Anita Raj , Nicole Johns , Florin Vaida , Mohan Ghule , Namratha Rao , Jay G. Silverman
{"title":"CHARM2是一项有效的计划生育干预措施,对出生人数和性别进行了四年的随访:来自印度农村地区的一项随机对照试验的结果","authors":"Anita Raj , Nicole Johns , Florin Vaida , Mohan Ghule , Namratha Rao , Jay G. Silverman","doi":"10.1016/j.dialog.2025.100218","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>Our non-blinded two-armed cluster RCT randomized young married couples (<em>N</em> = 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.</div></div><div><h3>Results</h3><div>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, <em>p</em> = 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], <em>p</em> = 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 %, <em>p</em> = 0.03).</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Funding</h3><div>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. [<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT03514914</span><svg><path></path></svg></span>.]</div></div>","PeriodicalId":72803,"journal":{"name":"Dialogues in health","volume":"6 ","pages":"Article 100218"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Four-year follow-up of CHARM2, an effective family planning intervention, on number and sex of births: Findings from an RCT in rural India\",\"authors\":\"Anita Raj , Nicole Johns , Florin Vaida , Mohan Ghule , Namratha Rao , Jay G. Silverman\",\"doi\":\"10.1016/j.dialog.2025.100218\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>Our non-blinded two-armed cluster RCT randomized young married couples (<em>N</em> = 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.</div></div><div><h3>Results</h3><div>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, <em>p</em> = 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], <em>p</em> = 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 %, <em>p</em> = 0.03).</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Funding</h3><div>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. [<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT03514914</span><svg><path></path></svg></span>.]</div></div>\",\"PeriodicalId\":72803,\"journal\":{\"name\":\"Dialogues in health\",\"volume\":\"6 \",\"pages\":\"Article 100218\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dialogues in health\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2772653325000152\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dialogues in health","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772653325000152","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
在印度,由于重男轻女,有效的计划生育干预措施可能会对女孩的出生产生无意的影响。我们对CHARM2计划生育研究进行了36个月和48个月的随访,以确定长期干预对出生和儿童性别的影响。方法采用非盲双臂随机对照试验,将20个地理分组(每组60-61对)的年轻已婚夫妇(N = 1201对)随机分为CHARM2干预组和对照组(转到当地护理)。CHARM2提供由训练有素的当地医疗提供者提供的五期性别同步计划生育和性别平等咨询。在2018年9月至2019年6月期间收集基线数据,然后在9个月、18个月、36个月和48个月进行随访,直至2023年9月。在随访期间,我们保留了88% - 91%的女性保留率,不同治疗组的保留率没有差异。我们使用调整后的混合效应logistic回归模型,检查每次随访和48个月随访期间出生的性别组成,以评估治疗组所有男孩和女孩出生的差异。在调整后的模型中,我们调整了治疗条件、集群和相关人口统计数据。结果:我们没有看到治疗对总出生数或男孩出生数的影响,但在9个月的随访和48个月的随访期间,发现女孩出生的可能性较低。我们发现,在9个月的随访中,与对照组相比,女孩出生的可能性更小(分别为7.1%和10.3%,p = 0.06),在基线和9个月随访期间出生的男女性别比,干预组也显著高于对照组(1.50 [95% CI 1.00-2.26]比0.83 [95% CI 0.56-1.21], p = 0.04)。在48个月的随访中,我们进行了敏感性分析,以确定治疗对男孩出生和女孩出生的影响,再次发现对男孩出生没有影响,但干预组出生女孩的可能性显着降低(22%对29%,p = 0.03)。CHARM2计划生育干预措施在印度农村对避孕药具的使用和妇女生殖机构产生了显著影响,但随着时间的推移,该措施导致女孩出生的可能性降低,这表明,如果不发生更广泛的社会变革,消除重男轻女和提高女孩的价值,计划生育计划可能会导致性别比例失衡。美国国立卫生研究院,拨款R01HD084453比尔和梅林达·盖茨基金会。INV002967。资助者在研究的设计和实施、数据的收集、管理、分析和解释中没有任何作用;或手稿的准备、审查或批准;或决定投稿发表。[ClinicalTrials.gov标识符:NCT03514914.]
Four-year follow-up of CHARM2, an effective family planning intervention, on number and sex of births: Findings from an RCT in rural India
Background
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.
Methods
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.
Results
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).
Conclusion
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.
Funding
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.]