Gender Equity-Focused, Male-Centered Family Planning for Rural India
Condition: Family Planning
Study type: Interventional
Phase: Phase 3

Summary: 
      The major barrier to India meeting its national goal of replacement fertility is the huge
      discrepancy between urban and rural family planning, with rural young women at highest risk
      for unplanned and unspaced pregnancies. These concerns are considered to drive the persistent
      and unacceptably high rates of maternal and infant mortality in India. Major impediments to
      these young wives' acquisition of family planning services include high male partner control
      over reproductive decision-making, low mobility, and very low access to family planning
      services in villages. Such findings document the need for male-centered family planning
      efforts available at the village level, to better meet the needs of rural young wives. These
      male-centered efforts must address male gender role and gender inequity ideologies and norms
      (e.g., son preference, wife abuse) and marital communication, as these factors are associated
      with lower likelihood of contraceptive use in rural young Indian couples. Hence, the proposed
      study involves development and testing of the CHARM Program, a gender equity (GE)-focused,
      male-centered family planning (FP) program delivered by village health providers (VHPs), via
      a public-private partnership with primary health centers (PHCs) and private providers serving
      rural India. In Phase 1 the investigators will conduct formative research including health
      care resource mapping of Vasai within the Thane district of Maharashtra to identify villages
      and VHPs for inclusion in subsequent research and intervention. The investigators will also
      conduct in-depth interviews with rural young husbands (n=30), rural young wives (n=20), and
      health care providers (n=12), as well as focus groups with mothers' of rural young husbands
      (n=40). These data will be used to develop the CHARM program and efficacy trial. Phase 2 will
      involve development and pilot testing of CHARM protocols and training of VHPs for their role
      in the intervention trial (Phase 3). The CHARM intervention will involve VHP-delivered GE and
      FP counseling. It is delivered via a single session with 2 optional additional sessions one
      of which would include their wife. Phase 3 will involve evaluation of CHARM, using a
      two-armed randomized controlled trial design. Villages (N=50) will be randomized to receive
      either CHARM or the control program (standard FP referral to government public health centers
      [PHCs] located outside of villages), to assess treatment impact on spacing contraceptive use,
      pregnancy, and unmet family planning need. Intervention effects will be assessed via
      behavioral surveys with rural young husbands (18-30 years) and their wives (N=1000 couples,
      20 couples per village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests
      from wives, conducted at baseline and 18 month follow-up. A process evaluation will be
      undertaken via interviews with study participants and VHPs, as well as through VHP interviews
      and clinical record review, to assess program adherence, participation rates, response to
      program, and ease of delivery. In-depth interviews will also be conducted with key informants
      from the village and public and rural health systems to assess sustainability and
      institutionalization of the model.
    


Intervention name(s): CHARM
Intervention type(s): Behavioral
Intervention description(s): CHARM will be conducted via three 30-minute counseling sessions delivered in the rural setting, with the first session required and the 2nd and 3rd sessions optional. The first two CHARM sessions will be for men only to build family planning (FP) and gender equity (GE) awareness and investment, and the third session will be for the couple with an emphasis on FP services, shared decision-making and marital communication. The three sessions can occur anytime within a 3 month timeframe but with a minimum of 1 week between sessions. All sessions and FP services (pill, condom, EC) will be provided at no cost to patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: contraception; india; rural