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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Kenya1 site
  • Public Health Facilities in Machakos, Nyeri and Nakuru

    Machakos

Other trials in Kenya

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.

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 groups in NCT06572774
Study groupRoleWhat they receive
C3Link strategiesExperimentalCommunity liaison will host group education sessions and facilitate cervical and breast cancer screening
Receives: Behavioral: C3Link Strategies
C3Link Plus StrategiesExperimentalIn 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 educationActive comparatorParticipants 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted27 Aug 2024
  2. Study start3 Sep 2024
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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)
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

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.

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