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NCT03514459Completed

Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya

Randomized Controlled Trial of an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya

Source: ClinicalTrials.gov · Last updated 22 May 2024

Brief summary (registry, in English)

Cervical cancer is the most common cancer in women in sub-Saharan Africa, and the majority of cervical cancer mortality occur in low and middle income countries (LMICs). Many of the disparities between high and LMICs are attributed to differences in screening. Kenyan guidelines recommend screening with visual inspection methods followed by treatment of pre-cancerous lesions with cryotherapy and loop electrosurgical excision procedure (LEEP). Implementation of these are poor with only 14% of Kenyan women ever having been screened for cervical cancer as of 2014. To address this implementation gap, this application proposes three aims. In Aim 1, the investigators will describe the cervical cancer screening care cascade, from identification of female clients age 21-65 years old, through referral for follow-up of clients with positive or suspicious screens, in family planning (FP) clinics in Mombasa County. Following characterization of this cascade, an analysis will be conducted of correlates of failure to screen for cervical cancer in FP clients seen over a one-year period in Mombasa County. Aim 2 will test whether SAIA increases cervical cancer screening compared to usual procedures in a cluster randomized trial in 20 FP clinics in Mombasa County. Finally, in Aim 3, the investigators will determine the cost and budget impact of using SAIA to increase cervical cancer screening in FP clinics in Mombasa County. The results of this study have the potential to improve cervical cancer screening, and inform policy in the Mombasa DOH for a fiscally responsible evidenced-based approach for cervical cancer screening. The long-term goal is to decrease cervical cancer mortality and improve women's health.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
19 Apr 2018
Start date
29 Jan 2020
Primary completion date
31 Jul 2021
Lead sponsor
University of Washington
NCT number
NCT03514459

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 29 Jan 2020 to the primary completion date, 31 Jul 2021
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any clinic that is expected to be closed during part or all of the SAIA intervention period will be excluded. Any FP clinic that was previously included in the FP HIV SAIA trial will be excluded.
    • FP clinic managers and staff:

Other

  • These clinic managers can be male or female.

Who the study is looking for

  • All FP clinics that receive County-supplied FP products will be eligible to participate.
  • Any FP clinic manager that is 18 years and older is eligible to be interviewed.

Criteria the registry did not label

  • For FP Clinics:

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Family planning clinics
Coordinator of this site? Confirm its status
MombasaKenyaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.