Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572774
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Community Clinic Model to Improve Early Detection of Breast and Cervical Cancers in Kenya
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Integrated Community Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C3Link
Brief Summary:
Kenya has a high incidence of breast and cervical cancers and most women are diagnosed with late-stage disease The investigators will conduct a study to assess the effectiveness and cost-effectiveness of strategies to increase the uptake of cancer screening and completion of recommended diagnostic and treatment services The findings can be used to design optimal approaches and plan investments in infrastructure to scale up implementation of breast and cervical cancer screening
Detailed Description:
Kenya has a high incidence of breast and cervical cancers and most women are diagnosed with late-stage disease Implementing effective programs to screen and detect these cancers at an early stage could substantially decrease the high mortality Kenya has been increasing access to cancer screening but less than one-sixth of eligible women have ever received breast and cervical cancer screening
The goal of the study is to assess the effectiveness and cost-effectiveness of multicomponent strategies to increase the uptake of breast and cervical cancer screening A key gap that perpetuates the low screening rates in Kenya is the lack of community-clinic linkages There is evidence that women are often unaware of the screening services offered in facilities and even among those who are aware there is lack of motivation anticipated or perceived stigma and reduced self-efficacy to undergo screening The investigators will conduct a pragmatic cluster randomized trial to evaluate the screening outcomes including screening uptake diagnostic test completion and treatment initiation and implementation outcomes to support scale-up The investigators will test two multicomponent packages of strategies 1 Cancer Community-Clinic Linkage C3Link Core Community health volunteer CHV-delivered group education for women and family members to increase screening uptake in the community setting and practice facilitation to improve the screening process and develop team-based care with CHV participation in the clinic setting 2 C3Link Plus C3Link Core strategies along with a sequential series of individual strategies that increase in intensity at 3-month intervals women who remain unscreened will first receive one-on-one education second motivational interviewing and finally navigation to address specific barriers
The investigators will implement the study across 27 communities in Kenya to address the following three specific aims Aim 1 Conduct a cluster randomized trial to assess short-term intervention implementation phase and longer-term impacts maintenance phase of the two packages of multicomponent strategies on breast and cervical cancer screening outcomes along the continuum of care compared to enhanced standard of care communities receiving a messaging campaign only Aim 2 Use a mixed-methods approach to assess and compare multilevel implementation outcomes of the package of strategies focusing on acceptability feasibility appropriateness fidelity and sustainability Aim 3 Perform cost-effectiveness and return-on-investment analysis to support scale-up of an effective package of implementation strategies across Kenya and other sub-Saharan African countries The Kenyan Ministry of Health can use the findings from this study to design optimal approaches and plan investments in screening infrastructure to scale up implementation of guideline recommendations The lessons learned can be applied to other sub-Saharan African settings
The goal of the study is to assess the effectiveness and cost-effectiveness of multicomponent strategies to increase the uptake of breast and cervical cancer screening A key gap that perpetuates the low screening rates in Kenya is the lack of community-clinic linkages There is evidence that women are often unaware of the screening services offered in facilities and even among those who are aware there is lack of motivation anticipated or perceived stigma and reduced self-efficacy to undergo screening The investigators will conduct a pragmatic cluster randomized trial to evaluate the screening outcomes including screening uptake diagnostic test completion and treatment initiation and implementation outcomes to support scale-up The investigators will test two multicomponent packages of strategies 1 Cancer Community-Clinic Linkage C3Link Core Community health volunteer CHV-delivered group education for women and family members to increase screening uptake in the community setting and practice facilitation to improve the screening process and develop team-based care with CHV participation in the clinic setting 2 C3Link Plus C3Link Core strategies along with a sequential series of individual strategies that increase in intensity at 3-month intervals women who remain unscreened will first receive one-on-one education second motivational interviewing and finally navigation to address specific barriers
The investigators will implement the study across 27 communities in Kenya to address the following three specific aims Aim 1 Conduct a cluster randomized trial to assess short-term intervention implementation phase and longer-term impacts maintenance phase of the two packages of multicomponent strategies on breast and cervical cancer screening outcomes along the continuum of care compared to enhanced standard of care communities receiving a messaging campaign only Aim 2 Use a mixed-methods approach to assess and compare multilevel implementation outcomes of the package of strategies focusing on acceptability feasibility appropriateness fidelity and sustainability Aim 3 Perform cost-effectiveness and return-on-investment analysis to support scale-up of an effective package of implementation strategies across Kenya and other sub-Saharan African countries The Kenyan Ministry of Health can use the findings from this study to design optimal approaches and plan investments in screening infrastructure to scale up implementation of guideline recommendations The lessons learned can be applied to other sub-Saharan African settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None