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正在招募IV 期编号 NCT06158126

UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

报名条件（概要）

  • 年龄：15 Years – 55 Years
  • 性别：女性
  • 健康志愿者：接受

完整入排标准请以官方页面为准。

开展国家/地区

Malawi

药品与企业信息

Initiating daily oral PrEP during pregnancy药物

其他名称：Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) or lamivudine (3TC) (FTC/TDF or TDF/3TC)

Group 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.

Already using daily oral PrEP at the time of pregnancy diagnosis药物

其他名称：Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) or lamivudine (3TC) (FTC/TDF or TDF/3TC)

Group 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.

Initiating injectable PrEP during pregnancy药物

其他名称：CAB-LA

Group 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.

Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis药物

其他名称：CAB-LA

Group 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.

研发企业

University of North Carolina, Chapel Hill研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)美国国立卫生研究院
  • United States President's Emergency Plan for AIDS Relief政府机构
  • Ministry of Health, MalawiOTHER_GOV

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is: \- Do composite adverse pregnancy events, maternal health outcomes, and/or infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA? Women who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period. In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.

适应症

Pre-exposure ProphylaxisHIV PreventionPregnancy Related

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人（申办方／研究总部）

问自己是否符合条件、如何预筛

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
ClinicalTrials.gov Identifier: NCT06158126
Sponsor: University of North Carolina, Chapel Hill
Investigational product: Initiating daily oral PrEP during pregnancy, Already using daily oral PrEP at the time of pregnancy diagnosis, Initiating injectable PrEP during pregnancy, Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
试验编号：NCT06158126
申办方：University of North Carolina, Chapel Hill
研究药物：Initiating daily oral PrEP during pregnancy、Already using daily oral PrEP at the time of pregnancy diagnosis、Initiating injectable PrEP during pregnancy、Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 cnakanga@unclilongwe.org

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面