Evaluation of a gender synchronized family planning intervention for married couples in rural India: The CHARM2 cluster randomized control trial

BACKGROUND: Despite calls for gender transformative family planning interventions to increase male engagement and female reproductive agency, there is limited research involving rigorous evaluation of the integration of these approaches. CHARM2 (counseling Husbands and wives to Achieve Reproductive Health and Marital Equity) builds upon a prior three-session male engagement intervention by integrating female-focused sessions emphasizing women's choice and agency (i.e., gender synchronization). We hypothesized that CHARM2 participants will be more likely to report marital contraceptive use and communication and women's contraceptive agency, and less likely to report unintended pregnancy, relative to participants in the control condition. METHODS: We conducted a two-armed cluster randomized controlled trial evaluating the effects of CHARM2 on marital contraceptive use, communication, decision-making; women's contraceptive agency, and pregnancy among young married couples in rural Maharashtra, India (ClinicalTrials.gov #NCT03514914, complete). 40 geographic clusters, defined based on the catchment areas of subcenter health facilities (the most proximal level of community health care within India's public health system) were randomized to control (n = 20) and intervention (n = 20). We assigned all participants within that geographic cluster to the corresponding cluster treatment condition; participants, investigators, and study staff were not masked to treatment assignment. Eligibility criteria included wife aged 18–29, couple residing together for at least six months with no plan for migration, and neither spouse sterilized or infertile. The CHARM2 intervention included five provider-delivered sessions on gender equity and family planning, two delivered in parallel to husbands and wives separately by gender-matched providers, and one final joint session, delivered within the four months subsequent to baseline survey. We conducted surveys and pregnancy testing at baseline and 9-month and 18-month follow-up. We used difference-in-differences multilevel mixed effects logistic regressions to assess CHARM2 effects on marital contraceptive use and communication, and women's contraceptive agency; we used single time point mixed effects logistic regressions for pregnancy outcomes. All analyses used an intention-to-treat approach. FINDINGS: 1201 couples were recruited between September 2018 and June 2019; 600 intervention and 601 control. All couples were included in outcome analyses. Full couple retention was 90·2% (n = 1083) at 9-month follow-up and 90·5% (n = 1087) at 18-month follow-up. Modern contraceptive use was higher among intervention participants at 9-month but not 18-month follow-up (9-month adjusted ratio of odds ratio [AROR] 1·5, 95% CI 1·03–2·3; 18-month AROR 0·8, 95% CI 0·4–1·4). Communication (9-month AROR 1·9, 95% CI 1·0–3·6; 18-month AROR 2·7, 95% CI 1·5–4·8) and agency (9-month AROR 5·1, 95% CI 1·2–22·4; 18-month AROR 8·1, 95% CI 1·4–48·2) both improved at both time points. There was no significant difference in pregnancy between groups over the 18-month period (AOR 0·8, 95% CI 0·7–1.1) However, for women who expressed fertility ambivalence at baseline, unintended pregnancy was marginally less likely among intervention participants (47% vs 19%) (p = 0·07). There were no reported adverse events. INTERPRETATION: The CHARM2 intervention offers a scalable model to improve contraceptive use, communication, and agency and possibly decrease unplanned pregnancies for couples in rural India.