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CTRI Number  CTRI/2024/07/071367 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Health system response to violence against women 
Scientific Title of Study   Scaling up health system response to and prevention of violence against women in primary health care settings: A cluster randomised trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjida Arora 
Designation  Senior research officer 
Affiliation  Centre For Enquiry Into Health and Allied Themes 
Address  A103 B103 First Floor Moniz Tower Yeshwant Nagar Road Vakola Santacruz East Mumbai

Mumbai
MAHARASHTRA
400055
India 
Phone  8976552582  
Fax    
Email  sanjida@cehat.org  
 
Details of Contact Person
Scientific Query
 
Name  Sanjida Arora 
Designation  Senior research officer 
Affiliation  Centre For Enquiry Into Health and Allied Themes 
Address  A103 B103 First Floor Moniz Tower Yeshwant Nagar Road Vakola Santacruz East Mumbai

Mumbai
MAHARASHTRA
400055
India 
Phone  8976552582  
Fax    
Email  sanjida@cehat.org  
 
Details of Contact Person
Public Query
 
Name  Sanjida Arora 
Designation  Senior research officer 
Affiliation  Centre For Enquiry Into Health and Allied Themes 
Address  A103 B103 First Floor Moniz Tower Yeshwant Nagar Road Vakola Santacruz East Mumbai

Mumbai
MAHARASHTRA
400055
India 
Phone  8976552582  
Fax    
Email  sanjida@cehat.org  
 
Source of Monetary or Material Support  
District health office zilla Parishad in front Of Amba Apsara Cinema Theater, Aurangpura - Samarthnagar Rd, Swatantrya Sainik Colony, Aurangpura, Aurangabad, Maharashtra 431001 
 
Primary Sponsor  
Name  Foreign Commonwealth and Development Office FCDO 
Address  iHUB Merchant Square 3rd Floor Block C Riverside Drive PO Box 62727 Nairobi Kenya 
Type of Sponsor  Other [UK governments agency funding a seven year program gloablly in various low- middle income countries] 
 
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 
Sanjida Arora  Primary health centres  Gangapur, Paithan, Kannad and Vaijapur
Aurangabad
MAHARASHTRA 
8976552582

sanjida@cehat.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Anusandhant Trust  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Domestic violence 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No intervention  No intervention. 
Intervention  Strengthening the health systems response to domestic violence.   The core intervention is the implementation of the WHO, Clinical and Policy Guidelines, 2013 on responding to intimate partner violence. The intervention components are organized according to the WHO health systems building blocks: Strengthen the health work force capacity: This will include training, supervision and mentoring of healthcare providers on health response to domestic violence. adapted per context. The training will focus on VAW as a health problem; gender attitudes; and clinical skills of HCPs in identifying women subjected to violence and offering first-line support. Strengthen inter-sectoral coordination: Health facilities will be equipped to make referrals including from primary to secondary and tertiary facilities and from secondary to tertiary facilities, and to local women’s groups, NGOs, one-stop crisis centres, police stations, shelters, child welfare committees, and protection officers through updated directory of referrals. Responsible officers will be appointed for proactive referral follow up and inter-sectoral coordination, to promote active engagement and cross-learnings across support services for survivors. Strengthen governance/leadership, accountability: Champions will be created from among administrative heads of health services and senior clinicians. They will be selected based on criteria of having supervisory and mentoring role, decision-making responsibilities, and willingness to give time to mentoring HCPs, and given additional training on how to mentor and advocate for a health system response to VAW Improve service delivery: Establishment of written SOPs/protocols documenting the importance and mechanisms to ensure for privacy, confidentiality, referrals and clinical management pathways. The clinical management pathways will specify ways to improve continuum of care for survivors including through referrals at different service delivery levels. Improve health infrastructure: This will entail discussion with health facility managers on identifying spaces where consultations can take place with visual and auditory privacy. If such spaces are not available, discussions with managers will involve what can be done to create such spaces within their existing resources and only if that is not possible, then additional resource requirements will be explored. Improve collection of data for monitoring and evaluation: Facility registers with a one-page intake form will be introduced as part of the health management information systems. HCPs will be trained to document cases of violence identified and managed, and data will be aggregated on women’s uptake of services quarterly through intake forms in facility registers. Training of healthcare providers will be for two days at baseline. This will be followed up by a one day refresher training at 9 months. Health system strengthening activities will be carried for 18 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Adult women (18 and older) attending health facilities will be interviewed at baseline and endline through two cross-sectional surveys to assess their experiences with domestic violence.  
 
ExclusionCriteria 
Details  Age: Below 18
Sex: Males
Women will not be included in the study if they have a cognitive disability that would preclude them from understanding the informed consent process
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in prevalence of domestic violence among women attending health facilities.  Baseline (0) and Endline (18 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in different forms of domestic violence including physical, emotional and financial.  Baseline (0) and Endline (18 months) 
 
Target Sample Size   Total Sample Size="9804"
Sample Size from India="9804" 
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)   01/10/2024 
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="1"
Months="6"
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 overall purpose of the study is to improve quality of care for women who have been subjected to domestic violence, and to reduce such violence. The aim of this implementation research study is to test the effectiveness of approaches being used to in improving health care response to VAW at the primary health care level in low- and middle- income country (LMIC) settings and to test the efficacy of a health system prevention intervention (through community health workers (CHWs)) on reducing prevalence of domestic violence.

The six specific primary objectives are written below:

1)      Determine what factors lead to improvements in HCPs and community health workers (CHWs) skills and clinical practice in identifying and responding to women survivors of domestic violence and/or preventing domestic violence.

2)      Identify which factors lead to improvements in health facility readiness to deliver care to women survivors of violence.

3)      Explore the influence of health systems interventions and community outreach intervention for on uptake of services and women’s perceptions of quality of care.

4)      Establish a costing of the health intervention to respond to domestic violence. 

5)      Identify the most relevant questions/ items to measure changes in HCPs’ and CHWs’ knowledge, attitudes practices/skills and in health facility readiness.

6)      Test the efficacy of a combined CHWs and health systems strengthening intervention on reducing domestic violence.

 

This protocol corresponds to the objective of testing the efficacy of community health workers and health systems strengthening intervention in reducing domestic violence among women accessing health facilities.

 

To address this objective, a questionnaire measuring the past 6-month prevalence of domestic violence (physical, sexual, and emotional) will be asked at baseline and end line (18 months) to adult women (18 and older) seeking health services at the facilities in the intervention and control arm. The survey will measure basic demographics as well as ask questions on physical, sexual and emotional violence drawing from validated scales on women’s health and domestic violence updated questionnaire. Respondents will not be tracked across time, instead the survey will be administered as two cross-sectional surveys whereby each wave of data collection will include its own standalone survey of clinic-attending women. Surveys will be conducted in private and participants will be recruited by researchers stationed at the waiting rooms of the health facilities with a focus on adult women coming to ante-natal care (ANC) and general outpatient departments (OPD). While waiting to be seen by HCPs, women will be asked if they consent to participate in the study with detailed information given about how the data will kept confidential. No personally identifiable information will be asked. Researchers will let participants know that they are free to decide whether or not they wish to be surveyed and this decision will not influence the care they receive. Survivors will be excluded from the study if the researcher determines that the survivor has limited capacity to understand the informed consent process, or if they are below 18 years of age.

 

 
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