Udaan: scaling up health system response to and prevention of domestic violence: Protocol of a cluster randomised trial

Violence against women is a public health problem, a gender inequality issue, and a human rights violation. WHO’s Clinical and Policy Guidelines on Responding to intimate partner violence and sexual violence against women (2013) recommends integration of response to violence against women in primary healthcare services. However, there are several gaps in understanding how integration of these Guidelines can be achieved in low- and middle-income country settings, in particular at primary healthcare level and including community health workers in preventing violence. This manuscript describes a protocol for a study which aims to integrate violence against women response and prevention in primary healthcare services by strengthening health systems, including training health workers in Maharashtra, India. The study is a cluster – randomised controlled trial using randomized block design to examine both the effectiveness of the intervention in reducing domestic violence and testing the strategies to implement the intervention. The intervention activities including capacity building of health workers and community health workers, and other elements of health systems strengthening including improving patient flow for privacy and confidentiality, establishing protocols, documenting cases and strengthening referral mechanisms. The intervention will be implemented in two randomly selected blocks in Chhatrapati Sambhajinagar district of Maharashtra, India. A cross- sectional survey to assess reduction in domestic violence will be carried out among women visiting health facilities in intervention and control arm at baseline and end line (i.e. after 18 months). The effectiveness of capacity building of health workers and community health workers, and system strengthening activities, will be assessed by a knowledge, attitude and practice survey and facility readiness assessment respectively. In- depth interviews and focus group discussions will be carried out with health workers to understand their perceptions about relevance and experience of implementing the intervention. The study will also employ methodology to establish the cost of this health system response to domestic violence. The proposed study will build understanding on the integration of violence against women responses at the primary health system level. The findings will be helpful in operationalizing the policy and legal mandate of healthcare providers to respond to domestic violence in the Indian context. Further, we will obtain evidence on what is required at the level of the health system, including the role of community health workers to prevent domestic violence. The trial is registered with Clinical Trial Registry of India which is government of India’s official trial registry. The trial registration number is CTRI/2024/07/071367. It was registered on 26th July, 2024. ( https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTEwNTAw&Enc=&userName= ). The protocol is Version 1, dated July 26, 2024. The trial is registered on ClinicalTrials.gov, CTRI/2024/07/071367, with public title Health system response to violence against women. The enrolment was on October, 1st, 2024. The trial is currently recruiting participants.