| CTRI Number |
CTRI/2024/01/061833 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mental health conditions among Female sex workers |
|
Scientific Title of Study
|
Probing the dual burden Assessing psychological distress and substance use among female sex workers in Sonagachi Kolkata West Bengal |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monali Bhattacharya |
| Designation |
Master of Public Health Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 50
Department of Health Policy Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7872393604 |
| Fax |
|
| Email |
drmonalibhattacharya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 50
Department of Health Policy Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 50
Department of Health Policy Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
Karnataka 576104
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Material support-Department of health policy, Prasanna School of Public health, MAHE Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Monali Bhattacharya |
| Address |
Master of Public Health Student
Room number 50
Department of Health Policy Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
Karnataka 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varalakshmi Chandra Sekaran |
Prasanna School of Public Health, MAHE Manipal |
Room number - 50,
Department of Health Policy,
Udupi, Karnataka 576104
Udupi
KARNATAKA |
9535810325
varalakshmi.cs@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
It is an observational study |
| Comparator Agent |
NIL |
It is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
18 years and above female sex workers
The participants who are willing to participate
The participants who speak Bangla |
|
| ExclusionCriteria |
| Details |
Less than 18 years female sex workers
Participants who are not willing to participate
Participants who speak other than Bangla |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary goal of this study is to comprehensively investigate and establish the association between psychological distress and substance use among Female Sex Workers (FSWs). The primary outcome aims to fill the existing research gap, identify the determinants and contribute a nuanced understanding of how substance use correlates with psychological distress among FSWs. |
4 months from data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome builds upon the primary research findings and focuses on translating the insights into practical applications. This involves using the data to inform the development of tailored support systems and interventions specifically designed to address the mental health challenges and substance use patterns identified among FSWs. |
4 months from data collection |
|
|
Target Sample Size
|
Total Sample Size="149"
Sample Size from India="149"
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)
|
29/01/2024 |
| 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="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Aims- The study aims to assess the prevalence and determinants of psychological distress and substance use among female sex workers in Sonagachi Kolkata West Bengal
Outcomes - Since there is a research gap about psychological distress and substance use among Female Sex Workers this study can provide substantial information about the association between substance use and psychological distress which then can be used to create support systems and interventions that are suited to their specific needs
The permission has been obtained from Durbar Mahila Samanwaya Committee NGO working at Sonagachi and Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee (KMC/KH IEC) and the data collection will only be carried out after obtaining permission from the CTRI |