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
|
|
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
|
|
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.
|