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Clinical Trials/CTRI/2024/07/071367
CTRI/2024/07/071367
Not yet recruiting
Not Applicable

Scaling up health system response to and prevention of violence against women in primary health care settings: A cluster randomised trial.

Foreign Commonwealth and Development Office FCDO1 site in 1 country9,804 target enrollmentStarted: October 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Foreign Commonwealth and Development Office FCDO
Enrollment
9,804
Locations
1
Primary Endpoint
Decrease in prevalence of domestic violence among women attending health facilities.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Decrease in prevalence of domestic violence among women attending health facilities.

Time Frame: Baseline (0) and Endline (18 months)

Secondary Outcomes

  • Decrease in different forms of domestic violence including physical, emotional and financial.(Baseline (0) and Endline (18 months))

Investigators

Sponsor
Foreign Commonwealth and Development Office FCDO
Sponsor Class
Other [UK governments agency funding a seven year program gloablly in various low- middle income countries]
Responsible Party
Principal Investigator
Principal Investigator

Sanjida Arora

Centre For Enquiry Into Health and Allied Themes

Study Sites (1)

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