| CTRI Number |
CTRI/2024/09/074419 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
NA |
|
Scientific Title of Study
|
Immune markers and their association with genetic signatures among HIV/HPV coinfected women:A study from 2 tertiary care hospitals in Mumbai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayanthi Shastri |
| Designation |
Chair Professor and PI |
| Affiliation |
COE in Research and Training in Infectious Diseases |
| Address |
COE in Research and Training in Infectious Diseases
MUHS, Regional Centre Mumbai, Kasturba Hospital for Infectious Diseases, Sane Guruji Marg, Mumbai
Mumbai
MAHARASHTRA
400011
India |
| Phone |
0 |
| Fax |
|
| Email |
coeimmunologynair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayanthi Shastri |
| Designation |
Chair Professor and PI |
| Affiliation |
COE in Research and Training in Infectious Diseases |
| Address |
COE in Research and Training in Infectious Diseases
MUHS, Regional Centre Mumbai, Kasturba Hospital for Infectious Diseases, Sane Guruji Marg, Mumbai
Mumbai
MAHARASHTRA
400011
India |
| Phone |
0 |
| Fax |
|
| Email |
coeimmunologynair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayanthi Shastri |
| Designation |
Chair Professor and PI |
| Affiliation |
COE in Research and Training in Infectious Diseases |
| Address |
COE in Research and Training in Infectious Diseases
MUHS, Regional Centre Mumbai, Kasturba Hospital for Infectious Diseases, Sane Guruji Marg, Mumbai
Mumbai
MAHARASHTRA
400011
India |
| Phone |
0 |
| Fax |
|
| Email |
coeimmunologynair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funds of Centre of Excellence in Immunology Research, BYL Nair Ch. Hospital, Mumbai, Maharashtra, India 400008 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Sachee Agrawal |
B.Y.L. Nair Charitable Hospital |
Room 303, Department of Microbiology, College Building, Dr A. L. Nair Marg, Mumbai Central. Mumbai 400008
Mumbai
MAHARASHTRA |
9821131368
drsacheeagrawal@gmail.com |
| Dr Reena Wani |
Dr R.N. Cooper Municipal General Hospital |
HOD room, Department of Obstetrics and Gynaecology, Bhaktivedanta Marg, JVPD Scheme, Mumbai 400056
Mumbai (Suburban)
MAHARASHTRA |
9820146462
reena.wani@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ECARP, TNMC, Mumbai |
Submittted/Under Review |
| IEC, HBTMC, Mumbai |
Approved |
| IEC, MUHS, Nashik |
Approved |
| National AIDS Control Organisation |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: N738||Other specified female pelvic inflammatory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Sexually active women in the age group ≥18 years visiting the Integrated Counselling and Testing Centre (ICTC) for HIV testing. |
|
| ExclusionCriteria |
| Details |
1.Women with history of any ongoing active infections e.g. TB or any other immunomodulatory disease.
2.Women currently on ART therapy, steroid treatment and pre-operative cases.
3.Women who are pregnant.
4.Women undergoing cryotherapy, Loop Electrosurgical Excision Procedure(LEEP), Chemo or radiotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparison of Systemic and Cervical immune expression
2.Influence of the specific HPV genotype and genetic signature on the immune markers during a coinfection.
3.Immunophenotype and cytokine profile of patients infect with HIV, HPV & having a HIV-HPV coinfection
4.Comparison of Systemic and Cervical immune expression
|
As this is an observational study there are no defined time lines. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is an exploratory study consisting of sampling of study participants at two sites Site 1: B.Y.L. Nair Hospital, Site 2: Dr. R.N Cooper Municipal General Hospital to achieve a target Sample size 120 women who will be grouped into two cohorts. a) HIV+ women (60) and b) HIV- women (60). The patients visiting the ICTC as part of routine care will undergo pretest counselling and consent prior to blood collection for HIV testing (1st visit to the ICTC). The patients will be called to ICTC after 24hrs to colectys the HIV report and will undergo post-test counselling irrespective of the HIV test result. At this timepoint, after obtaining consent from the patient the peripheral blood and cervical sample will be collected at the respective site. Based on the HPV results, the women will further be grouped into 4 sub-groups: HIVpos-HPVpos, HIVneg-HPVpos, HIVpos-HPVneg, HIVneg HPV neg. |