Patient-centered cervical cancer screening and treatment linkage program in Nairobi
Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
This project will try a multi-part care approach (DADA LINK) using care coordinators and an mHealth app to help women ages 25–49 in Nairobi get screened for cervical cancer and linked to treatment when needed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1980 (estimated) |
| Ages | 25 Years to 49 Years |
| Sex | Female |
| Sponsor | Kenyatta National Hospital Government |
| Locations | 1 site (Nairobi) |
| Trial ID | NCT07050745 on ClinicalTrials.gov |
What this trial studies
Clinics in Nairobi are randomized to implement a multi-component care package (DADA LINK) that uses clinic-based care coordinators and the WEMA mHealth platform to improve HPV self-sampling uptake, screening follow-up, and linkage to treatment for precancerous cervical lesions. Trained study staff will abstract routine clinic records to monitor screening, triage, and treatment rates over a 12-month intervention period with an additional 6-month follow-up to measure costs and maintenance. Care coordinators will support clinic staff to follow cervical cancer care guidelines and will collect patient exit surveys to track intervention fidelity and uptake. The intervention was selected after formative qualitative work and clinic mapping to address barriers at the patient, provider, and facility levels in Nairobi.
Who should consider this trial
Good fit: Women aged 25–49 years receiving care at participating Nairobi clinics who are not pregnant, not within six weeks postpartum, and not already confirmed to have cervical cancer.
Not a fit: Pregnant women, women ≤6 weeks postpartum, people already confirmed to have cervical cancer, and individuals outside the 25–49 age range are not eligible and would not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase early detection and timely treatment of precancerous cervical lesions, reducing future cervical cancer cases and deaths.
How similar studies have performed: Previous work in low- and middle-income settings has shown promise for HPV self-sampling and mHealth-supported linkage to care, but multi-component, clinic-level coordination packages like DADA LINK are less widely tested in Kenyan primary care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Women ages 25-49 years Exclusion Criteria: * Pregnant women * Women ≤6 weeks postpartum * Women already confirmed to have cervical cancer
Where this trial is running
Nairobi
- Kenyatta National Hospital — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD — University of Nairobi
- Study coordinator: Agnes K Karume, MBChB, MBA, MPH
- Email: karumeagnes@gmail.com
- Phone: +254715181283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.