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CTRI Number  CTRI/2022/09/045982 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 27/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To check the occurrence of Human Immunodeficiency Virus (HIV) among Indian Men who have Sex with Men (MSM)  
Scientific Title of Study   Incidence of Human Immunodeficiency Virus (HIV) among Indian Men who have Sex with Men  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharmila Pimple 
Designation  Professor and Physician  
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block
Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  pimplesa@tmc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Sharmila Pimple 
Designation  Professor and Physician  
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block
Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  pimplesa@tmc.gov.in  
 
Details of Contact Person
Public Query  
Name  Sharmila Pimple 
Designation  Professor and Physician  
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block
Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  pimplesa@tmc.gov.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR)V.Ramlingaswami Bhavan,Ansari Nagar,New Delhi-110029 India  
National Cancer Institute (NCI) office of Director,31 center Drive, Building 31,Bethesda,Maryland,United State 
 
Primary Sponsor  
Name  Department of Health Research 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmila Pimple  Tata Memorial Hospital  Department of Preventive oncology, 3rd floor, Service block, Tata Memorial Hospital, Dr Ernest Borges road, Parel 400012 Mumbai Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA 		 9223207939

pimplesa@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Tata Memorial Hospital,Parel   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Men who are HIV sero-negative who has had sex with a man  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1.Men age 18 or older
2.HIV sero-negative, as documented by any licensed HIV test according to NACO guidelines.
3.Participants report any sex with a man in the past 6 months.
4.Participants must speak Hindi, Marathi, or English.
5.Participant should not have any plans to move out of the area in the next 12 months and commit to
attending two additional visits one at 6 months and one at 12 months. 
 
ExclusionCriteria 
Details  1.Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site
Investigator, would interfere with adherence to study requirements.
2.Participants with impairments that, in the opinion of the site Investigator, are temporary will be asked to return another day for enrollment.
3.Inability to provide informed consent.
4.History of a sex change operation that would preclude collection of penile or scrotal specimens 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the one-year incidence of HIV among high-risk MSM in India.  52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.To test the feasibility and acceptability of recruiting a sample of 150 high-risk HIV-uninfected MSM using
respondent-driven sampling (RDS) and following them every six months for one year.
2.To produce preliminary descriptive data on:
a. The prevalence and incidence of HPV infection and HPV-associated disease, and STIs other than HPV in
HIV-seronegative MSM in India.
b. Sexual risk behaviors with men and women, as well as data on other potential confounders 		 52 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/03/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   It is well established that men who have sex with men (MSM) have a higher risk of acquiring HIV than other men.This has been demonstrated through studies of both prevalence and incidence in the US, Africa and Asia. It is likely that MSM in India would have a similarly higher risk for infection. Prevalence studies have demonstrated that the proportion of Indian MSM infected with HIV is high.The objective of the study is to evaluate the prevalence of anal and penile HPV infection and prevalence of HPV-associated lesions of the anus and penis amongst men in India having high risk MSM. 
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