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

NCT05544084 | Recruiting DMC

• 1 other identifier: R01CA258683
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Behavior

Outcome Measures

Primary Outcomes (1)

• Change in the number of women screened for the first time, age stratified uptake through self-report questionnaire and confirmed through record review

  Change in the number of women reporting cervical cancer screening uptake, age stratified

  Baseline and then every 12 months through 36 months

Secondary Outcomes (6)

• Change in time to treatment for dysplasia, age stratified, through record review

  Baseline and then every 12 months through 36 months

• Change in perceived stigma of cervical cancer as the fault of the individual, through questionnaire

  Baseline and then every 12 months through 36 months

• Change in decision to get cervical cancer screen, age stratified, through questionnaire

  Baseline and then every 12 months through 36 months

• Change in awareness of cervical cancer, age stratified, through questionnaire

  Baseline and then every 12 months through 36 months

• Change in knowledge of need for screen despite symptoms, age stratified, through questionnaire

  Baseline and then every 12 months through 36 months

Study Arms (2)

Adapted Patient Navigation Program

EXPERIMENTAL

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.

Behavioral: Patient Navigator Approach

Control

NO INTERVENTION

Standard of care

Interventions

Patient Navigator Approach BEHAVIORAL

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 barriers and community-level stigma associated with cancer within the Senegal context.

Adapted Patient Navigation Program

Eligibility Criteria

• Age: 25 Years - 69 Years
• Gender Eligibility Details: 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)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Cheikh Anta Diop, Institute of Health and Development

Dakar, Senegal

RECRUITING

Related Publications (3)

• 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.

  PMID: 32343755 BACKGROUND

• 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.

  PMID: 28184171 BACKGROUND

• 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.

  PMID: 31037032 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Behavior

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jon A Dykens, MD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon A Dykens, MD, MPH

CONTACT

573-355-0452; jdykens@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Family and Community Medicine

Model Details: Conduct an effectiveness-implementation hybrid type 1 stepped-wedge randomized pragmatic trial of the adapted patient navigation program across Kedougou and Dakar, Senegal.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 16, 2022
• Study Start: August 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon completion of the study. The materials will be available indefinitely.

Locations

SE (1)