Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya (DADA-LINK)

Kenyatta National Hospital

Status: Enrolling

Conditions: HPV DNA; Cervical Cancer Screening; Cervical Cancer

Treatments: Behavioral: DADA LINK

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07050745

P864/11/2023

U54CA284036 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,980 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Women ages 25-49 years

Exclusion criteria

• Pregnant women
• Women ≤6 weeks postpartum
• Women already confirmed to have cervical cancer

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,980 participants in 2 patient groups

DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support

Experimental group

Description:

Intervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support.

Treatment:

Behavioral: DADA LINK

Routine standard of care for cervical cancer screening, linkage and treatment

No Intervention group

Description:

Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment