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正在招募不适用编号 NCT06639932

We-INtervention Among Chinese HIV-serodiscordant Male Couples

报名条件（概要）

  • 年龄：18 Years – 不限
  • 性别：男性
  • 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

China

药品与企业信息

We-INtervention行为干预

The We-INtervention focuses on the relationship dynamics of HIV-serodiscordant male couples. In developing the intervention, we reviewed relevant theories and frameworks, such as the cognitive transactional model, the systemic transactional model, the dyadic illness management model, and the intersectional framework of stigma. The three weekly 60-minute sessions are Session 1: We-disease appraisal. Despite stigma related to their dual minority identities, couples develop a perception of HIV as a shared disease, enhancing illness control. Session 2: Couple communication. Couples undertake skill-building exercises on effective communication techniques to strengthen their relationship. Session 3: Dyadic coping. Couples learn to optimize preference and value assessments in HIV management. A few skill-building exercises help them mobilize and maintain mutual support and develop joint problem-solving skills.

Usual Care Group行为干预

The participants in the control condition will receive health information pamphlets. The HIV-seropositive partners will receive information on HIV-related knowledge (e.g., symptoms, comorbidity, stages, and opportunistic infection), treatment (e.g., ART and side effects), and management (e.g., nutrition and mental health). The HIV-seronegative partner will receive information on HIV transmission (e.g., risk factors), prevention (e.g., safe sex and PrEP), and testing.

研发企业

City University of Hong Kong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。

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）

HIV-serodiscordant male couples, in which one male partner is HIV-seropositive and the other is HIV-seronegative, experience multiple risks in HIV care and prevention. As stigma often hinders such couples' access to support and services, leveraging their relational resources is crucial for optimizing their outcomes. The proposed study will assess the efficacy of the three-session We-INtervention focusing on their relationship dynamics to enhance Chinese HIV-serodiscordant male couples' health and well-being. A total of 160 Chinese HIV-serodiscordant male couples (320 individuals: 160 HIV-seropositive and 160 HIV-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. In the intervention arm, the We-INtervention will be delivered to both partners of each couple separately. In the control arm, each couple will receive health information pamphlets.

适应症

HIV

主动联系研究团队

总联系人（申办方／研究总部）

中国／港澳台研究中心

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: We-INtervention Among Chinese HIV-serodiscordant Male Couples
ClinicalTrials.gov Identifier: NCT06639932
Sponsor: City University of Hong Kong
Investigational product: We-INtervention, Usual Care Group

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：We-INtervention Among Chinese HIV-serodiscordant Male Couples
试验编号：NCT06639932
申办方：City University of Hong Kong
研究药物：We-INtervention、Usual Care Group

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 nancy.yu@cityu.edu.hk

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