Cervical CancerDADA-LINKNCT07050745
Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
A study testing DADA LINK in people with Cervical Cancer and Cervical Cancer Screening, run by Kenyatta National Hospital at 1 site in Kenya.
Trial summary
This study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Screening, HPV DNA
- What is being tested?
- DADA LINK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 1 siteKenya
- Study dates
- 1 Dec 2025to Dec 2026
- 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 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ages 25-49 years
Who cannot join
- Pregnant women
- Women ≤6 weeks postpartum
- Women already confirmed to have cervical cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Kenyatta National Hospital
Nairobi
Agnes K Karume, MBChB, MBA, MPH, +254715181283, karumeagnes@gmail.com
Millicent Masinde, MBChB, MMed, Fell.Gyn Oncology, +254721243740, masinde@uw.edu
About this study
This study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Study staff at each clinic will abstract data on cervical cancer screening and triage/treatment. Clinics randomized to the intervention arm will have care coordinators who motivate clinic staff to adhere to cervical cancer care guidelines, conduct patient exit surveys to assess intervention fidelity, and support care coordination through use of the mHealth platform (WEMA).
Read the detailed description
The highest global incidence of cervical cancer is in sub-Saharan Africa, and it is the leading cause of cancer mortality among women in Kenya. Barriers to cervical cancer screening and treatment have been identified at the patient-, provider-, and facility-level, demonstrating the need for a multi-strategy approach to enhance cervical cancer control. In this research study, formative qualitative research and clinic mapping processes were conducted with primary care clinics in Nairobi County to select contextually appropriate strategies targeting the primary barriers to cervical cancer screening and linkage to treatment in Nairobi, Kenya. This study seeks to evaluate the implementation and effectiveness of a care package designed to enhance the early detection and treatment of precancerous cervical lesions among women aged 25-49 years in Kenya.
Trained study staff will abstract patient data from existing clinic records to monitor and assess rates of cervical cancer screening and linkage to treatment.
Study staff at the intervention clinics (i.e., care coordinators) will motivate and support clinic staff to adhere to cervical cancer care guidelines. Care coordinators will use a mHealth platform (i.e., WEMA) tailored for use in primary care clinics in Kenya to track patient exit interview responses regarding uptake of HPV self-sampling kits and to support clinic staff by tracking cervical cancer screening, follow-up, and linkage to treatment, when appropriate. WEMA will serve as an information management system in the intervention clinics, providing a data dashboard to track patient follow-up and enable text communication with patients.
- Conditions
- Cervical Cancer, Cervical Cancer Screening, HPV DNA
- Being tested
- DADA LINK
- Keywords
- cervical cancer, screening, m-Health, linkage to treatment, VIA, HPV, HPV self-sampling
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DADA LINKBehavioural
Intervention facilities will receive the DADA-LINK intervention, comprised of:
- HPV self-sampling: We will provide clinics with HPV self-sampling kits to administer to eligible patients.
- Care Navigation: One study-supported non-physician care navigator will be assigned to each clinic to support the clinic staff. These trained individuals will be responsible for managing data collection through the mHealth platform to aid the coordination of services and for motivating the clinic staff to adhere to cervical cancer care guidelines.
- mHealth support for cervical cancer screening and treatment linkage: The WEMA application is a low-cost and highly adaptable open-source application designed for cervical cancer data monitoring and evaluation. Relevant patient information and data on uptake of cervical cancer screening and triage/treatment will be entered in the WEMA platform. The platform will additionally be used to send text messages to patients to facilitate clinic attendance.
| Study group | Role | What they receive |
|---|---|---|
| DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support | Experimental | Intervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support. Receives: Behavioral: DADA LINK |
| Routine standard of care for cervical cancer screening, linkage and treatment | No intervention | Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary implementation outcome: Cervical cancer screening uptake
Binary endpoint (Yes/No) based on completion of the HPV self-sampling (return of the self-collected HPV swab) or having conducted VIA
Measured: 1 day (on the day of clinic visit)
Primary effectiveness outcome: Receipt of triage and/or treatment
Binary endpoint (Yes/No) based on receipt of triage and/or treatment
Measured: within 12 months
Secondary outcomes (4)
Secondary effectiveness outcomes: Form of triage and/or treatment received
Receipt of:
- Triage (any next step not exclusively counseling or receipt of results) (yes/no);
Measured: within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Description: Receipt of: b) Treatment (must be some sort of therapeutic procedure) (yes/no)
Measured: within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Description: Receipt of: c) Triage and treatment (any next step not exclusively counseling or receipt of results; must be some sort of triage or therapeutic procedure) (yes/no)
Measured: within 12 months
Communication of HPV test result to patients via mHealth messages
Binary endpoint (Yes/No) based on confirmation of HPV test results being sent to the participant's phone via mhealth application (WEMA).
Measured: Within 10 days of results being made available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized hybrid type 2 trial will evaluate cervical cancer screening implementation and effectiveness across 20 facilities in Nairobi, Kenya offering primary healthcare. Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment. Intervention facilities will provide DADA LINK (HPV self-sampling, care navigators, and mHealth support for cervical cancer screening and treatment linkage).
- Masking
- None (open label)
- Enrolment
- 1,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenyatta National Hospital
- Sponsor type
- Other government
- Collaborators
- Emory University, University of Washington, National Cancer Institute (NCI), Kenya Ministry of Health, Queen's University, University of Nairobi
- Responsible party
- Sponsor
- Investigators
- Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD, Principal investigator, University of NairobiLeslie Johnson, MPH, MLitt, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050745
- Sponsor's protocol ID
- P864/11/2023
- Other IDs
- U54CA284036
- Acronym
- DADA-LINK
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
- ClinicalTrials.gov ID
- NCT07050745
- Acronym / sponsor ID
- DADA-LINK / P864/11/2023
- Conditions
- Cervical Cancer, Cervical Cancer Screening, HPV DNA
- Keywords
- cervical cancer, screening, m-Health, linkage to treatment, VIA, HPV, HPV self-sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- Kenyatta National HospitalOther government
- Collaborators
- Emory University, University of Washington, National Cancer Institute (NCI), Kenya Ministry of Health, Queen's University, University of Nairobi
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jul 2025 (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 study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Study staff at each clinic will abstract data on cervical cancer screening and triage/treatment. Clinics randomized to the intervention arm will have care coordinators who motivate clinic staff to adhere to cervical cancer care guidelines, conduct patient exit surveys to assess intervention fidelity, and support care coordination through use of the mHealth platform (WEMA).
Detailed description
The highest global incidence of cervical cancer is in sub-Saharan Africa, and it is the leading cause of cancer mortality among women in Kenya. Barriers to cervical cancer screening and treatment have been identified at the patient-, provider-, and facility-level, demonstrating the need for a multi-strategy approach to enhance cervical cancer control. In this research study, formative qualitative research and clinic mapping processes were conducted with primary care clinics in Nairobi County to select contextually appropriate strategies targeting the primary barriers to cervical cancer screening and linkage to treatment in Nairobi, Kenya. This study seeks to evaluate the implementation and effectiveness of a care package designed to enhance the early detection and treatment of precancerous cervical lesions among women aged 25-49 years in Kenya.
Trained study staff will abstract patient data from existing clinic records to monitor and assess rates of cervical cancer screening and linkage to treatment.
Study staff at the intervention clinics (i.e., care coordinators) will motivate and support clinic staff to adhere to cervical cancer care guidelines. Care coordinators will use a mHealth platform (i.e., WEMA) tailored for use in primary care clinics in Kenya to track patient exit interview responses regarding uptake of HPV self-sampling kits and to support clinic staff by tracking cervical cancer screening, follow-up, and linkage to treatment, when appropriate. WEMA will serve as an information management system in the intervention clinics, providing a data dashboard to track patient follow-up and enable text communication with patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized hybrid type 2 trial will evaluate cervical cancer screening implementation and effectiveness across 20 facilities in Nairobi, Kenya offering primary healthcare. Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment. Intervention facilities will provide DADA LINK (HPV self-sampling, care navigators, and mHealth support for cervical cancer screening and treatment linkage).
| Arm | Type | Receives |
|---|---|---|
| DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support | Experimental | Behavioral: DADA LINKIntervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support. |
| Routine standard of care for cervical cancer screening, linkage and treatment | No intervention | –Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women ages 25-49 years
Key exclusion criteria (3 listed)
- Pregnant women
- Women ≤6 weeks postpartum
- Women already confirmed to have cervical cancer
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 |
|---|---|---|
| DADA LINKIntervention facilities will receive the DADA-LINK intervention, comprised of: 1. HPV self-sampling: We will provide clinics with HPV self-sampling kits to administer to eligible patients. 2. Care Navigation: One study-supported non-physician care navigator will be assigned to each clinic to support the clinic staff. These trained individuals will be responsible for managing data collection through the mHealth platform to aid the coordination of services and for motivating the clinic staff to adhere to cervical cancer care guidelines. 3. mHealth support for cervical cancer screening and treatment linkage: The WEMA application is a low-cost and highly adaptable open-source application designed for cervical cancer data monitoring and evaluation. Relevant patient information and data on uptake of cervical cancer screening and triage/treatment will be entered in the WEMA platform. The platform will additionally be used to send text messages to patients to facilitate clinic attendance. | Behavioural | DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support |
Primary outcome
Primary implementation outcome: Cervical cancer screening uptake
Time frame: 1 day (on the day of clinic visit)
Binary endpoint (Yes/No) based on completion of the HPV self-sampling (return of the self-collected HPV swab) or having conducted VIA
Primary effectiveness outcome: Receipt of triage and/or treatment
Time frame: within 12 months
Binary endpoint (Yes/No) based on receipt of triage and/or treatment
4 secondary outcomes
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time frame: within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time frame: within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time frame: within 12 months
Communication of HPV test result to patients via mHealth messages
Time frame: Within 10 days of results being made available
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 12 Jan 2026.
- The DADA LINK project contributes to the BREAKTHROUGH Center by developing a project platform with multidisciplinary expertise that conducts innovative and impactful implementation research focused on closing gaps in cervical cancer continuum in KenyaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD principal investigator
University of Nairobi
Leslie Johnson, MPH, MLitt, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DADA LINK in people with Cervical Cancer and Cervical Cancer Screening, run by Kenyatta National Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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?
Contact Agnes K Karume, MBChB, MBA, MPH (+254715181283, karumeagnes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary implementation outcome: Cervical cancer screening uptake (time frame: 1 day (on the day of clinic visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.