Evaluation of self sampling method using the menstrual sanitary devices to detect high risk Human Pailloma Virus to simplify cervical cancer screening in India

In this study we would like to findout whether menstrual pads/napkin can be used as a cervical cancer screeningtool.  The objective of the study is to test theDNA extraction from the menstrual pads is good enough in quality and quantityfor HPV testing by PCR technique. The consented women will be requestedto provide the sanitary pads/clothes that will be transported to a central labwhere a PCR based testing will be done for the presence of high risk HPV. Thesewomen will be screened by Hybrid Capture-2 method and the concordance of thetwo tests will be determined. Pilot study will be conducted in 200 women of agegroup 30 to 50. The HPV positive either by HC2/PCR will be further investigatedor treated at NDMCH, Barshi.

After the pilot study, we will conduct apopulation based screening study in 1000 women in a rural community near Barshi -Jamkhed in Maharashtra state. Trained female social workers will counsel,educate and will conduct the interview of all consenting women aged 30 to 50years. The social workers will collect the used sanitary pads or similardevices (clothes) from the women. Theses pads will beprocessed, packed and transported to a central facility at National Institutefor Research in Reproductive Health (NIRRH), ICMR, Mumbai. After extracting thegenetic material it will be tested by PCR methodology for the presence of HPV.  Based on the previus study we assume 10% of this sample will be test positive for HPV. Based on thetest reports a set of cases (HPV positive based on PCR) and controls (HPVnegative based on PCR) will be recalled for further investigation including VIAand or Colposcopy during which a cervical sample will be collected for HPVtesting using HC2 technology. Those with precancerous lesions or cancer will betreated at Nargis Dutt Memorial Cancer Hospital, Barshi. If successful thisapproach can help to overcome the practical challenges in implementing a HPVbased cervical cancer screening programme in our community. This will alsodemonstrate the feasibility of integrating this method into the public healthprogramme such as National Rural Health Mission

The IARC monograph on HPV states that there arenumber of studies reporting that HPV might occasionally be transmitted throughmodes other than sexual activity. To evaluate this aspect, we will perform aparallel study and enroll 50 mother and unmarried daughter pair to determinethe possibility of cross infection by HPV due to reuse of homemade sanitarynapkins. This study will also provide information on the prevalence of HPV inthe menstrual pads of adolescent girls and the role of any horizontal transmissionof HPV due to poor hygiene practices such as reused sanitary pads.