Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal

NCT03540069 | Completed

• 2 other identifiers: 2016-09471K01TW010494-01
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

Brief Summary

This research project will investigate the determinants of cervical cancer screening uptake and sustained utilization in this region and develop and evaluate a context-specific peer education behavioral intervention to improve uptake. Research supports the effectiveness of peer education in increasing cancer screening rates but, currently, no cervical cancer screening peer education program specific to rural Senegal exists. To inform the participatory development of this program, the investigators will assess barriers and facilitators of screening at multiple levels: individuals (women aged 30 to 59), households (family or principle social unit of at-risk women), and the community (immediate village or neighborhood with common amenities of at-risk women). We hypothesize that a peer education program that adapts to changing contexts over time and is targeted at a multi-level audience will result in early, widespread uptake and sustained use of the VIA cervical cancer screening program. Study findings will inform programmatic planning in Kedougou and the peer education curriculum we develop can serve as a template for maximizing early impact of new cervical cancer screening services implemented in other areas of rural Senegal. Our long-term goal is to inform national-level policy to guide the implementation of cervical cancer screening programs in other rural Senegal regions.

Conditions

Cervical Cancer; Behavior

Outcome Measures

Primary Outcomes (1)

• Change in the number of women screened for the first time, age stratified

  Number of women who are screened for cervical cancer

  measured at baseline and every 6 months through 35 months.

Secondary Outcomes (6)

• Change in the number of women and men recommending the service

  measured at baseline and every 6 months through 35 months.

• Change in the knowledge of cervical cancer

  measured at baseline and every 6 months through 35 months.

• Change in the number of women being re-screened, age stratified

  measured at baseline and every 6 months through 35 months.

• Change in the number of individuals directly receiving intervention

  measured at baseline and every 6 months through 35 months.

• Change in the number of households directly receiving intervention

  measured at baseline and every 6 months through 35 months.

Study Arms (2)

Cervical Cancer Screening Education

EXPERIMENTAL

Context-specific multi-level peer education cervical cancer screening education curriculum is implemented by Care Groups. This is conducted through a cluster-randomized stepped wedge study. Cluster 1 (randomly selected) crosses to the intervention arm at Period 2, Cluster 2 (randomly selected) crosses over to the intervention arm at Period 3, and so on. By the end of the study, all clusters will cross over to the intervention arm (one-way), though in random order. At the end of the final time period, the outcome of interest is compared between the intervention and control periods within each cluster. Differences in service utilization and recommendation will be compared, whereby clusters serve as their own controls as they cross over from the control to intervention group.

Behavioral: Care Group Cervical Cancer Screening Education Curriculum

Control

NO INTERVENTION

No educational program is implemented for each cluster prior to crossover to intervention.

Interventions

Care Group Cervical Cancer Screening Education Curriculum BEHAVIORAL

a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.

Cervical Cancer Screening Education

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: No exclusions will be made on the basis of gender for the baseline or longitudinal individual surveys. Men will be excluded from the focus groups (these will be women only) that gather information about the educational curriculum.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female Senegal citizen between the ages of 30 and 59,
• Resident in Kedougou Region,
• eligible to seek cervical cancer prevention services at a designated intervention or control health center in the Kedougou Region, Senegal,
• willing to participate in survey assessments; 5) able to give informed consent.
• male Senegal citizen between the ages of 30 and 59,
• Resident in Kedougou Region,
• living in a household with at least one woman eligible to seek cervical cancer prevention services at a designated intervention or control health center in the Kedougou Region, Senegal,
• willing to participate in survey assessments;
• able to give informed consent.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche

Dakar, Senegal

Location

Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & Institute of Health and Development

Dakar, Senegal

Location

Related Publications (1)

• 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

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

Study Design

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

Model Details: a cluster-randomized stepped wedge study across three representative clusters (each containing a district center and two rural sites) in the Kedougou region. For each aim we will collect data at baseline and at 6-month intervals in each cluster (data collection intervals coincide with the initiation of the intervention in a new cluster).

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 30, 2018
• Study Start: October 3, 2018
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

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

US (1); SE (2)