| CTRI Number |
CTRI/2025/09/094253 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Health and Well-being of Women engaged in Sex Work in Dewas |
|
Scientific Title of Study
|
Quality of life, health care utilization patterns, and stakeholder perspectives among female sex workers in Dewas, Madhya Pradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartavya Kumar Tiwari |
| Designation |
PhD Scholar |
| Affiliation |
IIHMR University |
| Address |
IIHMR University
1 Prabhu Dayal Marg, Sanganer, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9109682588 |
| Fax |
|
| Email |
kartavya.phd9@iihmr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Piyusha Majumdar |
| Designation |
Associate Professor |
| Affiliation |
IIHMR University |
| Address |
IIHMR University
1 Prabhu Dayal Marg, Sanganer, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7011252164 |
| Fax |
|
| Email |
piyusha@iihmr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Piyusha Majumdar |
| Designation |
Associate Professor |
| Affiliation |
IIHMR University |
| Address |
IIHMR University
1 Prabhu Dayal Marg, Sanganer, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7011252164 |
| Fax |
|
| Email |
piyusha@iihmr.edu.in |
|
|
Source of Monetary or Material Support
|
| IIHMR University 1, Prabhu Dayal Marg, Near Sanganer Airport, Maruti Nagar, Jaipur, Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Kartavya Kumar Tiwari |
| Address |
1 Prabhu Dayal Marg, Sanganer, Jaipur, Rajasthan, 302029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kartavya Kumar Tiwari |
Integrated Disease Surveillance Program Unit, District Office |
Room No. 1, Integrated Disease Surveillance Program Unit, District Office, IPP-06 Campus, District Dewas, Madhya Pradesh 455001
Dewas
MADHYA PRADESH |
9109682588
kartavya.phd9@iihmr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, IIHMR University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health seeking behavior of Female Sex Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Individuals who identify as female and are 18 years to 60 years, currently residing in Dewas district, Madhya Pradesh, and who have engaged in sex work at least once in the past 30 days, either on a full-time or part-time basis. The study will include both registered and non-registered Female Sex Workers (FSWs), in recognition of the diversity of typologies and operational patterns within the local sex work community. Participants must be able to understand and respond in Hindi and must be willing to provide verbal and/or written informed consent. |
|
| ExclusionCriteria |
| Details |
Individuals who do not identify as female, are under the age of 18, do not reside in Dewas district, or have not engaged in sex work during the defined recall period. Additionally, individuals who are unable or unwilling to provide informed consent, or who have severe cognitive or mental health impairments that would limit their ability to understand or participate meaningfully in the study, will not be eligible. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life of Female Sex Workers in Dewas |
Baseline (3 Months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/09/2025 |
| 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="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
|
This cross-sectional, mixed-methods study aims to investigate the quality of life, healthcare-seeking behavior, and patterns of service utilization among Female Sex Workers (FSWs) in Dewas district, Madhya Pradesh. The quantitative component will involve structured surveys to capture socio-demographic characteristics, lifestyle behaviors, physical and mental well-being, and access to health services. The qualitative component will include in-depth interviews with both FSWs and key stakeholders—such as outreach workers, counselors, medical officers, and program managers—to examine contextual and institutional barriers to service delivery. The study seeks to generate comprehensive, evidence-based insights to inform policy, enhance targeted interventions, and improve health and health outcomes for FSWs. |