Cervical CancerNCT03540069
Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
A study testing Care Group Cervical Cancer Screening Education Curriculum in people with Cervical Cancer and Behavior, run by University of Illinois Chicago at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Behavior
- What is being tested?
- Care Group Cervical Cancer Screening Education Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Oct 2018to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- No additional exclusion criteria exist.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Senegal2 sites
Sénégal Ministère de la Santé et l'Action Sociale Département de Recherche
Dakar
Université Cheikh Anta Diop, Dakar, Senegal Cancer Institute & Institute of Health and Development
Dakar
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
Read the 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
- investigating the access barriers and determinants of initial uptake and
- 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
- the Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake in aim 1,
- the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-management behavior of women in aim 2, and
- 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.
- Conditions
- Cervical Cancer, Behavior
- Being tested
- Care Group Cervical Cancer Screening Education Curriculum
- Medical subject headings
- Uterine Cervical Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Group Cervical Cancer Screening Education CurriculumBehavioural
a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care Group Cervical Cancer Screening Education Curriculum |
| Control | No intervention | No educational program is implemented for each cluster prior to crossover to intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of women screened for the first time, age stratified
Number of women who are screened for cervical cancer
Measured: measured at baseline and every 6 months through 35 months.
Secondary outcomes (6)
Change in the number of women and men recommending the service
Number of women and men recommending that women of screening age get cervical cancer screening
Measured: measured at baseline and every 6 months through 35 months.
Change in the knowledge of cervical cancer
Composite of Knowledge of cervical cancer score from the quantitative survey
Measured: measured at baseline and every 6 months through 35 months.
Change in the number of women being re-screened, age stratified
Number of women being re-screened at 2 years per regional policy
Measured: measured at baseline and every 6 months through 35 months.
Change in the number of individuals directly receiving intervention
Number of individuals communities directly receiving intervention
Measured: measured at baseline and every 6 months through 35 months.
Change in the number of households directly receiving intervention
Number of households directly receiving intervention
Measured: measured at baseline and every 6 months through 35 months.
Change in the number communities directly receiving intervention
Number of communities directly receiving intervention
Measured: measured at baseline and every 6 months through 35 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start3 Oct 2018
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Jon Andrew Dykens, University of Illinois Chicago
- Investigators
- Jon A Dykens, MD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540069
- Sponsor's protocol ID
- 2016-0947
- Other IDs
- 1K01TW010494-01
- Status last verified
- Jun 2022
- First submitted
- 3 Apr 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all IPD that underlie results in a publication
Publications
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.
PubMed 32343755
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers and Sustaining Utilization of a Cervical Cancer Screening Program in Rural Senegal
- ClinicalTrials.gov ID
- NCT03540069
- Acronym / sponsor ID
- 2016-0947
- Conditions
- Cervical Cancer, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- investigating the access barriers and determinants of initial uptake and
- 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
- the Patient-Centered Access Framework to assess the demand-side barriers and facilitators of uptake in aim 1,
- the Integrated Theory of Health Behavior Change to evaluate how a peer education program facilitates self-management behavior of women in aim 2, and
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer Screening Education | Experimental | Behavioral: Care Group Cervical Cancer Screening Education CurriculumContext-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. |
| Control | No intervention | –No educational program is implemented for each cluster prior to crossover to intervention. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (1 listed)
- No additional exclusion criteria exist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Group Cervical Cancer Screening Education Curriculuma multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services. | Behavioural | Cervical Cancer Screening Education |
Primary outcome
Change in the number of women screened for the first time, age stratified
Time frame: measured at baseline and every 6 months through 35 months.
Number of women who are screened for cervical cancer
6 secondary outcomes
Change in the number of women and men recommending the service
Time frame: measured at baseline and every 6 months through 35 months.
Change in the knowledge of cervical cancer
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of women being re-screened, age stratified
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of individuals directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number of households directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Change in the number communities directly receiving intervention
Time frame: measured at baseline and every 6 months through 35 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Background: PubMed 32343755Ongtengco 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.
- Individual participant dataSharing planned: Yes. We will share all IPD that underlie results in a publication
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon A Dykens, MD, MPH principal investigator
University of Illinois Chicago
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Group Cervical Cancer Screening Education Curriculum in people with Cervical Cancer and Behavior, run by University of Illinois Chicago at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Senegal, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of women screened for the first time, age stratified (time frame: measured at baseline and every 6 months through 35 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.