ChiCTR2600118365 版本V1.0 版本创建时间2026/02/04 16:18:58 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600118365 

最近更新日期：

Date of Last Refreshed on：

 2026-02-04 16:18:48 

注册时间：

Date of Registration：

 2026-02-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于健康行为改变整合理论的艾滋病感染者自我管理生态圈网络系统构建与初步应用

Public title：

Construction and preliminary application of a self-management ecosystem network system for people living with HIV/AIDS based on the integrated theory of health behavior change

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于健康行为改变整合理论的艾滋病感染者自我管理生态圈网络系统构建与初步应用

Scientific title：

Construction and preliminary application of a self-management ecosystem network system for people living with HIV/AIDS based on the integrated theory of health behavior change

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

朱志红 

研究负责人：

朱志红 

Applicant：

Zhihong Zhu 

Study leader：

Zhihong Zhu 

申请注册联系人电话：

Applicant telephone：

 +86 13750760025

研究负责人电话：

Study leader's
telephone：

+86 573 8251 9880

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 837624562@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 13750760025@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省嘉兴市中环南路1882号

研究负责人通讯地址：

浙江省嘉兴市中环南路1882号

Applicant address：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

Study leader's address：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

嘉兴市第一医院（嘉兴大学附属医院）

Applicant's institution：

The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University)

研究负责人所在单位：

嘉兴市第一医院

Affiliation of the Leader：

The First Hospital of Jiaxing

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024-LY-622

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

嘉兴市第一医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First Hospital of Jiaxing

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-08-02 00:00:00

伦理委员会联系人：

许文

Contact Name of the ethic committee：

Wen Xu

伦理委员会联系地址：

浙江省嘉兴市中环南路1882号

Contact Address of the ethic committee：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 573 89976378

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xwkikimi@163.com

研究实施负责（组长）单位：

嘉兴市第一医院

Primary sponsor：

The First Hospital of Jiaxing

研究实施负责（组长）单位地址：

浙江省嘉兴市中环南路1882号

Primary sponsor's address：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

嘉兴市第一医院

具体地址：

浙江省嘉兴市中环南路1882号

Institution
hospital：

The First Hospital of Jiaxing

Address：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

经费或物资来源：

浙江省医药卫生科技计划项目

Source(s) of funding：

Medical Scientifc Research Foundation of Zhejiang Province

研究疾病：

艾滋病  

Target disease：

AIDS

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本项目在前期工作基础上，深入研究自我管理生态圈网络系统在艾滋病感染者的自我管理行为的临床应用效果，具体目标包括: （1）技术目标：基于(Integrated Theory of Health Behavior Change, ITHBC)，以需求为导向，依托信息化研发艾滋病感染者自我管理生态圈系统。 （2）验证自我管理生态圈网络系统对自我管理能力的效果：纳入研究对象的系统使用率达到80%，艾滋病感染者自我管理能力提升10%，服药依从性较前提高10%。  

Objectives of Study：

Based on the previous work, this project will deeply study the clinical application effect of the self-management ecosystem network system in the self-management behavior of people living with AIDS. The specific objectives include: (1) Technical goal: Based on the integrated theory of health behavior change (ithbc), demand-oriented, relying on information technology to develop the self-management ecosystem system for people living with AIDS. (2) To verify the effect of self-management ecosystem network system on self-management ability: the utilization rate of the system included in the study reached 80%, the self-management ability of AIDS infected people increased by 10%, and the medication compliance increased by 10%.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.符合指南临床诊断标准；
2.年龄≥18 岁；
3.生活能够自理；
4.接受随访管理；
5.具有良好的沟通理解能力；
6.能够使用网络；
7.自愿参与，知情同意；

Inclusion criteria

1.Meets clinical diagnostic criteria according to guidelines; 2.Age>= 18 years; 3.Being able to take care of oneself in daily life; 4.Accept follow-up management; 5.Have good communication and understanding skills; 6.Ability to use the internet; 7.Voluntary participation and informed consent;

排除标准：

1.有严重并发症；
2.患有恶性肿瘤；
3.认知功能障碍或不能配合者；
4.中途退出研究者；

Exclusion criteria：

1.Have serious complications;
2.Suffering from malignant tumor;
3.Cognitive impairment or inability to cooperate;
4.Drop out researcher;

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-01 00:00:00 至 To 2027-01-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 44

Group：

Control group

Sample size：

干预措施：

医院常规管理

干预措施代码：

Intervention：

Hospital routine management

Intervention code：

组别：

试验组

样本量：

 44

Group：

Experimental Group

Sample size：

干预措施：

自我管理生态圈网络系统管理

干预措施代码：

Intervention：

Self-management Ecosystem Network System Management

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 嘉兴市第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Hospital of Jiaxing

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自我管理能力

指标类型：

主要指标

Outcome：

Self-management ability

Type：

Primary indicator

测量时间点：

干预前（入组时）、干预1个月、6个月后

测量方法：

采用伍春艳等编制的艾滋病感染者疾病自我管理量表评价

Measure time point of outcome：

Before intervention (at enrollment), 1 month after intervention, and 6 months after intervention

Measure method：

Evaluation using the HIV infection self-management scale developed by Wu Chunyan et al.

指标中文名：

免疫指标

指标类型：

次要指标

Outcome：

Immune indicator monitoring

Type：

Secondary indicator

测量时间点：

干预前（入组时）、干预1个月、6个月后

测量方法：

对患者进行免疫实验室标本监测，记录患者CD4、CD8计数与各时间点病毒载量。

Measure time point of outcome：

Before intervention (at enrollment), 1 month after intervention, and 6 months after intervention

Measure method：

The patients' immune laboratory specimens were monitored, and the CD4 and CD8 counts and viral loads at each time point were recorded.

指标中文名：

服药依从性评价

指标类型：

主要指标

Outcome：

Medication compliance evaluation

Type：

Primary indicator

测量时间点：

干预前（入组时）、干预1个月、6个月后

测量方法：

半年内能坚持服药且配合治疗者属于完全依从；半年内未漏服药物或仅漏服＜3次则是基本依从；半年内存在中断治疗或是漏服药物≥3 次，则归入不依从范围

Measure time point of outcome：

Before intervention (at enrollment), 1 month after intervention, and 6 months after intervention

Measure method：

Those who can take medication and cooperate with treatment within six months are considered fully compliant; those who do not miss medication or only miss less than 3 times within six months are considered basically compliant; those who interrupt treatment or miss ≥ 3 times within six months are considered non-compliant

指标中文名：

艾滋病机会性感染发生率

指标类型：

次要指标

Outcome：

Incidence of opportunistic infections associated with AIDS

Type：

Secondary indicator

测量时间点：

干预前（入组时）、干预1个月、6个月后

测量方法：

结核病卡氏肺囊虫肺炎、卡氏肺囊虫肺炎巨细胞病毒感染、隐球菌性脑膜炎、弓形虫病、口腔和食管念珠菌病发生情况

Measure time point of outcome：

Before intervention (at enrollment), 1 month after intervention, and 6 months after intervention

Measure method：

Incidence of tuberculosis, Pneumocystis carinii pneumonia, Pneumocystis carinii pneumonia with cytomegalovirus infection, cryptococcal meningitis, toxoplasmosis, and oral and esophageal candidiasis.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

根据88例艾滋病感染者的入院时间进行编号，从随机数字表中的任意行连续选取88个随机数字，将随机数字按从小到大的顺序进行编号，如果随机数相同，则后出现的为大。设定编号1~44为观察组，45~88为对照组，随机分组完成，两组受试者之间均衡可比。

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the admission time of 88 AIDS infected people, 88 random numbers were selected from any row in the random number table, and the random numbers were numbered from small to large. If the random numbers were the same, the later ones were larger. Set numbers 1-44 as the observation group, and 45-88 as the control group. They were randomly divided into two groups. The two groups of subjects were balanced and comparable.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

论文发表后半年内，通过备案系统网址共享数据https://www.medicalresearch.org.cn/。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Within six months of publication, share data via the filing system website https://www.medicalresearch.org.cn/.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据采集采用自行设计的调查表，向患者介绍平台的主要功能，知情同意者现场指导注册，完善个人信息，建立健康档案。分别于干预前（入组时）、干预1个月、6个月后进行问卷调查，告知患者调查目的及隐私保护，对各条目不过多的解释与评价，保证调查问卷的真实、客观，提交的问卷系统自动识别有无漏项、缺失项等，保证问卷填写正确。并进行定期随访，由经过培训的项目成员，每3日进行电话随访，询问患者使用情况并提醒数据记录的必要性。数据管理由专门的研究人员在平台更新管理。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection was conducted using a self-designed questionnaire. Patients were introduced to the platform's main functions, and those who provided informed consent were guided on-site to register, complete their personal information, and establish health records. Questionnaires were administered before intervention (at enrollment), and at 1 and 6 months after intervention. Patients were informed of the survey purpose and privacy protection. No excessive explanation or interpretation was provided for individual items to ensure the authenticity and objectivity of responses. Submitted questionnaires were automatically checked by the system for missing or incomplete entries to ensure accurate completion. Regular follow-ups were conducted by trained project staff, who made phone calls every three days to inquire about patients' usage and remind them of the importance of data recording. Data management was handled by dedicated research personnel who updated and managed the platform.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-02-04 16:18:48