm Description

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.

Standard of care

Outcomes

Primary Outcome Measures

Change in the number of women screened for the first time, age stratified uptake
Change in the number of women reporting cervical cancer screening uptake, age stratified

Secondary Outcome Measures

Change in time to treatment
Change in the time from diagnosis of a positive cervical cancer screen to treatment for dysplasia, age stratified
Change in perceived stigma of cervical cancer as the fault of the individual
Change in the number of women and men stating that if a woman gets cervical cancer it is probably their own fault, age stratified
Change in decision to get cervical cancer screen
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
Change in awareness of cervical cancer
Change in the number of women and men stating awareness of cervical cancer, age stratified"
Change in knowledge of need for screen despite symptoms
Change in the number of women and men stating awareness of the necessity for cervical cancer screening despite having no symptoms, age stratified
Change in spouse communication about cervical cancer screening
Perception of men and women of open communication with spouse regarding healthy approach to cervical cancer screening for women.

Full Information

First Posted
September 12, 2022
Last Updated
August 22, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05544084
Brief Title
Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal
Official Title
Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 there. Investigators will apply the Dynamic Adaptation Process1 (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework1 to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts in Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes. By studying the process of adaptation of a patient navigation program in a low- and middle-income country (LMIC), investigators will build new knowledge while addressing an important public health issue. Our project demonstrates innovation by advancing both adaptation and implementation process knowledge of an evidence-based patient navigation intervention in various contexts within a LMIC with a particular focus on how the adaptation responds to cancer-related stigma, misinformation, and women's autonomy in healthcare decision-making. Investigators will build knowledge through local learning which will further our long-term goal to inform the national cervical cancer prevention and control programs in two areas of Senegal and other similar LMICs.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Behavior

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Conduct an effectiveness-implementation hybrid type 1 stepped-wedge randomized pragmatic trial of the adapted patient navigation program across Kedougou and Dakar, Senegal.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
901 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adapted Patient Navigation Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigator Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of women screened for the first time, age stratified uptake
Description
Change in the number of women reporting cervical cancer screening uptake, age stratified
Time Frame
Baseline and then every 12 months through 36 months
Secondary Outcome Measure Information:
Title
Change in time to treatment
Description
Change in the time from diagnosis of a positive cervical cancer screen to treatment for dysplasia, age stratified
Time Frame
Baseline and then every 12 months through 36 months
Title
Change in perceived stigma of cervical cancer as the fault of the individual
Description
Change in the number of women and men stating that if a woman gets cervical cancer it is probably their own fault, age stratified
Time Frame
Baseline and then every 12 months through 36 months
Title
Change in decision to get cervical cancer screen
Description
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
Time Frame
Baseline and then every 12 months through 36 months
Title
Change in awareness of cervical cancer
Description
Change in the number of women and men stating awareness of cervical cancer, age stratified"
Time Frame
Baseline and then every 12 months through 36 months
Title
Change in knowledge of need for screen despite symptoms
Description
Change in the number of women and men stating awareness of the necessity for cervical cancer screening despite having no symptoms, age stratified
Time Frame
Baseline and then every 12 months through 36 months
Title
Change in spouse communication about cervical cancer screening
Description
Perception of men and women of open communication with spouse regarding healthy approach to cervical cancer screening for women.
Time Frame
Baseline and then every 12 months through 36 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
No exclusions will be made on the basis of gender for the baseline or longitudinal individual surveys or focus groups. However, focus groups will be split by gender indication (e.g., women-only focus group)
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon A Dyken, MD, MPH
Phone
573-355-0452
Email
jdykens@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon A Dykens, MD, MPH
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cheikh Anta Diop, Institute of Health and Development
City
Dakar
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adama Faye, MD, MPH, PhD
Phone
221 77 324 63 36
Email
adama.faye@ucad.edu.sn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share all IPD that underlie results in a publication
IPD Sharing Time Frame
Upon completion of the study. The materials will be available indefinitely.
Citations:
PubMed Identifier
32343755
Citation
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.
Results Reference
background
PubMed Identifier
28184171
Citation
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.
Results Reference
background
PubMed Identifier
31037032
Citation
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.
Results Reference
background

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Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal

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