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CTRI Number  CTRI/2018/07/014894 [Registered on: 16/07/2018] Trial Registered Prospectively
Last Modified On: 29/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Self care interventional package : Promotion of sexual health among men who have sex with men, Chandigarh India 
Scientific Title of Study   A randomized control trial to assess the effectiveness of self care interventional package on promotion of sexual health, among men who have sex with men (MSM) in UT, Chandigarh. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Devi 
Designation  MSc. Nursing student 
Affiliation  BSc. Nursing 
Address  National institute of nursing education PGIMER Chandigarh India
Village Bid P/O-Gahar Tehsil- Sarkaghat Distt-Mandi Himachal Pradesh
Chandigarh
CHANDIGARH
Anjali Devi
India 
Phone  8988262606  
Fax    
Email  anjali11340@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karobi Das 
Designation  Lecturer NINE 
Affiliation  National institute of nursing education 
Address  National institute of nursing education PGIMER Chandigarh India
PGIMER, sector 12 Chandigarh India
Chandigarh
CHANDIGARH
160012
India 
Phone  9876055366  
Fax    
Email  karobi20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karobi Das 
Designation  Lecturer NINE 
Affiliation  National institute of nursing education 
Address  National institute of nursing education PGIMER Chandigarh India
PGIMER, sector 12 Chandigarh India
Chandigarh
CHANDIGARH
160012
India 
Phone  9876055366  
Fax    
Email  karobi20@gmail.com  
 
Source of Monetary or Material Support  
Nill 
 
Primary Sponsor  
Name  Dr Karobi Das 
Address  Lecturer at National institute of nursing education PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Anjali Devi  State AIDS Society Chandigarh  1. Indian public health association (IPHA) Indira Colony 2. Family planning associa(FPAI) Panchkula
Chandigarh
CHANDIGARH 		 8988262606

anjali11340@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate institute of medical education and research Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To promote sexual health among men who have sex with men 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  self care interventional package on promotion of sexual health  counselling,education,routine health checkup 
Comparator Agent  one group will be experiment another group will be control  interventions are given to experiment group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  Age greater then 18 year.
Regular contact with NGO from last 3 month 
 
ExclusionCriteria 
Details  Suffering from known mental illness. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Promotion of sexual health.
 		 after 3month of giving self care interventional package on sexual health
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in sexual health practices related to :
Use of condom
Use of lubricant
Periodic self assessment of genital and anal area
Use of alcohol or other substance use
Regular medical and diagnostic follow up
use of vaccination
Awwareness and knowledge 		 after 3 month of giving self care interventional package 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/07/2018 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 No publication has been done yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The study objectives are :

1)      To develop and implement the ‘self care interventional package’ on promotion of sexual health, among men who have sex with men (MSM) in  UT, Chandigarh.

2)      To assess the effectiveness of ‘self care interventional package’ on promotion of sexual health, among men who have sex with men (MSM) UT, Chandigarh.

Hypothesis :
 Null hypothesis (H0):  There is no significant difference of sexual health of MSM after implementation of ‘Self care interventional package’ to <0.05 level of  significance.
Research hypothesis (H1): There is a significant improvement in sexual health of MSM after implementation of ‘Self care interventional package’ to < 0.05 level of significance.
 
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