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"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"

Primary Purpose

Cervical Inflammation and Human Papilloma Virus Performance

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Tab cefixime,Tab Azithromycin
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Inflammation and Human Papilloma Virus Performance

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Sexually active women with clinically diagnosed cervicitis as per NACO guidelines will be enrolled as cases.
  2. Sexually active women with no symptoms of STIs/RTIs and clinically no cervicitis will be enrolled as cases.

Exclusion Criteria:

  1. Pregnant women.
  2. Women not willing to follow up.
  3. Not willing to use barrier contraception if diagnosed with STIs.
  4. Women received antiboitics in last 4 weeks.
  5. women with vaginitis without cervicitis on per speculum examination.
  6. No drug allergy to the treating drugs.
  7. No present or past history of cervical cancer. -

Sites / Locations

  • Tata Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group/Case

Control group

Arm Description

women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group. women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group.A cervico-vaginal swab shall be taken for Lab diagnosis of RTIs along with HPVDNA test on day 1.Women shall be treated with Tab Azithromycin 1gm and Tab Cefixime 400mg stat along with barrier contraception advised.The women will be followed up after 7-14 days .A repeat cervicovaginal swab and HPVDNA shall be repeated.

Women without signs and symptoms of cervicitis or cervico-vaginitis.No intervention will be done in this group

Outcomes

Primary Outcome Measures

Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis

Secondary Outcome Measures

Full Information

First Posted
June 29, 2016
Last Updated
July 8, 2016
Sponsor
Tata Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02830230
Brief Title
"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
Official Title
"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a strong causal association between persisting genital tract infection with Human Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus) cancer.The robust study from India have shown that single round of HPV DNA screening test to significantly reduce the cervical cancer mortality. The above findings are very encouraging since it demonstrates that a simple and reliable HPV DNA test which is now available in low income countries has a potential to be accepted as primary screening test in future. The cross-sectional studies from developed countries from year 1999-2004 which focused to determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%. Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average sensitivity of 79%.Among the developing countries cross-sectional study from India which evaluated test reported sensitivity of only 68.2%. There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA HC2 test between the developed and developing countries to determine CIN2+ Lesions while there is no difference in the specificity. A study that was conducted in Chinese women to detected the prevalence of HPV genotype among women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis as compared to other two groups. So the study will explore if if the presence of untreated co-infections with STIs/RTIs (Sexually transmitted infections/Reproductive tract infections) resulting in cervical inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of blood and excess mucus associated with the conditions leading to low sensitivity of the test in context to Indian Scenario.
Detailed Description
Methodology-The eligible women in the age group of 30-50 years will be screened. Eligibility criteria will be determined. Women with clinical cervicitis as per NACO guidelines on per speculum examination will been rolled as cases after signing the inform consent. Women with no signs and symptoms of cervicitis (No white discharge P/V,No lower Abdominal pain, No urinary symptoms,No dysperunia,No pruritis vulvae,No post coital bleeding)will be enrolled as controls after signing the inform consent. The participants ready to participate will be explained the details and the purpose of the study by Doctor.All the women enrolled in women shall be followed up after 7-14 days. Day 1.Cervical swab from ectocervix and endocervix shall be collected. Additional vaginal swab Will be taken from lateral vaginal wall and posterior fornices for all women enrolled in study.The swabs will be evenly spread on a glass slide and heat fixed. The slides will be put in slide box to be transported to Microbiology Department for Gram staining for Gonococcal, Non-Gonococcal infections,Bacterial Vaginosis,Candida. Next, cervical cells for HPV DNA testing will be collected. The women diagnosed with clinical cervicitis will receive treatment on the spot and advised use to use barrier contraception for 15 days.No treated will be given for the women in enrolled arm i.e women without clinical and lab STIs. Day7-14- All the women enrolled in study shall be followed up after 7-14 days. Women will undergo per-speculum examination and clinical signs of cervicitis or cervicovaginitis will be reassessed again and documented. A repeat cervical swab and vaginal swab shall be collected and send for gram staining for the above mentioned organisms. A repeat, cervical cells for HPV DNA testing will be collected. Women who are positive for HPV DNA and STIs on follow up visits shall be counselled and referred for further evaluation and treatment to appropriate hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Inflammation and Human Papilloma Virus Performance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
508 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group/Case
Arm Type
Experimental
Arm Description
women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group. women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group.A cervico-vaginal swab shall be taken for Lab diagnosis of RTIs along with HPVDNA test on day 1.Women shall be treated with Tab Azithromycin 1gm and Tab Cefixime 400mg stat along with barrier contraception advised.The women will be followed up after 7-14 days .A repeat cervicovaginal swab and HPVDNA shall be repeated.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women without signs and symptoms of cervicitis or cervico-vaginitis.No intervention will be done in this group
Intervention Type
Drug
Intervention Name(s)
Tab cefixime,Tab Azithromycin
Intervention Description
The women with clinical cervicitis will receive treatment for cervicitis.
Primary Outcome Measure Information:
Title
Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sexually active women with clinically diagnosed cervicitis as per NACO guidelines will be enrolled as cases. Sexually active women with no symptoms of STIs/RTIs and clinically no cervicitis will be enrolled as cases. Exclusion Criteria: Pregnant women. Women not willing to follow up. Not willing to use barrier contraception if diagnosed with STIs. Women received antiboitics in last 4 weeks. women with vaginitis without cervicitis on per speculum examination. No drug allergy to the treating drugs. No present or past history of cervical cancer. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharmila A Pimple, MD
Phone
91-2224154379
Email
drsharmilapatil@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kavita V Anand, DGO
Phone
9892191968
Email
drkavitaanand@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reena J Wani, MD
Organizational Affiliation
HBT Medical College & R.N.Cooper Muncipal Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Savita R Karnad, M.SC
Organizational Affiliation
HBT Medical College & R.N.Cooper Muncipal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharmila A Pimple, MD
Phone
91-2224154379
Email
drsharmilapatil@yahoo.com
First Name & Middle Initial & Last Name & Degree
Kavita V Anand, DGO
Phone
9892191968
Email
drkavitaanand@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"

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