| Literature DB >> 35274093 |
Anita Raj1,2, Mohan Ghule1, Nicole E Johns1, Madhusudana Battala3, Shahina Begum4, Anvita Dixit1,5, Florin Vaida1,6, Niranjan Saggurti3, Jay G Silverman1, Sarah Averbach1,7.
Abstract
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.Entities:
Keywords: Cluster randomized controlled trial; Contraceptive use; Family planning; Gender equity
Year: 2022 PMID: 35274093 PMCID: PMC8902598 DOI: 10.1016/j.eclinm.2022.101334
Source DB: PubMed Journal: EClinicalMedicine ISSN: 2589-5370
Outcome measure definitions.
| Construct | Outcome | Definition |
|---|---|---|
| Modern contraceptive use | Any modern use | We asked participants whether they had done anything to prevent or delay a pregnancy within the past three months. If they answered ‘yes’, they were asked which method(s) they had used. Modern methods available in the project area were condoms (male condoms are widely available and there is limited availability of female condoms), combined hormonal and progestin-only oral contraceptive pills, Copper IUDs, emergency contraceptive pills, and sterilization (male and female). Injectable contraceptives were available in a limited number of locations. We excluded currently pregnant women from this outcome. We categorized participants as using a modern method in the past three months or not. Lactational amenorrhea (LAM) was not included as a modern method, per prior research. |
| Use by type | The categorical method type outcome included no method use in past three months, rhythm and/or withdrawal use only, condom use, pill use, IUD use, or (at 9-month and 18-month follow-up only) female sterilization use. We excluded currently pregnant women from this outcome. We excluded women exclusively using LAM, emergency contraceptives, and injectable contraceptives from this outcome due to low prevalence ( | |
| Male engagement in contraceptive use | Contraceptive communication | We assessed contraceptive communication by asking women “Did you have a discussion with your husband on contraceptive use in the past three months?”, with response options yes/no. |
| Joint decision-making | We assessed male engagement in contraceptive decision-making via the DHS India measure | |
| Contraceptive agency | Self-efficacy items 1, 2, & 3 | We used three distinct items to assess wife's contraceptive self-efficacy; these were kept as independent variables rather than combined into a scale due to insufficient intercorrelation. The items were: “How sure are you that you could tell your husband that you wanted to use family planning?”, “How sure are you that you could use family planning?”, and “How sure are you that you could use family planning, even if your husband did not want to?”, with response options ranging from 1 (completely unsure that I could) to 5 (completely sure that I could). Responses to all three items were highly skewed, so we dichotomized responses to completely/somewhat sure (4 or 5) vs not (1, 2, or 3). |
| Decision-making control | We used a single item to assess women's equal control with husband over contraceptive decision-making. We asked: “In the past three months, did you feel that you had equal right (as your husband) to choose a family planning method?” with response options yes/no. | |
| Pregnancy | Any pregnancy | At both 9-month and 18-month follow-up, we asked women if they were currently pregnant and how many times they were pregnant in the prior 9 months (e.g. time since prior survey). Women also took a urine pregnancy test at each time point. We categorized women has having a pregnancy during follow-up if a woman reported a current pregnancy, reported a pregnancy in the prior 9 months, or had a positive pregnancy test, at |
| Unintended pregnancy | Women were asked for each pregnancy ‘when you got pregnant, did you want to get pregnant at that time?’. Women who answered ‘no’ to this item (indicating either mistimed or unwanted pregnancy) for any pregnancy at either 9-month or 18-month survey were considered to have an unintended pregnancy during follow-up. |
References:
1. Hubacher D, Trussell J. A definition of modern contraceptive methods. Contraception 2015; 92(5): 420–1.
2. IIPS & ICF. National Family Health Survey (NFHS-4) 2015–16. Mumbai, India, 2017.
Figure 1CHARM2 recruitment and retention CONSORT flow diagram.
Characteristics of CHARM2 participants at baseline, by treatment status (n = 1201).
| Overall | Control | Intervention | ||
|---|---|---|---|---|
| Wife age, mean (SD) | 23.9 (3.0) | 23.9 (3.0) | 23.9 (2.9) | 0.96 |
| Husband age, mean (SD) | 29.4 (3.8) | 29.4 (3.7) | 29.4 (3.9) | 0.80 |
| Wife age at marriage, mean (SD) | 19.4 (2.3) | 19.4 (2.4) | 19.5 (2.3) | 0.55 |
| Child marriage (wife married <18) | 0.50 | |||
| No | 987 (82.2%) | 489 (81.4%) | 498 (83.0%) | |
| Yes | 214 (17.8%) | 112 (18.6%) | 102 (17.0%) | |
| Couple age difference H-W, mean (SD) | 5.6 (3.2) | 5.5 (3.1) | 5.6 (3.3) | 0.80 |
| Wife parity | 0.31 | |||
| 0 | 197 (16.4%) | 92 (15.3%) | 105 (17.5%) | |
| 1 | 644 (53.6%) | 324 (53.9%) | 320 (53.3%) | |
| 2 | 315 (26.2%) | 157 (26.1%) | 158 (26.3%) | |
| 3+ | 45 (3.7%) | 28 (4.7%) | 17 (2.8%) | |
| Wife highest education completed | 0.24 | |||
| Primary or No education (0–8) | 169 (14.1%) | 93 (15.5%) | 76 (12.7%) | |
| Secondary (9–10) | 345 (28.7%) | 163 (27.1%) | 182 (30.3%) | |
| Higher secondary (11–12) | 321 (26.7%) | 169 (28.1%) | 152 (25.3%) | |
| Post secondary(13+) | 366 (30.5%) | 176 (29.3%) | 190 (31.7%) | |
| Husband highest education completed | 0.94 | |||
| Primary or No education (0–8) | 174 (14.5%) | 86 (14.3%) | 88 (14.7%) | |
| Secondary (9–10) | 368 (30.6%) | 188 (31.3%) | 180 (30.0%) | |
| Higher secondary (11–12) | 305 (25.4%) | 154 (25.6%) | 151 (25.2%) | |
| Post secondary(13+) | 354 (29.5%) | 173 (28.8%) | 181 (30.2%) | |
| Wife worked in past year | 0.27 | |||
| No | 556 (46.3%) | 288 (47.9%) | 268 (44.7%) | |
| Yes | 645 (53.7%) | 313 (52.1%) | 332 (55.3%) | |
| Husband worked in past year | – | |||
| No | 0 (0%) | 0 (0%) | 0 (0%) | |
| Yes | 1201 (100%) | 601 (100%) | 600 (100%) | |
| Religion | <0.001 | |||
| Hindu | 1110 (92.4%) | 529 (88.0%) | 581 (96.8%) | |
| Muslim/Buddhist/Jain/Christian/Other | 91 (7.6%) | 72 (12.0%) | 19 (3.2%) | |
| SCST designation | 0.29 | |||
| None/other | 818 (68.1%) | 418 (69.6%) | 400 (66.7%) | |
| SC/ST/OBC | 383 (31.9%) | 183 (30.4%) | 200 (33.3%) | |
| Husband-reported avg mo income Rs, mean (SD) | 25,182 (51,131) | 27,046 (64,613) | 23,315 (32,384) | 0.21 |
| Household has BPL card | 0.84 | |||
| No | 902 (75.2%) | 453 (75.5%) | 449 (75.0%) | |
| Yes | 297 (24.8%) | 147 (24.5%) | 150 (25.0%) | |
| Has living son | 0.52 | |||
| No | 645 (53.7%) | 317 (52.7%) | 328 (54.7%) | |
| Yes | 556 (46.3%) | 284 (47.3%) | 272 (45.3%) | |
| Mother-in-law lives in same household | 0.097 | |||
| No | 240 (20.0%) | 132 (22.0%) | 108 (18.0%) | |
| Yes | 961 (80.0%) | 469 (78.0%) | 492 (82.0%) |
Fisher's exact test (categorical) or t-test (continuous), control versus intervention.
Difference-in-differences logistic regression time-treatment interaction effects, assessing CHARM2 impact on modern contraceptive use, contraceptive communication, joint contraceptive decision-making, and contraceptive agency.
| Outcome | Interaction | Simple | Adjusted | |||||
|---|---|---|---|---|---|---|---|---|
| ROR | 95% CI | p-value | AROR | 95% CI | p-value | ICC | ||
| Current modern contraceptive use | Intervention # 9mo follow-up | 1.59 | [1.07,2.37] | 0.022 | 1.54 | [1.03,2.29] | 0.035 | 0.0081 |
| Intervention # 18mo follow-up | 0.79 | [0.44,1.41] | 0.42 | 0.78 | [0.44,1.39] | 0.40 | ||
| Contraceptive communication | Intervention # 9mo follow-up | 1.96 | [1.06,3.60] | 0.057 | 1.93 | [1.04,3.58] | 0.037 | 0.0111 |
| Intervention # 18mo follow-up | 2.67 | [1.47,4.84] | 0.032 | 2.66 | [1.46,4.84] | 0.001 | ||
| Joint contraceptive decision-making | Intervention # 9mo follow-up | 1.48 | [0.90,2.42] | 0.12 | 1.45 | [0.89,2.36] | 0.14 | 0.0057 |
| Intervention # 18mo follow-up | 1.46 | [0.78,2.75] | 0.23 | 1.46 | [0.77,2.78] | 0.25 | ||
| Contraceptive self-efficacy: How sure are you that you could tell your husband that you wanted to use family planning? | Intervention # 9mo follow-up | 5.13 | [1.17,22.42] | 0.030 | 5.12 | [1.17,22.44] | 0.030 | <0.0001 |
| Intervention # 18mo follow-up | 8.25 | [1.37,49.59] | 0.021 | 8.08 | [1.35,48.19] | 0.022 | ||
| Contraceptive self-efficacy: How sure are you that you could use family planning? | Intervention # 9mo follow-up | 2.64 | [1.17,5.96] | 0.020 | 2.56 | [1.15,5.70] | 0.021 | 0.0435 |
| Intervention # 18mo follow-up | 1.46 | [0.54,3.97] | 0.46 | 1.41 | [0.53,3.75] | 0.49 | ||
| Contraceptive self-efficacy: How sure are you that you could use family planning, even if your husband did not want to? | Intervention # 9mo follow-up | 1.20 | [0.76,1.91] | 0.43 | 1.20 | [0.76,1.89] | 0.44 | 0.0156 |
| Intervention # 18mo follow-up | 1.23 | [0.72,2.12] | 0.45 | 1.22 | [0.71,2.11] | 0.46 | ||
| Equal right to choose contraceptive method | Intervention # 9mo follow-up | 2.55 | [1.04,6.25] | 0.041 | 2.52 | [1.03,6.16] | 0.044 | 0.0046 |
| Intervention # 18mo follow-up | 1.74 | [0.72,4.17] | 0.22 | 1.75 | [0.73,4.21] | 0.21 | ||
Limited to non-pregnant women.
Simple models include time (baseline, 9-month follow-up, 18-month follow-up), treatment status, and time-treatment interaction, with individual nested within subcenter random intercepts to account for repeated measures over time and subcenter clustering.
Adjusted models include same specifications as simple models, as well as baseline indicators of religion, wife living in the same household as her mother-in-law, wife and husband age, wife age at marriage, wife parity, having a living son, scheduled tribe/scheduled caste designation, and BPL card ownership.
Intracluster correlation coefficient, adjusted model.
Regression model treatment effects assessing effects of CHARM2 intervention on pregnancy and pregnancy intention in the follow-up period.
| Outcome | Intervention vs control, unadjusted | Intervention vs control, adjusted | ||||
|---|---|---|---|---|---|---|
| OR | 95% CI | p-value | AOR | 95% CI | p-value | |
| Any pregnancy in the follow-up time period | 0.86 | [0.70,1.07] | 0.18 | 0.83 | [0.65,1.06] | 0.13 |
| Unintended pregnancy in the follow-up time period | 0.89 | [0.58,1.38] | 0.62 | 0.93 | [0.56,1.55] | 0.79 |
| Three-level pregnancy outcome | ||||||
| No pregnancy | ||||||
| Intended pregnancy(ies) only | 0.90 | [0.73,1.11] | 0.34 | 0.81 | [0.52,1.26] | 0.23 |
| Unintended pregnancy(ies) | 0.85 | [0.64,1.11] | 0.35 | 0.83 | [0.54,1.27] | 0.39 |
Mixed-effects logistic regression, accounting for clustering using subcenter random intercepts.
Limited to women with a pregnancy in in the follow-up time period.
Multinomial logistic regression, accounting for clustering using clustering variance estimation specifications on subcenter.
Adjusted models include baseline indicators of religion, wife living in the same household as her mother-in-law, wife and husband age, wife age at marriage, wife parity, having a living son, scheduled tribe/scheduled caste designation, and BPL card ownership.
Participant satisfaction - summary items. Intervention participants only.
| Wife | Husband | |||||
|---|---|---|---|---|---|---|
| N | % | % nonmissing | N | % | % nonmissing | |
| Do you think this program has helped you in your daily life? | ||||||
| Very much | 396 | 73.7 | 75.6 | 387 | 69.9 | 74.0 |
| Somewhat | 123 | 22.9 | 23.5 | 117 | 21.1 | 22.4 |
| Not at all | 5 | 0.9 | 1.0 | 19 | 3.4 | 3.6 |
| Declined | 13 | 2.4 | – | 31 | 5.6 | – |
| Do you think this program should be continued beyond the study time period? | ||||||
| Very much | 405 | 75.4 | 76.6 | 394 | 71.1 | 75.1 |
| Somewhat | 120 | 22.4 | 22.7 | 118 | 21.3 | 22.5 |
| Not at all | 4 | 0.7 | 0.8 | 13 | 2.4 | 2.5 |
| Declined | 8 | 1.5 | – | 29 | 5.2 | – |
| How responsive was the health provider to you about your health and marital concerns? | ||||||
| Very much | 401 | 74.7 | 78.5 | 396 | 71.5 | 79.5 |
| Somewhat | 110 | 20.5 | 21.5 | 100 | 18.1 | 20.1 |
| Not at all | 0 | 0 | 0 | 2 | 0.4 | 0.4 |
| Declined | 26 | 4.8 | – | 56 | 10.1 | – |