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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA284036 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of Washington | OTHER |
| National Cancer Institute (NCI) | NIH |
| Kenya Ministry of Health |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DADA LINK | Behavioral | Intervention facilities will receive the DADA-LINK intervention, comprised of:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effectiveness outcomes: Form of triage and/or treatment received | Receipt of: a) Triage (any next step not exclusively counseling or receipt of results) (yes/no); | within 12 months |
| Secondary effectiveness outcomes: Form of triage and/or treatment received |
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Inclusion Criteria:
- Women ages 25-49 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnes K Karume, MBChB, MBA, MPH | Contact | +254715181283 | karumeagnes@gmail.com | |
| Millicent Masinde, MBChB, MMed, Fell.Gyn Oncology | Contact | +254721243740 | dr.msmillies@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD | University of Nairobi | Principal Investigator |
| Leslie Johnson, MPH, MLitt, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenyatta National Hospital | Recruiting | Nairobi | Kenya |
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| Label | URL |
|---|---|
| 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 Kenya | View source |
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All IPD that underlie results in a publication
At the end of the project
All IPD submitted as part of the trial publication will be accessible
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER_GOV |
| Queen's University | OTHER |
| University of Nairobi | OTHER |
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).
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Description: Receipt of: b) Treatment (must be some sort of therapeutic procedure) (yes/no) |
| 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) | 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). | Within 10 days of results being made available |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |