Globally, 41% of all pregnancies are unintended, increasing risk for maternal and infant morbidities and mortality. Most unintended pregnancies occur in the context of contraceptive non-use or failure. Women with husbands 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. Such findings high- light the need for family planning (FP) interventions that engage both women and men, focus on eliminat- ing marital sexual violence (MSV) and promote use of effective (low failure risk) spacing contraception in- cluding long-acting reversible contraception (LARC; e.g. intrauterine device or IUD). Rural India, with some of the lowest rates of contraception and highest rates of marital violence globally, offers an im- portant context in which 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 three months. This intervention improved contraceptive use and reduced likelihood of MSV, but demonstrated no reduction in unintended pregnancy; additionally, it demonstrated good 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 (pill, condom) more vulnerable to contraceptive failure, likely compromised unintended pregnancy out- comes. Based on these findings, we propose CHARM2, which will include CHARM sessions for men AND parallel women-focused GE+FP sessions delivered by a female provider and inclusive of broader contra- ceptive 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 poten- tial for sustainability in rural India, using implementation science methods. To evaluate the impact of CHARM2 on our outcomes of interest, a two armed cluster randomized controlled trial will be conducted with N=1000 married couples from 50 geographic clusters (n=20 couples per cluster) in rural Maharash- tra, India. Participants will receive CHARM2 or the standard of care control condition, 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 and 9&18-month follow-ups. Implementation science methods will be used to assess the quality, scalability, and replicability of CHARM2 for uptake by rural health care systems (i.e., sustainability). Specifically, in-depth interviews will be conducted with CHARM2 intervention couples (n=50) and providers (n=20); focus groups will be conducted with key stakeholders from the family planning and rural health infrastructures at state, national and international levels (n=50), and we will implement a cost-effectiveness analysis of CHARM2.

Public Health Relevance

This study aims to implement and evaluate CHARM2, a gender equity (GE) focused family planning (FP) intervention for couples. CHARM2 involves sex-matched health providers offering GE+FP counseling, for men and women in parallel; women?s sessions will include provision of a basket of contraceptive options, including long acting reversible contraceptives (LARC), and condoms will be provided in men?s sessions. A two armed-cluster randomized controlled trial will assess the impact of CHARM2 on contraceptive use, unintended pregnancy, and marital sexual violence over an 18 month follow-up period; implementation science research, including interviews with CHARM2 participants and stakeholders as well as a cost- effectiveness analysis, will be used to assess the acceptability, replicability and sustainability of the CHARM2 intervention.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Social Psychology, Personality and Interpersonal Processes Study Section (SPIP)
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King, Rosalind B
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University of California, San Diego
Internal Medicine/Medicine
Schools of Medicine
La Jolla
United States
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