This trial studies the effect of a cervical cancer screen-and-treat strategy with human papillomavirus (HPV) self-testing and thermocoagulation for the detection and treatment of cervical lesions in women from Lilongwe, Malawi. HPV can cause changes or damage on the cervix (i.e. pre-cancerous lesions) that if left untreated, can develop into cervical cancer. Collecting and visually inspecting samples containing cervical and vaginal cells using a vaginal brush may help researchers find out how many women among those screened have HPV. Thermocoagulation involves applying a heated probe to the cervix for approximately 30-40 seconds to destroy abnormal tissues in an effort to prevent cancer development. The screen-and-treat strategy with HPV self-testing and thermocoagulation may help doctors evaluate the detection and treatment of pre-cancerous cervical lesion(s) in women in Malawi.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04092257.
PRIMARY OBJECTIVES:
I. To assess completion of a novel invasive cervical cancer (ICC) screen-and-treat strategy among women in Lilongwe, Malawi, using self-collected vaginal brush for high risk (hr)-HPV testing, followed by same-day visual inspection with acetic acid (VIA) and thermocoagulation for HPV-positive/VIA-positive/ablation-eligible (by colposcopy) women.
II. To determine the 24-week efficacy of thermocoagulation among women, including human immunodeficiency virus (HIV)-positive women, with CIN2/3.
SECONDARY OBJECTIVES:
I. To evaluate performance of the proposed ICC screen-and-treat strategy among women, including HIV-positive women, by estimating overtreatment for women who are HPV-positive/VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.
II. To explore women’s experiences with the proposed ICC screen-and-treat strategy.
EXPLORATORY OBJECTIVES:
I. To evaluate high-risk HPV testing in urine samples for the detection of high-grade cervical precancer and cancer, compared to hr-HPV testing in provider- and self-collected cervicovaginal samples.
II. To evaluate S5 methylation testing in urine samples as a triage test for high-risk HPV positive results, compared to S5 testing in provider- and self-collected cervicovaginal samples.
OUTLINE:
Participants undergo collection of cervical and vaginal cells for hr-HPV testing. Every 10th hr-HPV negative participant and participants who are hr-HPV-positive then undergo same-day VIA with colposcopically-directed cervical biopsy and endocervical curettage (ECC) (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy.
After completion of study treatment, participants are followed up at weeks 24 and 28.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorLameck Chinula
