Breast CancerC3LinkNCT06572774
Community Clinic Model to Improve Early Detection of Breast and Cervical Cancers in Kenya
A study testing C3Link Strategies in people with Breast Cancer and Cervical Cancer, run by Implenomics at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- C3Link Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,400 participants
- Where
- 1 siteKenya
- Study dates
- 3 Sep 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women will be eligible to participate if they are 30 to 55 years old, due to receive both breast and cervical cancer screening during the study intervention implementation phase based on Kenyan guideline recommendations, not experiencing breast or cervical cancer symptoms (will be referred for diagnostic testing with facilitation support from the study team), not pregnant, fluent in a study language (English,Kiswahili, Kamba, Kalenjin, and Kikuyu) and plan to remain in the community for at least 2 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrated Community Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya
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.
Read the 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.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- C3Link Strategies
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C3Link StrategiesBehavioural
Education sessions and community liaison support to link to services
| Study group | Role | What they receive |
|---|---|---|
| C3Link strategies | Experimental | Community liaison will host group education sessions and facilitate cervical and breast cancer screening Receives: Behavioral: C3Link Strategies |
| C3Link Plus Strategies | Experimental | In addition to group education sessions, the Community Liaison will offer women one-on-one education, counseling and navigation support to address barriers. Receives: Behavioral: C3Link Strategies |
| One-time education | Active comparator | Participants will receive educational brochure on importance of breast and cervical cancer screening Receives: Behavioral: C3Link Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast and cervical cancer screening
The primary endpoint is the proportion who complete both recommended breast and cervical cancer screenings at 24 months
Measured: 24 months
Secondary outcomes (2)
Follow-up diagnostic procedure
Proportion who complete recommended follow-up supplemental or diagnostic procedures (within 3 months of receiving follow-up referral)
Measured: 24 months
Initiation of cancer treatment
Proportion who initiative cancer treatment (within 3 months of diagnosis)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start3 Sep 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
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 Breast CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- We are randomly assigning women to the three study arms. We are also requesting that the women select one caregiver for inclusion in the caregiver education sessions
- Masking
- None (open label)
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implenomics
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, RTI International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572774
- Sponsor's protocol ID
- Imp002
- Acronym
- C3Link
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gakunga R, Mburu L, Ali Z, Krudy M, Inziani M, Katua D, Kerich C, Agoro O, Subramanian S. Integrated Community-Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2026 May 18;15:e87850. doi: 10.2196/87850.
PubMed 42149806
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Community Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya
- ClinicalTrials.gov ID
- NCT06572774
- Acronym / sponsor ID
- C3Link / Imp002
- Conditions
- Breast Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- ImplenomicsUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, RTI International
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 27 Aug 2024 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We are randomly assigning women to the three study arms. We are also requesting that the women select one caregiver for inclusion in the caregiver education sessions
| Arm | Type | Receives |
|---|---|---|
| C3Link strategies | Experimental | Behavioral: C3Link StrategiesCommunity liaison will host group education sessions and facilitate cervical and breast cancer screening |
| C3Link Plus Strategies | Experimental | Behavioral: C3Link StrategiesIn addition to group education sessions, the Community Liaison will offer women one-on-one education, counseling and navigation support to address barriers. |
| One-time education | Active comparator | Behavioral: C3Link StrategiesParticipants will receive educational brochure on importance of breast and cervical cancer screening |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women will be eligible to participate if they are 30 to 55 years old, due to receive both breast and cervical cancer screening during the study intervention implementation phase based on Kenyan guideline recommendations, not experiencing breast or cervical cancer symptoms (will be referred for diagnostic testing with facilitation support from the study team), not pregnant, fluent in a study language (English,Kiswahili, Kamba, Kalenjin, and Kikuyu) and plan to remain in the community for at least 2 years
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| C3Link StrategiesEducation sessions and community liaison support to link to services | Behavioural | C3Link Plus Strategies, C3Link strategies, One-time education |
Primary outcome
Breast and cervical cancer screening
Time frame: 24 months
The primary endpoint is the proportion who complete both recommended breast and cervical cancer screenings at 24 months
2 secondary outcomes
Follow-up diagnostic procedure
Time frame: 24 months
Initiation of cancer treatment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 42149806Gakunga R, Mburu L, Ali Z, Krudy M, Inziani M, Katua D, Kerich C, Agoro O, Subramanian S. Integrated Community-Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2026 May 18;15:e87850. doi: 10.2196/87850.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C3Link Strategies in people with Breast Cancer and Cervical Cancer, run by Implenomics at 1 site in Kenya.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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?
This study is still under way. Results are not available in the source record yet.
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?
Breast and cervical cancer screening (time frame: 24 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 NCT06572774, 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 24 Nov 2025.