Abstract
BackgroundCervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. This study aims at evaluating the efficacy of a topical antiviral drug named AV2® as a treatment for HPV-associated lesions of the cervix.MethodsWomen will undergo cytology sampling, HPV testing and Visual inspection of the cervix after application of 5% acetic acid (VIA). VIA-positive women will be randomized to one of two groups to receive treatment by either AV2®or placebo. They will undergo control examinations after two months and after six months. In case of persistent lesions on VIA, treatment by cryotherapy will be done. The primary outcomes will be the change of lesions, the clearance of HPV DNA, and the correlation of the two 2 months after treatment with AV2®.ConclusionThis study is the first large-scale study in Africa to evaluate systematically the efficacy and safety of a topical antiviral drug for the treatment of HPV— associated lesions of the cervix. Its findings will direct the planning of suitable algorithms for CC screening and treatment.Clinical trial registrationClinicalTrials.gov – Unique identifier: NCT02346227, registered on November 8, 2014.
Highlights
Cervical cancer (CC) is the third most common cancer in women worlwide with an estimated 530 000 new cases per year
When human papillomavirus (HPV) infection persists in the cervix, it can induce changes which constitute the precancerous lesions of the cervix (PLC), called dysplasia or cervical intraepithelial neoplasia (CIN)·CIN is asymptomatic and progresses to CC over a prolonged period of time (7–20 years)
According to the WHO studies, visual inspection with acetic acid (VIA) does show better performance that allow its use as a cervical cancer screening test, especially in the frame of « see and treat approach » (SAT) [16,17,18]
Summary
Cervical cancer (CC) is the third most common cancer in women worlwide with an estimated 530 000 new cases per year. Visual inspection of the cervix after application of 5% acetic acid (VIA) is recommended as a screening tool in low-resource settings with no acces to HPV testing or cytology screening It has limited specificity but a high sensitivity, is cost-effective and provides immediate results [6,7]. Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. Clinical trial registration: ClinicalTrials.gov – Unique identifier: NCT02346227, registered on November 8, 2014
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