CHARM, a gender equity and family planning intervention for men and couples in rural India: protocol for the cluster randomized controlled trial evaluation.

BackgroundGlobally, 41% of all pregnancies are unintended, increasing risk for unsafe abortion, miscarriage and maternal and child morbidities and mortality. One in four pregnancies in India (3.3 million pregnancies, annually) are unintended; 2/3 of these occur in the context of no modern contraceptive use. In addition, no contraceptive use until desired number and sex composition of children is achieved remains a norm in India. Research shows that globally and in India, the youngest and most newly married wives are least likely to use contraception and most likely to report husband's exclusive family planning decision-making control, suggesting that male engagement and family planning support is important for this group. Thus, the Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention was developed in recognition of the need for more male engagement family planning models that include gender equity counseling and focus on spacing contraception use in rural India.Methods/designFor this study, a multi-session intervention delivered to men but inclusive of their wives was developed and evaluated as a two-armed cluster randomized controlled design study conducted across 50 mapped clusters in rural Maharashtra, India. Eligible rural young husbands and their wives (N = 1081) participated in a three session gender-equity focused family planning program delivered to the men (Sessions 1 and 2) and their wives (Session 3) by village health providers in rural India. Survey assessments were conducted at baseline and 9&18 month follow-ups with eligible men and their wives, and pregnancy tests were obtained from wives at baseline and 18-month follow-up. Additional in-depth understanding of how intervention impact occurred was assessed via in-depth interviews at 18 month follow-up with VHPs and a subsample of couples (n = 50, 2 couples per intervention cluster). Process evaluation was conducted to collect feedback from husbands, wives, and VHPs on program quality and to ascertain whether program elements were implemented according to curriculum protocols. Fidelity to intervention protocol was assessed via review of clinical records.DiscussionAll study procedures were completed in February 2015. Findings from this work offer important contributions to the growing field of male engagement in family planning, globally.Trial registrationClinicalTrial.gov, NCT01593943

A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

BackgroundPrior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE + FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra.MethodsA two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE + FP intervention. Eligible married couples (n = 1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE + FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples (n = 50) and providers (n = 20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys.DiscussionWe will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally.Trial registrationClinicalTrial.gov, NCT03514914

Factors affecting delayed and non-receipt of healthcare during the COVID-19 pandemic for women in rural Maharashtra, India:Evidence from a cross-sectional study

BACKGROUND: Pathways to low healthcare utilisation under the COVID-19 pandemic are not well understood. This study aims to understand women's concerns about the health system's priorities and their increased burden of domestic responsibilities during COVID-19 as predictors of delayed or non-receipt of needed care for themselves or their children. METHODS: We surveyed married women in rural Maharashtra, India (N = 1021) on their health and economic concerns between Feb 1 and March 26, 2021. This study period was when India emerged from the first wave of the pandemic, which had severely impacted the health systems, and before the second—even more devastating wave had started. We captured if women were concerned about access to non-COVID health services due to healthcare being directed solely to COVID-19) (exposure 1) and whether their domestic responsibilities increased during the pandemic (exposure 2). Our outcomes included women's reports on whether they delayed healthcare seeking (secondary outcome and mediator) and whether they received healthcare for themselves or their children when needed (primary outcome). We conducted adjusted regression models on our predictor variables with each outcome and assessed the mediation effects of delayed healthcare seeking for each of the exposure variables. FINDINGS: We found that women who were concerned that healthcare was directed solely towards COVID-19 were more likely not to receive healthcare when needed (Adjusted Risk Ratio [ARR] = 1.49, 95% CI = 1.14, 1.95). We also found that women whose domestic care burden increased under the pandemic were more likely to delay healthcare seeking (ARR = 1.84, 95% CI = 1.05, 3.21). Delayed healthcare seeking mediated the associations between each of our exposure variables with our outcome variable, non-receipt of needed healthcare. INTERPRETATION: Our findings suggested that women's perceptions of healthcare systems and their domestic labour burdens affected healthcare seeking during the pandemic in India, even before the second wave of COVID-19 incapacitated the health system. Support for women and health systems is needed to ensure healthcare uptake during crises. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, USA (grant numbers: R01HD084453- 01A1 and RO1HD61115); Department of Biotechnology, Government of India (grant #BT/IN/US/01/BD/2010); the EMERGE project (Bill and Melinda Gates Foundation Grants: OPP1163682 and INV018007; PI Anita Raj), and Bill and Melinda Gates Foundation Grant number INV-002967

Four-year follow-up of CHARM2, an effective family planning intervention, on number and sex of births: Findings from an RCT in rural India

Effective family planning interventions may have inadvertent effects on births of girls given son preference in India. We conducted 36 and 48-month follow-ups to our CHARM2 family planning study to determine long-term intervention effects on births and sex of children. Our non-blinded two-armed cluster RCT randomized young married couples (N = 1201 couples) from 20 geographic clusters (60-61 couples per cluster) into either the CHARM2 intervention or control (referral to local care) condition. CHARM2 offers 5-session gender-synchronized family planning and gender equity counseling delivered by trained local medical providers. Data were collected at baseline in September 2018-June 2019 and then follow-ups at 9, 18, 36 and 48 months, up to September 2023. We retained 88 %-91 % of women across follow-ups with no difference in retention by treatment group. We used adjusted mixed-effects logistic regression models examining sex composition of births at each follow-up and over the total 48-month follow-up to assess differences in all births of boys and girls by treatment group. We adjusted for treatment condition, cluster, and relevant demographics in adjusted models. We saw no treatment effects on total births or boy births, but lower likelihood of a girl birth was seen at 9-month follow-up and for the total 48-month follow-up period. We found at 9-month follow-up a girl birth was less likely for intervention compared with control participants (7.1 % vs. 10.3 %, respectively, p = 0.06), and the male to female sex ratio of births born between baseline and 9-month follow-up was also significantly higher for intervention vs. comparison participants (1.50 [95 % CI 1.00-2.26] vs. 0.83 [95 % CI 0.56-1.21], p = 0.04). We conducted a sensitivity analysis to determine treatment effects on boy births and girl births over the 48-month follow-up and again found no effects on boy births, but a significantly lower likelihood of a girl birth for the intervention group (22 % vs 29 %, p = 0.03). The CHARM2 family planning intervention, previously demonstrating significant effects on contraceptive use and women's reproductive agency in rural India, resulted in lower likelihood of girl births over time, suggesting that family planning programs can contribute to sex ratio imbalances if broader social changes eliminating son preference and improving value of a girl child do not occur. National Institutes of Health, Grant R01HD084453 Bill and Melinda Gates Foundation. INV002967. The funders had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. [ClinicalTrials.gov Identifier: NCT03514914.]

Assessing the impact of CHARM2, a family planning program on gender attitudes, intimate partner violence, reproductive coercion, and marital quality in India

Using a two-armed cluster randomised controlled trial, CHARM2 (Counselling Husbands to Achieve Reproductive health and Marital equity), a 5-session gender equity and family planning intervention for couples in rural India, showed an impact on family planning outcomes in primary trial analyses. This study examines its effects on gender-equitable attitudes, intimate partner violence, reproductive coercion, and marital quality. We used multilevel mixed-effects models to assess the intervention impact on each outcome. Both male (aIRR at 9 months: 0.64, C.I.: 0.45,0.90; aIRR at 18 months: 0.25, C.I.: 0.18,0.39) and female (aIRR at 9 months: 0.57, C.I.: 0.46,0.71; aIRR at 18 months: 0.38, C.I.: 0.23,0.61) intervention participants were less likely than corresponding control participants to endorse attitudes accepting physical IPV at 9- and 18-month follow-ups. Men in the intervention, compared to those in the control condition, reported more gender-equitable attitudes at 9- and 18 months (ß at 9 months: 0.13, C.I.: 0.06,0.20; ß at 18 months: 0.26, C.I.: 0.19,0.34) and higher marital quality at the 18-month follow-up (ß: 0.03, C.I.: 0.01,0.05). However, we found no effects on women’s experiences of IPV, reproductive coercion, or marital quality. CHARM2 shows promise in improving men’s and women’s attitudes towards gender equality and male perceptions of marital quality. Still, IPV and reproductive coercion reductions may require more intensive programming than that provided within this 5-session model focused on family planning

Validation of the Fertility Norms Scale and Association with Fertility Intention and Contraceptive Use in India.

Social norms related to fertility may be driving pregnancy desire, timing and contraceptive use, but measurement has lagged. We validated a 10-item injunctive Fertility Norms Scale (FNS) and examined its associations with family planning outcomes among 1021 women and 1020 men in India. FNS captured expectations around pronatalism, childbearing early in marriage and community pressure. We assessed reliability and construct validity through Cronbachs alpha and exploratory factor analysis (EFA) respectively, examining associations with childbearing intention and contraceptive use. FNS demonstrated good reliability (α = 0.65-0.71) and differing sub-constructs by gender. High fertility norm among women was associated with greater likelihood of pregnancy intention [RRR = 2.35 (95% CI: 1.25,4.39); ARRR = 1.53 (95% CI: 0.70,3.30)], lower likelihood of delaying pregnancy [RRR = 0.69 (95% CI: 0.50,0.96); ARRR = 0.72 (95% CI: 0.51,1.02)] and greater ambivalence on delaying pregnancy [RRR = 1.92 (95% CI: 1.18,3.14); ARRR = 1.99 (95% CI: 1.21,3.28)]. Womens higher FNS scores were also associated with higher sterilization [RRR = 2.17 (95% CI: 1.28,3.66); ARRR = 2.24 (95% CI: 1.32,3.83)], but the reverse was noted for men [RRR = 0.61 (95% CI: 0.36,1.04); ARRR = 0.54 (95% CI: 0.32,0.94)]. FNS indicated better predictive value among women compared to men for key reproductive outcomes. This measure may be useful for social norms-focused evaluations in family planning and warrants cross-contextual study

Examining the association between mens gender equitable attitudes and contraceptive outcomes in rural Maharashtra, India.

BACKGROUND: Previous literature suggests that men reporting more gender-equitable attitudes are more likely to use condoms, but there is a paucity of data evaluating whether these attitudes are associated with contraceptive communication and use. The objective of this study is to test the hypothesis that men reporting more gender-equitable attitudes will be more likely to (a) engage in contraceptive communication with their wives and (b) that they and/or their wives will be more likely to use all forms of family planning, compared to men with less equitable attitudes. METHODS: Using cross-sectional dyadic survey data from young married couples from rural Maharashtra, India (N = 989), we assessed the associations between mens gender role attitudes and a) spousal contraceptive communication and b) contraceptive use by type (none, traditional, condoms, pills, or IUD). The contraceptive use outcome is based on wives report. We assessed these associations via bivariate t-test (communication outcome) or ANOVA test (contraceptive type outcome), as well as unadjusted and adjusted logistic (communication outcome) and multinomial logistic (contraceptive type outcome) regression models. Adjusted models included sociodemographic factors selected a priori based on established associations with gender-equitable attitudes and/or our assessed outcomes. FINDINGS: Men with more gender-equitable attitudes were more likely to discuss family planning with their wives (AOR = 1·05, 95%CI 1·03-1·07, p < 0·001) and to use condoms (ARRR = 1·03, 95%CI 1·00-1·06, p = 0·07). There was no association between gender-equitable attitudes and use of other types of contraception. INTERPRETATION: While gender-equitable attitudes among men may facilitate condom use and family planning communication in marriage, they do not appear to be linked with greater likelihood of use of more effective types of contraceptive use. This suggests that males supportive of gender equity may take greater responsibility for family planning vis a vis a less effective contraceptive, condoms, in the absence of more effective short-acting contraceptives for men. FUNDING: The National Institutes of Health [Grant number 5R01HD084453-01A1] and the Bill & Melinda Gates Foundation, Seattle, WA [grant number INV-002967]

Spousal discordance on reports of contraceptive communication, contraceptive use, and ideal family size in rural India: a cross-sectional study

Background Persistent low rates of spacing contraceptive use among young wives in rural India have been implicated in ongoing negative maternal, infant and child health outcomes throughout the country. Gender inequity has been found to consistently predict low rates of contraception. An issue around contraceptive reporting however is that when reporting on contraceptive use, spouses in rural India often provide discordant reports. While discordant reports of contraceptive use potentially impede promotion of contraceptive use, little research has investigated the predictors of discordant reporting. Methods Using data we collected from 867 couples in rural Maharashtra India as part of a men-focused family planning randomized controlled trial. We categorized couples on discordance of men’s and women’s reports of current contraceptive use, communication with their spouse regarding contraception, and ideal family size, and assessed the levels of discordance for each category. We then ran multinomial regression analyses to determine predictors of discordance categories with a focus on women’s empowerment (household and fertility decision-making, women’s education, and women’s knowledge of contraception). Results When individuals reported communicating about contraception and their spouses did not, those individuals were also more likely to report using contraception when their spouses did not. Women’s empowerment was higher in couples in which both couples reported contraception communication or use or in couples in which only wives reported contraception communication or use. There were couple-level characteristics that predicted husbands reporting either contraception use or contraception communication when their wives did not: husband’s education, husband’s familiarity with contraception, and number of children. Conclusions Overall there were clear patterns to differential reporting. Associations with women’s empowerment and contraceptive communication and use suggest a strategy of women’s empowerment to improve reproductive health. Discordant women-only reports suggest that even when programs interact with empowered women, the inclusion of husbands is essential. Husband-only discordant reports highlight the characteristics of men who may be more receptive to family planning messages than are their wives. Family planning programs may be most effective when working with couples rather than just with women, and should focus on improving communication between couples, and supporting them in achieving concordance in their reproductive preferences. Trial registration Clinical Trials Number: NCT01593943, registered May 4, 2012 at clinicaltrials.gov

Understanding feasibility and acceptability of implementation of linking delivery of family planning and infant vaccination care in rural Maharashtra, India a qualitative study

Background Linking family planning with infant vaccination care has the potential to increase contraceptive use among postpartum women in rural settings. We explored the multilevel factors that can facilitate or impede uptake of contraception at the time of infant vaccination among postpartum women and couples in rural Maharashtra, India. Methods We conducted 60 semi-structured interviews with key stakeholders including: postpartum married women (n = 20), husbands (n = 10), and mothers-in-law (n = 10) of postpartum women, frontline healthcare workers (auxiliary nurse midwives (ANMs) and Accredited Social Health Activists (ASHAs), (n = 10), and community leaders (physician medical officers and village panchayat leaders) (n = 10). We sought to assess the feasibility and acceptability of delivering community-based postpartum family planning care in rural India at the time of infant vaccination. The Consolidated Framework for Implementation Research (CFIR) was used to design a structured interview guide and codebook. Data were analyzed via directed content analysis. Results Three major themes emerged: (1) Social fertility and gender norms including son preference and male control over contraceptive decision-making influence postpartum contraceptive access and choice. (2) Linking contraceptive care and infant vaccination is perceived as potentially feasible and acceptable to implement by families, health workers, and community leaders. The intervention provides care to women and families in a convenient way where they are in their community. (3) Barriers and facilitators to linked infant postpartum contraception and infant vaccination were identified across the five CFIR domains. Key barriers included limited staff and space (inner setting), and contraceptive method targets for clinics and financial incentives for clinicians who provide specific methods (outer setting). Key facilitators included convenience of timing and location for families (intervention characteristics), the opportunity to engage husbands in decision-making when they attend infant vaccination visits (participant characteristics), and programmatic support from governmental and community leaders (process of implementation). Conclusions Linked provision of family planning and infant vaccination care may be feasible and accessible in rural India utilizing strategies identified to reduce barriers and facilitate provision of care. A gender-transformative intervention that addresses gender and social norms has greater potential to impact reproductive autonomy and couples’ contraceptive decision-makin