This clinical trial studies whether the single-visit approach (SVA)-screen-and-treat (SAT) method with (+) thermal ablation increases the treatment of precancerous cervical lesions among women in Kenya. Prevention, screening, and early detection are important in cancer control. Despite this, screening and treatment of screen positive lesions remain low among women in Kenya. The SVA-SAT method is a screening approach that uses visual inspection with acetic acid (VIA) to identify patients with precancerous lesions. Patients with precancerous lesions are treated on the same day as the screening visit. TA is a procedure using heat to remove tissue or a part of the body, or destroy its function. It can be used to treat precancerous cervical lesions. Using SVA-SAT+TA may lower patient anxiety of waiting for a diagnosis as well as lower the number of times the patient returns for clinic visits. This may increase the treatment of precancerous cervical lesions among women in Kenya.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05472311.
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PRIMARY OBJECTIVES:
I. Develop a dissemination and implementation strategy to introduce SVA-SAT+TA that effectively accounts for the heterogeneity of the client, provider, and system inputs.
II. Deliver the SVA-SAT+TA intervention at scale in ten reproductive health clinics and evaluate implementation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
III. Compare the cost and budget impact of SVA-SAT+TA to SVA-SAT using cryotherapy.
OUTLINE:
AIM I: Participants complete an in-depth interview or attend a stakeholder workshop on study.
AIM II:
BASELINE DATA PERIOD: Reproductive health (RH) clinics complete a baseline data collection period for a minimum of 6 months prior to introduction of the intervention.
RH clinics are then cluster randomized to start intervention delivery at 1 of the 3 study steps (waves) to stagger the timing of the start of the SVA-SAT+TA intervention and patients are assigned to receive the intervention at the time during which their clinic was randomized.
TRAINING PHASE: RH clinics receive training on thermal ablation techniques, inclusive of refresher training on visual inspection with acetic acid (VIA)/visual inspection with Lugol's iodine (VILI) as part of single-visit-approach as per International Agency for Research on Cancer (IARC) guidelines for one week.
INTENSIVE IMPLEMENTATION PHASE: RH clinics receive on-going technical support with assessment of fidelity to SVA-SAT +TA implementation for 12 months. RH clinics provide programmatic data, receive supportive supervision from the county reproductive health coordinator or designee quarterly, receive refresher trainings, participate in research meetings, training sessions on data completion, and provide input on project implementation processes. Patients undergo SVA-SAT screening with VIA on study. Patients with screen positive lesions undergo TA on study.
MAINTENANCE PHASE: RH clinics receive reduced technical support with assessment of fidelity to SVA-SAT +TA implementation for 12 months. RH clinics continue to provide programmatic data. Patients undergo SVA-SAT screening with VIA on study. Patients with screen positive lesions undergo TA on study.
HPV-SUB STUDY: Patients treated with TA undergo cervical swab sample collection on day 1 prior to treatment and 6 months post treatment by the primary provider at the clinic.
After completion of study intervention, patients are followed up at 1 week and 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorNelly Rwamba Mugo
