Clinical trial NCT05544084: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Behavior
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 901
Sex: ALL
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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

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 Process (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework 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. The 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 the 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)

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 the 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.

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.

Primary outcomes:
measure: Change in the number of women screened for the first time, age stratified uptake through self-report questionnaire and confirmed through record review
timeFrame: Baseline and then every 12 months through 36 months
Secondary outcomes:
measure: Change in time to treatment for dysplasia, age stratified, through record review
timeFrame: Baseline and then every 12 months through 36 months
measure: Change in perceived stigma of cervical cancer as the fault of the individual, through questionnaire
timeFrame: Baseline and then every 12 months through 36 months
measure: Change in decision to get cervical cancer screen, age stratified, through questionnaire
timeFrame: Baseline and then every 12 months through 36 months
measure: Change in awareness of cervical cancer, age stratified, through questionnaire
timeFrame: Baseline and then every 12 months through 36 months
measure: Change in knowledge of need for screen despite symptoms, age stratified, through questionnaire
timeFrame: Baseline and then every 12 months through 36 months
measure: Change in spouse communication about cervical cancer screening, through questionnaire
timeFrame: Baseline and then every 12 months through 36 months
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: University of Cheikh Anta Diop, Institute of Health and Development
Study officials:
affiliation: University of Illinois at Chicago
name: Jon A Dykens, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.