Clinical trial NCT03540069: Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
Official title: Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Behavior
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2018-05-30
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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).
Primary purpose: SCREENING

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.

Detailed description: The goal of this study is to inform the sustainable implementation of cervical cancer screening services in low-resource areas of Senegal naïve to cancer screening programs by

1. investigating the access barriers and determinants of initial uptake and
2. developing and adapting a peer education health promotion intervention to diverse and dynamic contexts to achieve sustained utilization.

Framework: Implementation Science is the study of how proven technical solutions are applicable to real world settings. The investigators will study how the implementation of VIA, as a proven intervention, can be optimized and how the screening service can best "fit" into the local context. Established complementary frameworks will guide our study. The investigators will apply

1. the Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake in aim 1,
2. the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-management behavior of women in aim 2, and
3. the Dynamic Sustainability Framework to evaluate the initial uptake and sustained utilization of the health service in aim 3.

The investigators seek to understand the dynamic nature of the influential factors within the local context and the process by which the investigators can facilitate responsive adaptations to the intervention in order to reduce barriers, maximize early uptake, and sustain utilization.

Overview of Study Data Collection: To achieve all aims, the investigators will conduct 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 the investigators 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). In aim 1, the investigators will develop (through a participatory approach), pilot, and conduct surveys of eligible clients and household questionnaires as well as focus groups (FG) (women ages 30-44 and 45-59) and in-depth interviews of men (ages 30-59). For aim 2, the investigators will describe the development, piloting, implementation, and adaptation of an aim 1-informed context-specific multi-level peer education curriculum across clusters through the stepped wedge approach in the Kedougou region. The investigators will collect quantitative program reach data and qualitative process evaluation data at each time period. These data will be used to adapt the intervention over time. To achieve aim 3, the investigators will collect aggregated health service level utilization data and individual surveys.

Eligibility criteria: Inclusion Criteria:

Women. Criteria for inclusion include:

* 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.

Men. Criteria for inclusion include:

* 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.

Exclusion Criteria:

* No additional exclusion criteria exist.

Primary outcomes:
measure: Change in the number of women screened for the first time, age stratified
timeFrame: measured at baseline and every 6 months through 35 months.
Secondary outcomes:
measure: Change in the number of women and men recommending the service
timeFrame: measured at baseline and every 6 months through 35 months.
measure: Change in the knowledge of cervical cancer
timeFrame: measured at baseline and every 6 months through 35 months.
measure: Change in the number of women being re-screened, age stratified
timeFrame: measured at baseline and every 6 months through 35 months.
measure: Change in the number of individuals directly receiving intervention
timeFrame: measured at baseline and every 6 months through 35 months.
measure: Change in the number of households directly receiving intervention
timeFrame: measured at baseline and every 6 months through 35 months.
measure: Change in the number communities directly receiving intervention
timeFrame: measured at baseline and every 6 months through 35 months.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Dakar
country: Senegal
facility: Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche
city: Dakar
country: Senegal
facility: Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & 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.