{"title":"印度早期婴儿诊断（EID）项目诊断的18个月以下艾滋病毒阳性婴儿的临床结果：一项混合方法研究","authors":"Suchit Kamble , Nilesh Gawde , Shilpa Bembalkar , Noopur Goel , Mohan Thorwat , Kalyani Nikhare , Sushmita Kamble , Radhika Brahme , Swapna Pawar , Harsh Kubavat , Bhawanisingh Kushwaha , Vinita Verma , Chinmoyee Das , Raman Gangakhedkar","doi":"10.1016/j.lansea.2025.100540","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Early Anti-Retroviral Therapy (ART) initiation among infants with perinatally acquired HIV is known to impact clinical outcomes and survival. Early Infant Diagnosis (EID) was initiated in programme settings in India in 2010. Its impact on the clinical outcomes of infants covered under the programme and associated determinants have not been reported.</div></div><div><h3>Methods</h3><div>This was a mixed-methods study. Quantitative clinical data of 310 children on ART with HIV diagnosis before 18 months of age was collected from the treatment cards across 30 ART centres from 11 states of India using a retrospective cohort design. A total of 67 In-depth interviews with healthcare providers and managers helped to understand the underlying causes.</div></div><div><h3>Findings</h3><div>Out of 310 infants, 200 (64.5%) were on ART, and 36 (11.6%) were lost to follow-up, and 25 (8.1%) had died. The median age at HIV diagnosis was 231.5 (130, 405) days, and the median age at ART initiation was 309 (198, 456) days. Three-year survival was 91%. Baseline CD4 count less than 1500 cells/mm<sup>3</sup> had a higher hazard for mortality (hazard ratio 11.39 (CI: 1.45, 89.45), p = 0.021) as well as for either mortality or development of opportunistic infections (hazard ratio 4.87 (CI: 1.56, 15.15), p = 0.006). WHO clinical stages III and IV had hazard ratios of 2.42 ((CI: 1.43, 4.09), p = 0.001) for mortality and 1.92 ((CI: 1.28, 2.88), p = 0.001) for death or development of opportunistic infections. Demand-side issues such as stigma and discrimination at family, community, and societal levels, desperation about the survival of the child, supply-side factors such as remote access to paediatric ART centres, and lack of paediatric ART medicine formulations were associated with ART treatment.</div></div><div><h3>Interpretation</h3><div>Overall survival was good for those who continued on treatment, but mortality was high for those with poor immunological and clinical parameters. Retention in care needs to be ensured for better clinical outcomes.</div></div><div><h3>Funding</h3><div>The study was commissioned by the National AIDS Control Programme (T.11020/98/2014-NACO (R&D)) and funded through The <span>Global Fund Against AIDS, TB and Malaria (GFATM)</span> grant.</div></div>","PeriodicalId":75136,"journal":{"name":"The Lancet regional health. 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引用次数: 0
摘要
背景围产期获得性艾滋病毒婴儿开始抗逆转录病毒治疗（ART）会影响临床结果和生存。2010年，印度在规划环境中启动了婴儿早期诊断（EID）。它对该计划所涵盖的婴儿临床结果的影响和相关决定因素尚未报道。方法采用混合方法进行研究。采用回顾性队列设计，从印度11个邦30个抗逆转录病毒治疗中心的治疗卡中收集了310名接受抗逆转录病毒治疗的18个月前诊断为艾滋病毒的儿童的定量临床数据。与医疗保健提供者和管理人员共进行了67次深入访谈，有助于了解潜在原因。结果：在310名婴儿中，200名（64.5%）接受了ART治疗，36名（11.6%）失去随访，25名（8.1%）死亡。HIV诊断的中位年龄为231.5天（130,405），ART治疗的中位年龄为309天（198,456）。3年生存率为91%。基线CD4计数低于1500个细胞/mm3具有较高的死亡率（风险比11.39 (CI: 1.45, 89.45), p = 0.021）以及死亡率或机会性感染的发生（风险比4.87 (CI: 1.56, 15.15), p = 0.006）。WHO临床III期和IV期死亡率的风险比为2.42 （CI: 1.43, 4.09)，发生机会性感染的风险比为1.92 (CI: 1.28, 2.88), p = 0.001）。需求方面的问题，如家庭、社区和社会层面的耻辱和歧视，对儿童生存的绝望，供给方面的因素，如远程进入儿科抗逆转录病毒治疗中心，以及缺乏儿科抗逆转录病毒治疗药物配方，都与抗逆转录病毒治疗有关。继续接受治疗的患者总体生存率较高，但免疫和临床参数较差的患者死亡率较高。为了获得更好的临床结果，需要确保患者留在护理中。该研究由国家艾滋病控制规划（T.11020/98/2014-NACO (R&；D)）委托，由全球防治艾滋病、结核病和疟疾基金（GFATM）资助。
Clinical outcomes among HIV positive babies below 18 months of age, diagnosed under the Early Infant Diagnosis (EID) programme, India: a mixed-methods study
Background
Early Anti-Retroviral Therapy (ART) initiation among infants with perinatally acquired HIV is known to impact clinical outcomes and survival. Early Infant Diagnosis (EID) was initiated in programme settings in India in 2010. Its impact on the clinical outcomes of infants covered under the programme and associated determinants have not been reported.
Methods
This was a mixed-methods study. Quantitative clinical data of 310 children on ART with HIV diagnosis before 18 months of age was collected from the treatment cards across 30 ART centres from 11 states of India using a retrospective cohort design. A total of 67 In-depth interviews with healthcare providers and managers helped to understand the underlying causes.
Findings
Out of 310 infants, 200 (64.5%) were on ART, and 36 (11.6%) were lost to follow-up, and 25 (8.1%) had died. The median age at HIV diagnosis was 231.5 (130, 405) days, and the median age at ART initiation was 309 (198, 456) days. Three-year survival was 91%. Baseline CD4 count less than 1500 cells/mm3 had a higher hazard for mortality (hazard ratio 11.39 (CI: 1.45, 89.45), p = 0.021) as well as for either mortality or development of opportunistic infections (hazard ratio 4.87 (CI: 1.56, 15.15), p = 0.006). WHO clinical stages III and IV had hazard ratios of 2.42 ((CI: 1.43, 4.09), p = 0.001) for mortality and 1.92 ((CI: 1.28, 2.88), p = 0.001) for death or development of opportunistic infections. Demand-side issues such as stigma and discrimination at family, community, and societal levels, desperation about the survival of the child, supply-side factors such as remote access to paediatric ART centres, and lack of paediatric ART medicine formulations were associated with ART treatment.
Interpretation
Overall survival was good for those who continued on treatment, but mortality was high for those with poor immunological and clinical parameters. Retention in care needs to be ensured for better clinical outcomes.
Funding
The study was commissioned by the National AIDS Control Programme (T.11020/98/2014-NACO (R&D)) and funded through The Global Fund Against AIDS, TB and Malaria (GFATM) grant.
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