Trial Title:
Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal
NCT ID:
NCT05544084
Condition:
Cervical Cancer
Behavior
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention 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.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigator Approach
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.
Arm group label:
Adapted Patient Navigation Program
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.
Criteria for 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.
Gender:
All
Gender based:
Yes
Gender 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:
25 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Cheikh Anta Diop, Institute of Health and Development
Address:
City:
Dakar
Country:
Senegal
Status:
Recruiting
Contact:
Last name:
Adama Faye, MD, MPH, PhD
Phone:
221 77 324 63 36
Email:
adama.faye@ucad.edu.sn
Start date:
August 1, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
University of Illinois at Chicago
Agency class:
Other
Source:
University of Illinois at Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544084
