| CTRI Number |
CTRI/2013/11/004132 [Registered on: 07/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Cervical cancer prevention in HIV infected women in Pune, India |
|
Scientific Title of Study
|
Cervical cancer prevention in HIV infected women in Pune, India |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Joshi |
| Designation |
Associate Professor, HCJMRI and Senior Scientist, Prayas |
| Affiliation |
HCJMRI and Prayas |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Jehangir Hospital Premises, 32 Sassoon Road Pune
Amrita Clinic, Karve Road Corner, Deccan Gymkhana Corner,
Pune
MAHARASHTRA
411001
India |
| Phone |
919881132506 |
| Fax |
02025420337 |
| Email |
smitanjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Smita Joshi |
| Designation |
Senior Scientist |
| Affiliation |
Prayas and HCJMRI & JCDC, Jehangir Hospital Pune |
| Address |
Prayas
Amrita Clinic
Athawale Corner
Karve Road Corner
Deccan Gymkhana, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
919881132506 |
| Fax |
|
| Email |
smitanjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Joshi |
| Designation |
Associate Professor, HCJMRI and Senior Scientist, Prayas |
| Affiliation |
HCJMRI and Prayas |
| Address |
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Jehangir Hospital Premises, 32 Sassoon Road Pune
Amrita Clinic, Karve Road Corner, Deccan Gymkhana Corner,
Pune
MAHARASHTRA
411001
India |
| Phone |
919881132506 |
| Fax |
02025420337 |
| Email |
smitanjoshi@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Maharashtra Foundation (NY, USA), research donations from various organizations (Cipla, Serum Institute of India, Nuper Pharmaceuticals, Emcure, Ranbaxy, personal donations) and some intramural funds |
|
Primary Sponsor
Modification(s)
|
| Name |
Prayas |
| Address |
Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana, Pune 411004
|
| Type of Sponsor |
Other [Non-profit, non-governmental NGO] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Joshi |
Hirabai Cowasji Jehangir Medical Research Institute |
Jehangir Hospital Premises,
32 Sassoon Road, Pune 411001
Pune
MAHARASHTRA |
919881132506
smitanjoshi@gmail.com |
| Dr Smita Joshi |
Prayas |
Amrita Clinic, Athawale corner, Karve Road Corner,Pune
Pune
MAHARASHTRA |
9881132506
smitanjoshi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of Prayas |
Approved |
| Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV-infected women, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical cancer screening of all enrolled women using VIA, VILI, cytology and HPV testing |
Eligible HIV-infected women were screened using multiple screening tests to detect CIN. All women underwent colposcopy and women with colposcopically detected lesion underwent cervical biopsy and treatment using cold coagulation (if eligible). Women who were not eligible were referred for LEEP. Women with cervical cancer were referred for anti-cancer treatment. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. HIV-infected women
2. Willing to sign an informed consent form
3. Having an intact uterus |
|
| ExclusionCriteria |
| Details |
1. Women who have undergone hysterectomy
2. Women having a debilitating health condition
3. Women with prior history of any procedure on the cervix |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Test performance of cytology, VIA, VILI and HPV testing to detect CIN 2-3 lesions
2. Prevalence and type distribution of high-risk HPV types in HIV-infected women and its correlation with cervical abnormalities
3. Distribution of HPV types in CIN and in cervical cancer specimens in HIV-infected
|
Baseline at screening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of cold coagulation in curing and preventing recurrence of CIN 2-3 lesions in HIV-infected women |
Initially after 6 months and then every year thereafter |
|
|
Target Sample Size
|
Total Sample Size="1153"
Sample Size from India="1153"
Final Enrollment numbers achieved (Total)= "1153"
Final Enrollment numbers achieved (India)="1153" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
09/09/2010 |
| Date of Study Completion (India) |
30/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="11"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Joshi S, Sankaranarayanan R, Muwonge R, Kulkarni V, Somanathan T, Divate U. Screening of cervical neoplasia in HIV-infected women in India. AIDS. 2013 Feb 20;27(4):607-15. doi: 10.1097/QAD.0b013e32835b1041.
2. Joshi S, Babu JM, Jayalakshmi D, Kulkarni V, Divate U, Muwonge R, Gheit T, Tommasino M, Sankaranarayanan R, Pillai MR. Human papillomavirus infection among human immunodeficiency virus-infected women in Maharashtra, India. Vaccine. 2014 Jan 4. pii: S0264-410X(13)01803-3. doi: 10.1016/j.vaccine.2013.12.060.
3.Joshi S, Muwonge R, Kulkarni V, Deodhar K, Mandolkar M, Lucas E, Sankaranarayanan R. Incidence of cervical intraepithelial neoplasia in women infected with human immunodeficiency virus (HIV) with no evidence of disease at baseline: results of a prospective cohort study with up to 6.4 years of follow-up from India. Int J Cancer. 2018 Aug 22. doi: 10.1002/ijc.31826.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Invasive cervical
cancer is an AIDS defining illness. Observational studies in different regions
of the world indicate that human immunodeficiency virus (HIV) infected women
are at high risk for oncogenic human papillomavirus (HPV) infection and at 5-
to 10-fold increased risk of developing cervical cancer. HPV infection among
HIV infected women is more persistent and progressive than in HIV-negative
women. Cervical cancers in HIV infected women present with aggressive natural
history, advanced disease and with metastasis in unusual sites and often
respond poorly to treatment due to the large volume clinical disease. Thus,
cervical cancer prevention among HIV-infected women assumes major priority,
given the high risk of HPV infection, cervical precursor, and malignant lesions
among them. In spite of large burden of both HIV infection and cervical cancer,
there are very few studies in India
that have addressed the association between them and the ways and means to
control the disease. This project proposal is intended to comprehensively
address prevention of cervical neoplasia in HIV-infected women in low- and
medium-resourced settings. |