Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy
Condition: Contraception
Study type: Interventional

Summary: 
      Globally, 41% of all pregnancies are unintended, increasing risk for maternal and infant
      morbidity and mortality. Most unintended pregnancies occur in the context of contraceptive
      non-use or failure. Women with husbands who are not supportive of contraception are more
      likely to report contraceptive non-use, and women with sexually abusive husbands are more
      likely to report contraceptive failure. This highlights the need for family planning (FP)
      interventions that engage both women and men, focus on eliminating marital sexual violence
      (MSV) and promote use of effective contraceptives including long-acting reversible
      contraception (LARC). Rural India, with some of the lowest rates of contraception and highest
      rates of marital violence globally, offers an important context to test such interventions,
      with global implications. Prior research from this team documents promise of the original
      CHARM intervention, a gender equity (GE) FP intervention engaging men and delivered by male
      health providers over 3 months. This intervention improved contraceptive use and reduced
      likelihood of MSV, but demonstrated no reduction in unintended pregnancy; additionally, it
      demonstrated high participation from men (91%) but less from couples (51%), largely due to
      women's discomfort with a male provider. Poor reach to women and provision of only
      short-acting contraceptives, more vulnerable to contraceptive failure, may have compromised
      an effect on unintended pregnancy outcomes. Based on these findings, CHARM2 includes CHARM
      sessions for men AND parallel women-focused GE+FP sessions delivered by a female provider and
      inclusive of broader contraceptive options, including LARC. This study seeks a) to implement
      CHARM2, b) to evaluate its impact on contraceptive use, unintended pregnancy, and MSV with
      rural couples in India, and c) to assess its potential for sustainability in rural India,
      using implementation science methods.

      To evaluate the impact of CHARM2, a 2-armed cluster randomized controlled trial will be
      conducted with up to N=1200 married couples from 20 geographic clusters (n=50-60 couples per
      cluster) in rural India. Participants will receive CHARM2 or the standard of care, which will
      involve community health workers offering pills/condoms and linking women to public health
      clinics. Outcomes will be assessed via pregnancy testing and surveys at baseline, 9 &
      18-month follow-ups. Implementation science methods will assess the quality, scalability, and
      replicability of CHARM2 for uptake by rural health care systems (i.e., sustainability).
    

Detailed description: 
      Overview: This study will involve 3 phases: Phase 1- the Preparatory Phase to map the project
      area and prepare communities for the planned research. Phase 2- Implementation and Evaluation
      of CHARM 2 (Aims 1&2), using a two-armed cluster randomized controlled trial (RCT) in 20
      geographic clusters mapped in Phase 1. To assess treatment impact on contraceptive use, MSV
      and unintended pregnancy, clusters will be randomized to receive CHARM2 or the control
      program, which includes standard of care public health FP services. Intervention effects will
      be assessed via surveys and pregnancy testing at baseline and 9 &18-month follow-up with
      n=1000-1200 couples (wife aged 18-29 years). Phase 3- Implementation Science Assessments will
      include in-depth interviews with CHARM2 providers (n=20), select CHARM2 couples (n=50) and
      key Indian stakeholders in FP & public health (n=50). Interviews with providers and couples
      will explore intervention delivery and perceived impact. Interviews with FP & public health
      stakeholders will obtain feedback on perceived feasibility to sustain and scale up CHARM2. A
      cost-effectiveness analysis will also be done to support considerations of sustainability.

      Intervention: The CHARM2 intervention will involve gender, culture and contextually-tailored
      FP+GE counseling sessions delivered individually to husbands by a trained male health
      provider (2 sessions), and, in parallel, delivered individually to wives by a trained female
      provider (2 session2). CHARM2 differs from the original CHARM intervention by 1.) eliminating
      the couple session 2.) adding a parallel component for wives, delivered by a female and
      inclusive of reproductive coercion counseling 3.) including LARC counseling for husbands and
      wives and LARC provision via the public health system.

      Standard of Care (Control): Under India's public health system, frontline health workers,
      including nurses, provide household visits to women to increase awareness and use of FP
      services but they rarely providing contraceptives. For those women or couples that reach the
      health center, standard of care FP counseling and services are delivered by a physician; free
      contraceptives are then offered.

      Timeline: Phase 1 of the study preparation will take approximately 3 months. Phase 2 will be
      in month 4 to month 60, including enrollment and intervention start at month 4, 9 month
      follow up at month 13, and a 18 month follow up at month 22. The outcome analysis will also
      be carried out in this phase at month 40. Phase 3, on sustaining the intervention will
      overlap from month 7 to month 60.

      Plan for Data Collection: All survey data will be collected using mobile devices (tablets)
      with an ODK-based software system for e-data collection and web-based data management. The
      ODK application with CHARM2 survey questionnaire will be loaded onto the tablets, displaying
      questions simultaneously in English and Marathi.
    

Intervention name(s): The CHARM2 Intervention
Intervention type(s): Behavioral
Intervention description(s): CHARM2 intervention will involve gender, culture & contextually-tailored family planning and gender equity counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the impact of CHARM2 on reversible contraceptive use (including LARC), unintended pregnancy, and MSV via a two armed cluster RCT with N=1000-1200 married couples from 20 geographic clusters (n=50-60 couples per cluster) in rural India. The control arm will receive standard of care in the form of community health workers offering pills/condoms and linking women to public health clinics.
Masking: None (Open Label)
Primary purpose: Other
Keywords: LARC, contraception, family planning, India, male engagement