Several researchers have described their attempts at applying the WHO’s guidelines in LMIC contexts. The WHO guidelines emphasized the importance of promoting respondent and interviewer safety (for example, by ensuring privacy during interviews and interviewing only one woman in each household), careful training of research staff to ask questions and respond to disclosures about DV, offering referrals to critical support services (e.g., including a counselor or consultant on the study team, linking to a local counseling center, providing a directory of referrals services), and ensuring that evidence is used to advance policy and program development.
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Over a decade ago, the World Health Organization (WHO) issued its recommendations on ethics and safety in research on domestic violence against women. This is especially the case for research on interventions to prevent and/or mitigate DV.
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However, there is little guidance regarding how best to promote safety of participants enrolled in these studies – including how to define, track and monitor safety risks and adverse events. Randomized controlled trials of social and behavioral interventions are growing in number.
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In this paper we describe the design of a randomized controlled trial of an intervention to mitigate DV and related adverse health consequences in antenatal care settings in urban Bengaluru, India, focusing on the strategies used to address ethical challenges in research implementation. However, relatively little research has been conducted on interventions with the potential to mitigate DV and its adverse health consequences, and few resources exist to guide safety planning and monitoring in the context of intervention research. Data will be analyzed to examine the feasibility and safety of the intervention and the effect of the intervention on intermediary outcomes (the empowerment of daughters-in-law and mothers-in-law), incidence of domestic violence among daughters-in-law, and health outcomes including perceived quality of life, psychosocial status and maternal and infant health outcomes.Ī large number of studies have documented the occurrence of domestic violence (DV) - physical, psychological, or sexual abuse perpetrated against women by one or more family members - globally and in low- and middle income country (LMIC) settings such as India. Additional evaluations will be conducted at 3 months and 6 months postpartum.
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Once enrolled, dyads will participate in a baseline interview and then randomized either to the control arm and receive standard care or to the intervention arm and receive standard care plus the Dil Mil intervention. If eligible and willing, their mother-in-law will also be recruited. Young pregnant women in the first or second trimester of pregnancy will be recruited from antenatal services at study health centers and through community outreach. A phase 2 randomized controlled trial using a parallel comparison of the Dil Mil intervention versus standard care will be implemented in three public primary health centers in Bengaluru.