Today is 2014-10-23

A Personal Effective Programme to Prevent HIV among Female Sex Workers in Hong Kong

注册号:

Registration number:

ChiCTR-PRC-13003091 

注册号获得时间:

Date of releasing the registration number:

2013/03/05 

注册号状态:

预注册 

Registration Status:

Prospective registration 

注册题目:

 

Public title:

A Personal Effective Programme to Prevent HIV among Female Sex Workers in Hong Kong 

研究课题的正式科学名称:

 

Scientific title:

A Novel Approach to HIV Prevention: A Randomised Controlled Trial of Personal Effective Programme for Female Sex Workers in Hong Kong 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

 

研究负责人:

 

Applicant:

Winnie Yuen 

Study leader:

William Chi-Wai Wong 

申请注册联系人电话:

Applicant telephone:

+852 25534514 

研究负责人电话:

Study leader's telephone:

+852 25185650 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+852 28147475 

申请注册联系人电子邮件:

Applicant E-mail:

h1094178@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

wongwcw@hku.hk 

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:

 

研究负责人通讯地址:

 

Applicant address:

3/F., Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong. 

Study leader's address:

3/F., Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong. 

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:

 

Applicant's institution:

Department of Family Medicine & Primary Care, The University of Hong Kong 

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:

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:

 

Name of the ethic committee:

Institutional Review Board o the University of Hog Kong/ Hospital Authority Hong Kong West Cluster 

伦理委员会批准日期:

Date of approved by ethic committee:

2012/05/14 

研究实施负责(组长)单位:

 

Primary sponsor:

Council for the AIDS Trust Fund 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

Secretariat, Council for the AIDS Trust Fund, c/o Programme Management and Professional Development Branch, Centre for Health Promotion, Department of Health, 4/F, 147C Argyle Street, HK 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

具体地址:

Institution
hospital:

local NGOs

Address:

经费或物资来源:

 

Source(s) of funding:

AIDS Trust Fund 

研究疾病:

 

Target disease:

HIV/AIDS 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

 

Objectives of Study:

This study aims to provide evidence-based resilience-promoting personal effectiveness intervention targeted at the mental health and ultimately the sexual health of FSW, and seeks new direction in HIV prevention. Specifically, it will: • Develop and evaluate a culturally-adapted and target-specific personal effectiveness intervention as a prevention of psychological distress and HIV infection amongst FSW in Hong Kong; • Investigate the mechanism of how individual resilience factors operate to promote better psychological outcomes in FSW 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

 

Inclusion criteria

(1) 18 years or older; (2) admittedly been living and working as a FSW in Hong Kong for previous 6 months; and (3) able to give an informed consent. 

排除标准:

 

Exclusion criteria:

(1) unable to speak Cantonese/ Putonghua; and (2) self-report to have a diagnosis with and currently on treatment for a serious mental health problem such as schizophrenia, bipolar or severe anxio-depressive disorder. 

研究实施时间:

Study execute time:

From2013-6-1To 2014-6-30 

干预措施:

Interventions:

组别:

样本量:

120

Group:

Intervention vs Control

Sample size:

干预措施:

干预措施代码:

Intervention:

resilience-promoting personal effectiveness intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

local NGOs 

Level of the institution:

NA 

测量指标:

Outcomes:

指标中文名:

Outcome:

Resilience score

指标中文名:

Outcome:

scores on perceived stress, self-esteem, self-efficacy, coping, and risk behaviours (e.g. substance

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Questionnaires data

Tissue:

人体标本去向

使用后保存

说明

Fate of sample:

Preservation after use

Note:

Scores on questionnaires, session notes, and other demographic information obtained will be stored in a locked cabinet for 5 years

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 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

女性

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

one of the investigators performed block randomisation at online randomisation geeration (www.random

Gender:

Female

盲法:

Blinding:

open-label

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

Department of Family Medicine and Primary Care, The University of Hong Kong

资料管理单位:

Data management Institution:

Department of Family Medicine and Primary Care, The University of Hong Kong

资料分析单位:

Data analysis Institution:

Department of Family Medicine and Primary Care, The University of Hong Kong

创建人:

Creater Name:

Winnie Yuen 2013/3/5 14:16:17
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