Evaluating the impact of three progestin-based hormonal contraceptive methods on immunologic changes in the female genital tract and systemically (CHIME Study): a prospective cohort study protocol.

Evaluating the impact of three progestin-based hormonal contraceptive methods on immunologic changes in the female genital tract and systemically (CHIME Study): a prospective cohort study protocol.
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DOI:
10.1186/s12905-022-02053-w
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发表时间:
2022-11-18
期刊:
影响因子:
2.5
通讯作者:
Smith, Alicia K.
Smith, Alicia K.
中科院分区:
医学3区
文献类型:
--
作者:
Haddad, Lisa B.;Herring, Gina Bailey;Mehta, C. Christina;Staple, Tyree;Young, Marisa R.;Govindaraj, Sakthivel;Velu, Vijayakumar;Smith, Alicia K.

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性腺激素可以改变免疫功能,这可能会影响对传染病的易感性,包括人类免疫缺陷病毒(HIV)。关于激素避孕药(HC)在使用过程中如何影响免疫反应的知识有限。 CHIME 研究旨在评估长效孕激素类激素避孕药(醋酸甲羟孕酮长效制剂、依托孕烯埋植剂和左炔诺孕酮宫内节育器)对女性生殖道 (FGT) 和全身区室免疫变化的影响。 CHIME 是一项观察性队列研究,参与者在开始他们选择的 HC 方法之前参加 2 次访视,然后在 12 个月内参加 6 次访视,每次访视时进行生物采样(阴道拭子、宫颈阴道灌洗液、细胞刷和血液)进行免疫学、细菌学和病毒学分析。将通过多色流式细胞术评估免疫谱,以确定不同的 T 细胞亚群(特别是 CD4 T 细胞亚群)在避孕药使用过程中如何变化,以及与全身区室相比,它们在 FGT 中是否具有不同的谱。该研究的目的是 (1) 表征与三种长效纯孕激素 HC 相关的 FGT 和全身免疫特征的变化,以及 (2) 评估由 16 s rRNA 测序确定的阴道微环境,作为接触三种常用 HC 后生殖器和全身免疫特征变化的个体水平风险因素和调节因素。数据收集于 2019 年 3 月开始,计划于 2024 年 10 月完成。CHIME 研究旨在为旨在评估三种长效纯孕激素 HC 对先天和适应性免疫功能的比较影响的研究做出贡献,以了解免疫效应如何改变 STI 和 HIV 易感性。
Gonadal hormones can modify immune function, which may impact susceptibility to infectious diseases, including Human Immunodeficiency Virus (HIV). There is limited knowledge about how hormonal contraceptives (HC) influence the immune response during the course of use. The CHIME study aims to evaluate the effect of long-acting progestin-based hormonal contraceptives (depot medroxyprogesterone acetate, etonogestrel implant, and levonorgestrel intrauterine device) on immunologic changes in the female genital tract (FGT) and systemic compartment. CHIME is an observational cohort study where participants attend 2 visits prior to initiating the HC method of their choice, and then attend 6 visits over 12 months with biological sampling (vaginal swabs, cervicovaginal lavage, cytobrush and blood) for immunological, bacteriological, and virological analyses at each visit. Immune profiling will be evaluated by multi-color flow cytometry to determine how different T-cell subsets, in particular the CD4 T-cell subsets, change during the course of contraceptive use and whether they have different profiles in the FGT compared to the systemic compartment. The study aims are (1) to characterize the alterations in FGT and systemic immune profiles associated with three long-acting progestin-only HC and (2) to evaluate the vaginal microenvironment, determined by 16 s rRNA sequencing, as an individual-level risk factor and moderator of genital and systemic immune profile changes following exposure to three commonly used HC. Data collection started in March 2019 and is scheduled to be completed in October 2024. The CHIME study aims to contribute to the body of research designed to evaluate the comparative impact of three long-acting progestin-only HC on innate and adaptive immune functions to understand how immunologic effects alter STI and HIV susceptibility.
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