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Assessing the capacity and findings of routine programmatic data in Kenya to guide decision-making around contraceptives and antiretroviral therapy
BMC Medicine ( IF 9.3 ) Pub Date : 2021-08-13 , DOI: 10.1186/s12916-021-02066-6
Beth A Tippett Barr 1
Affiliation  

The World Health Organization’s comprehensive strategic approach to prevention of mother-to-child transmission of HIV (PMTCT) covers the “4-prongs” of PMTCT programming: primary prevention of HIV; prevention of unintended pregnancies; prevention of vertical transmission from mother to infant; and provision of treatment, care, and support to mothers and infants [1, 2].

In resource-constrained settings, ensuring universal access to contraceptive options can be logistically challenging, and this is further complicated by the potentially reduced effectiveness of some long-term contraceptives in the presence of specific antiretrovirals. Clinician and patient contraceptive and antiretroviral therapy (ART) decisions are made within the larger context of standardized national guidelines and standardized essential medicines procurement at the national level, which, while simplifying procurement and improving cost-efficiency for the national health system [3], may not allow for a wide array of options available to individual patients.

This provision of ART and contraceptives becomes particularly problematic in situations where negative drug interactions are reported after the national introduction of new guidelines and commodities. Patel and colleagues [4] refer to the recent global “scare” about a potential association between dolutegravir use in pregnancy and neural tube defects [5] and how the subsequent rapid transition of some national programs to an efavirenz (EFV)-based ART regimen had the undesired knock-on effect of potentially reducing effectiveness of long-term contraceptive use in women who were on EFV, which they had reported in an earlier paper [6].

In this paper, Patel and colleagues comment on Kenya’s “robust national electronic medical record (EMR) system” [4] and follow-up their previous paper [6] by conducting a study with the dual intent of (1) conducting “a three-phase validation study” on the ability of strong national EMRs to provide accurate and reliable data to guide decision-making and (2) to better estimate the associations between long-term contraceptive methods, EFV-containing ART regimens, and incident pregnancy [4].

The three-phase validation included EMR review of 4 years of records from over 85,000 women living with HIV (WLHIV) (> 170,000 person-years of observation), 5000 random chart abstractions, and 1000 phone interviews with women who did and did not become pregnant using EFV and long-term contraceptive methods. Using these methods, Patel and colleagues planned to pool program data to determine if there is reduced contraceptive effectiveness in a real-world setting, while simultaneously confirming that the national program data used for analysis is reliable enough to guide future decision-making around contraceptive choices and ART regimens.

Data validation

On the data-validation objective of the study, Patel demonstrated that all three sampling methods provided overlapping confidence intervals, or non-significant variation, on the associations between long-term contraceptive methods including implants and depomedroxyprogesterone acetate (DMPA) and various ART regimens, thus validating the accuracy of routine program data from the EMR.

Contraceptive use and ART

Approximately half of the women used contraceptives, one quarter of the women were on an EFV-based regimen, and there were nearly 13,000 incident pregnancies. The key finding was that women on EFV-containing regimens who were using implants to prevent pregnancy had increased weighted adjusted incident rate ratios (aIRRs) across all sampling methods: 1.9 (95% CI 1.6–2.4) in the EMR, 2.3 (95% CI 1.5–3.5) in chart review, and 3.2 (95% CI 1.8–5.7) in phone interviews. There was little to no evidence to support an increased pregnancy aIRR between DMPA and any of the ART regimens or between implants and non-EFV containing regimens.

Patel and colleagues’ recommendations

Patel concluded the paper with three key recommendations: (1) countries can be more careful not to overreact to early reports of negative findings around drug-drug or drug-device interactions, (2) ensure individual women have information they need to make wise decisions, and (3) WLHIV are included in policy decision-making.

Data validation

This paper strengthens the literature by providing a resource for countries who may be seeking to understand the strengths and weaknesses of their own EMRs to guide decision-making in the face of changing global guidelines. This is a positive reflection on the significant donor investments and political will supporting development of health information systems in resource-constrained settings and highlights the strengths of programming at a centralized national level.

Contraceptive use and ART

While the concurrent use of EFV-based ART and implants may not be relevant to the greatest proportion of WLHIV in their reproductive years, it remains a relevant issue to a large absolute number of women globally. In considering national program guidelines, it is important to consider equally the Family Planning (FP) and ART needs of women and ensure access to options, particularly in FP.

The authors focus primarily on the individual patient level needs in the face of national decision-making, but what they do not address in their conclusions is the very real challenge associated with national and sub-national supply chain management in resource-constrained settings. Standardized health systems and utilization of essential medicine lists mean not only that contraceptives and antiretrovirals are ordered by the millions but that there is a significant lead time between procurement and distribution of commodities in-country, usually in excess of 6 months, even when supply chain channels are well-established [7]. As a result, any decision to change ART regimens or relative availability and choice of contraceptives will take many months to be realized at the patient level. All stages of changing guidelines and supply chain management are further complicated by the reality that even when services are integrated at facility level, management of family planning and HIV programming at national and sub-national levels are infrequently managed in the same departments of the Ministry of Health. Any changes in one program that affect the other may require coordination across technical working groups and agreement across many more stakeholders, including donors.

These national level programming and supply chain challenges support Patel and colleagues’ recommendations that more caution could be taken before making changes to national guidelines. The ability of the EMR in Kenya to provide accurate estimates on the negative interactions between Efavirenz and hormonal implants provides clear direction for both identifying and reporting safety signals in the coming years.

Not applicable

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    World Health Organization, Department of HIV/AIDS prevention of mother-to-child transmission (PMTCT) Briefing Note October 1st, 2007. Available at Microsoft Word - PMTCT Generic Briefing.doc (who.int)

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    World Health Organization, HIV/AIDS Programme. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: Towards universal access. 2006. Available at ARVPregnantWomen.indd (who.int)

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    Kenya Ministry of Health. Kenya Essential Medicines List (KEML). 2019. Available at KEML 2019_full ver, 13th Dec 2019.indd (health.go.ke)

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    Patel RC, Amorim G, Jakait B, Shepherd BE, Mocello AR, Musick B, et al. Pregnancies among women living with HIV using contraceptives and antiretroviral therapy in western Kenya: a retrospective, cohort study. BMC Medicine. 2021; publication pending.

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    Zash R, Makhema J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med. 2018;379(10):979–81. https://doi.org/10.1056/NEJMc1807653.

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    Patel RC, Onono M, Gandhi M, Blat C, Hagey J, Shade SB, et al. Pregnancy rates in HIV positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study. Lancet HIV. 2015;2(11):e474–82. https://doi.org/10.1016/S2352-3018(15)00184-8.

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Affiliations

  1. U.S. Centers for Disease Control and Prevention, Kisumu, Kenya

    Beth A. Tippett Barr

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BTB wrote the comment. The author read and approved the final manuscript.

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Correspondence to Beth A. Tippett Barr.

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The author declares that there are no competing interests.

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Tippett Barr, B.A. Assessing the capacity and findings of routine programmatic data in Kenya to guide decision-making around contraceptives and antiretroviral therapy. BMC Med 19, 192 (2021). https://doi.org/10.1186/s12916-021-02066-6

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Keywords

  • HIV
  • Prevention of mother-to-child transmission (PMTCT)
  • Contraceptives
  • Efficacy
  • Integrated services
  • Electronic medical records (EMR)
  • Program data
  • Surveillance
  • Safety signals
  • Drug interactions


中文翻译:

评估肯尼亚常规规划数据的能力和结果,以指导围绕避孕药具和抗逆转录病毒治疗的决策

世界卫生组织预防 HIV 母婴传播 (PMTCT) 的综合战略方法涵盖了 PMTCT 规划的“四个方面”:HIV 的初级预防;预防意外怀孕;预防母婴垂直传播;以及为母亲和婴儿提供治疗、护理和支持 [1, 2]。

在资源有限的环境中,确保普遍获得避孕药具在后勤方面可能具有挑战性,并且在存在特定抗逆转录病毒药物的情况下,某些长期避孕药具的有效性可能会降低,从而使情况变得更加复杂。临床医生和患者的避孕和抗逆转录病毒治疗 (ART) 决定是在标准化的国家指南和标准化的国家级基本药物采购的更大背景下做出的,同时简化了国家卫生系统的采购并提高了成本效益 [3],可能不允许为个别患者提供多种选择。

在国家引入新的指导方针和商品报告出现药物不良相互作用的情况下,ART 和避孕药具的提供尤其成问题。Patel 及其同事 [4] 提到最近全球“恐慌”,即妊娠期使用多替拉韦与神经管缺陷 [5] 之间的潜在关联,以及随后一些国家计划如何快速过渡到基于依非韦伦 (EFV) 的 ART 方案具有不希望的连锁效应,可能会降低使用 EFV 的女性长期使用避孕药的有效性,他们在较早的一篇论文中报道了这一点 [6]。

在这篇论文中,Patel 及其同事对肯尼亚的“强大的国家电子病历 (EMR) 系统”[4] 进行了评论,并通过进行一项具有双重意图的研究来跟进他们之前的论文 [6]:(1) 进行“三阶段验证研究”关于强大的国家 EMR 提供准确可靠的数据以指导决策和 (2) 更好地估计长期避孕方法、包含 EFV 的 ART 方案和意外怀孕之间的关联的能力 [4] ]。

三阶段验证包括 EMR 审查来自超过 85,000 名艾滋病毒感染者 (WLHIV) 的 4 年记录(> 170,000 人年的观察)、5000 次随机图表抽象,以及 1000怀孕使用 EFV 和长期避孕方法。使用这些方法,Patel 及其同事计划汇集项目数据,以确定在现实环境中避孕效果是否降低,同时确认用于分析的国家项目数据足够可靠,可以指导未来围绕避孕选择的决策和 ART 方案。

数据验证

在研究的数据验证目标中,Patel 证明,所有三种采样方法都提供了重叠的置信区间,或非显着变化,关于长期避孕方法(包括植入物和醋酸去甲羟孕酮(DMPA))与各种 ART 方案之间的关联,从而验证来自 EMR 的例行程序数据的准确性。

避孕药具的使用和 ART

大约一半的女性使用避孕药具,四分之一的女性使用基于 EFV 的方案,并且有近 13,000 次意外怀孕。关键发现是,在所有采样方法中,使用含 EFV 方案的女性使用植入物预防怀孕的加权调整事件率比 (aIRR) 有所增加:EMR 中为 1.9 (95% CI 1.6–2.4),2.3 (95% CI 1.5-3.5)在图表审查中,3.2(95% CI 1.8-5.7)在电话采访中。几乎没有证据支持 DMPA 和任何 ART 方案之间或植入物和不含 EFV 的方案之间增加妊娠 aIRR。

Patel 和同事的建议

帕特尔总结了三项关键建议:(1) 各国可以更加小心,不要对早期关于药物-药物或药物-器械相互作用的负面结果的报告反应过度,(2) 确保个别女性获得做出明智决定所需的信息,以及 (3) WLHIV 被纳入政策决策。

数据验证

本文通过为可能寻求了解其自身 EMR 的优势和劣势的国家提供资源来加强文献,以指导面对不断变化的全球指南的决策。这是对支持在资源受限环境中发展卫生信息系统的重要捐助者投资和政治意愿的积极反映,并突出了中央国家级规划的优势。

避孕药具的使用和 ART

虽然同时使用基于 EFV 的 ART 和植入物可能与育龄期 WLHIV 的最大比例无关,但对于全球大量绝对数量的女性来说,这仍然是一个相关问题。在考虑国家计划指南时,重要的是要平等考虑妇女的计划生育 (FP) 和 ART 需求,并确保获得选择权,尤其是在 FP 中。

作者在面对国家决策时主要关注个体患者层面的需求,但他们在结论中没有解决的是与资源受限环境中的国家和次国家供应链管理相关的非常现实的挑战。标准化的卫生系统和基本药物清单的使用不仅意味着数以百万计的避孕药具和抗逆转录病毒药物的订购,而且在国内采购和分配商品之间有很长的提前期,通常超过 6 个月,即使供应链渠道完善[7]。因此,任何改变 ART 方案或相对可用性和避孕药具选择的决定都需要数月时间才能在患者层面上实现。不断变化的指导方针和供应链管理的所有阶段都进一步复杂化,因为即使服务在设施层面进行整合,国家和地方层面的计划生育和艾滋病规划管理也很少在卫生部的同一部门进行管理。健康。一项计划中影响另一项计划的任何变化可能需要技术工作组之间的协调以及更多利益相关者(包括捐助者)的同意。

这些国家级规划和供应链挑战支持 Patel 及其同事的建议,即在更改国家指南之前可以更加谨慎。肯尼亚 EMR 能够准确估计依法韦仑和激素植入物之间的负面相互作用,为未来几年识别和报告安全信号提供了明确的方向。

不适用

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    世界卫生组织,艾滋病毒/艾滋病预防母婴传播部 (PMTCT) 简报,2007 年 10 月 1 日。可在 Microsoft Word 中获得 - PMTCT Generic Briefing.doc (who.int)

  2. 2.

    世界卫生组织,艾滋病毒/艾滋病计划。用于治疗孕妇和预防婴儿 HIV 感染的抗逆转录病毒药物:走向普遍可及。2006. 可在 ARVPregnantWomen.indd (who.int) 获得

  3. 3.

    肯尼亚卫生部。肯尼亚基本药物清单 (KEML)。2019. 可在 KEML 2019_full ver, 13th Dec 2019.indd (health.go.ke) 获得

  4. 4.

    Patel RC、Amorim G、Jakait B、Shepherd BE、Mocello AR、Musick B 等。在肯尼亚西部使用避孕药具和抗逆转录病毒疗法的艾滋病毒感染者怀孕:一项回顾性队列研究。BMC医学。2021;出版待定。

  5. 5.

    Zash R、Makhema J、Shapiro RL。从受孕开始使用 dolutegravir 治疗的神经管缺陷。N Engl J Med。2018;379(10):979-81。https://doi.org/10.1056/NEJMc1807653。

    文章 PubMed PubMed Central Google Scholar

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    Patel RC、Onono M、Gandhi M、Blat C、Hagey J、Shade SB 等。在肯尼亚使用避孕药和基于依法韦仑或基于奈韦拉平的抗逆转录病毒疗法的 HIV 阳性妇女的妊娠率:一项回顾性队列研究。柳叶刀艾滋病毒。2015;2(11):e474-82。https://doi.org/10.1016/S2352-3018(15)00184-8。

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  7. 7.

    个人谈话

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  1. 美国疾病控制与预防中心,肯尼亚基苏木

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Tippett Barr, BA 评估肯尼亚常规项目数据的能力和结果,以指导围绕避孕药具和抗逆转录病毒治疗的决策。BMC Med 19, 192 (2021)。https://doi.org/10.1186/s12916-021-02066-6

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关键词

  • 艾滋病病毒
  • 预防母婴传播 (PMTCT)
  • 避孕药
  • 功效
  • 综合服务
  • 电子病历 (EMR)
  • 节目资料
  • 监视
  • 安全信号
  • 药物相互作用
更新日期:2021-08-13
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