Dil Mil (Hearts Together)
Condition: Gender Based Violence; Women's Health
Study type: Interventional
Phase: Phase 2

Summary: 
      A growing body of research indicates that gender-based violence (GBV) is a major global
      public health challenge. Yet, there is a dearth of evidence to guide program planning and
      policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and
      potential effectiveness of an innovative women's empowerment intervention to reduce GBV and
      related adverse health outcomes. It is expected that the study findings will provide evidence
      to determine if a phase 3 effectiveness trial is merited and advance the science underlying
      GBV prevention.
    

Detailed description: 
      The prevalence of physical, psychological, and sexual gender-based violence (GBV) is
      staggeringly high among young, married women in India. However, few GBV prevention
      interventions have been implemented, and none of these interventions has been rigorously
      evaluated. The investigators aim to fill this gap by conducting exploratory research on an
      innovative women's empowerment-based GBV prevention intervention. The proposed study builds
      on our previous research in urban poor communities in Bangalore, India, which revealed that
      efforts to enhance young, married women's power and to mitigate GBV will be limited if the
      broader context of their lives, which is shaped mainly by the marital family, is unaddressed.
      Previous research suggests that mothers-in-law (MILs) are a strategic familial entry point
      and that it may be possible to redirect the power they wield in the family toward reducing
      GBV against daughters-in-law (DILs). Based on this evidence and women's empowerment
      approaches that have successfully reduced GBV elsewhere, the investigators developed the
      intervention Dil Mil (meaning "Hearts Together" in India's national language, Hindi).

      Guided by the Social Cognitive Theory and Heise's social-ecological framework of GBV, Dil Mil
      aims to empower DIL-MIL dyads with knowledge, skills, and social support critical to the
      mitigation of GBV and related adverse health outcomes among DILs. The investigators chose
      antenatal care as the context for implementing this intervention because of women's nearly
      universal use of antenatal care in urban India. A phase 1 pilot study demonstrated that our
      approach is acceptable and likely to be safe. The aim of this R21 is to conduct a phase 2
      trial to examine the feasibility, safety, and potential effectiveness of Dil Mil in order to
      determine if a phase 3 effectiveness trial is merited.

      The proposed study is a randomized controlled trial with 140 dyads comprising pregnant DILs
      (aged 18 to 30 years, in their first or second trimester of pregnancy, with a history of GBV)
      and their MILs. Recruitment will take place at four primary health centers serving poor
      communities in Bangalore. Dyads will be offered standard care or standard care plus the Dil
      Mil intervention, and evaluations will be conducted at 3 months and 6 months postpartum. The
      investigators will characterize the study population using descriptive statistics and assess
      feasibility and safety of the intervention using qualitative and quantitative data (Aim 1).
      Data on the effect of the intervention on intermediary outcomes-the empowerment of DILs and
      MILs (Aim 2)-and on the incidence of GBV among DILs during the first 6 months postpartum,
      DILs' perceived quality of life and psychosocial status, and maternal and infant health
      outcomes (Aim 3) will be analyzed using the intention-to-treat principle. Based on this
      evidence, the investigators will determine if a phase 3 trial is merited. In conclusion, this
      study will generate important insights on a novel, urgently needed response to GBV in a high
      prevalence setting and is highly likely to have a significant public health impact.
    

Intervention name(s): Primary care for Daughters-in-Law; The Dil Mil Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced GBV.A comprehensive health examination for MILs will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks.; The Dil Mil intervention will be implemented during the second and third trimesters of the DILs' pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with MILs, and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. Participants are encouraged to critically analyze their relationships and to develop and implement responses appropriate to their families and communities. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce GBV and protect and promote their family's health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gender based violence; maternal and child health; women; India