A RCT Evaluating the Efficacy of Enhanced and Standard Versions of HIV Testing and Counselling Among Men Who Have Sex With Men in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Take up any type of HIV antibody testing
研究概览
简要总结
Objective The objectives of the study are to evaluate the relative efficacy of an enhanced version of HIV testing and counselling (EHTC) versus standard-of-care HIV testing and counselling (SHTC) in reducing sexual risk behaviours, increasing retesting rate and risk perception among men who have sex with men (MSM) in Hong Kong.
Participants Inclusion criteria are: 1) men of age 18 years or above using HTC services at AIDS Concern, 2) anal intercourse with at least one man in the last six months, 3) able to read and comprehend Cantonese, 4) willingness to provide contact information and to complete a simple follow up evaluation at Month 6, and 5) no intention to leave Hong Kong for one month consecutively within the next six months. Those self-reported or tested to be HIV positive will be excluded from the study.
Design A parallel-group and non-blinded randomized controlled trial (RCT) will be conducted. A total of 430 participants will be randomly allocated into the intervention group receiving EHTC (n=215) and the control group receiving SHTC (n=215). Evaluation will be performed six months afterwards.
Outcomes Primary outcomes are: 1) Prevalence of unprotected anal intercourse with any and specific types of male partners during the 6-month follow up period; 2) uptake of any type of HIV antibody testing within the 6-month follow-up period, and 3) HIV risk perception.
详细描述
Aim To evaluate the relative efficacy of an enhanced version of HIV testing and counselling (EHTC) that combines a component proven effective and new components involving e-health and HIV risk self-assessment versus standard-of-care HIV testing and counselling (SHTC) in reducing sexual risk behaviours, and increasing HIV retesting rate and risk perception among men who have sex with men (MSM) in Hong Kong.
Objectives To compare outcomes obtained from the intervention group (EHTC) and the control group (SHTC) at Month 6, including: 1) prevalence of unprotected anal intercourse with any type and specific types of male sex partners (regular and non-regular partners) in the last six months, 2) prevalence of having taken up any type of HIV antibody testing within the 6-month follow-up period, and 3) level of HIV risk perception.
Study design A parallel-group and non-blinded randomized controlled trial (RCT) will be conducted. A total of 430 participants will be randomly allocated into the intervention group receiving EHTC (n=215) and the control group receiving standard-of-care HTC (SHTC; n=215). Evaluation will be performed six month afterwards.
Recruitment procedures Users of AIDS Concern's HTC service will be approached by staff of AIDS Concern. They will brief the participants about the detail of the study and invite them to participate. Prospective participants who are interested in joining the study will be screened for their eligibility. Guarantees will be made on anonymity, right to quit at any time and that refusal will not affect their chance in using any services. Verbal instead of written informed consent will be obtained due to maintaining anonymity but the fieldworkers will sign a form pledging that the participants have been fully informed about the study.
Baseline survey and randomization Participants will complete a self-administered baseline questionnaire on site. Participants are randomized 1:1 into the intervention group and the control group. Staff of the NGO will draw one of the sealed opaque envelops to randomly allocate participants into the intervention and the control groups. Random numbers will be generated by a computer. Block randomization with block size of eight will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men of age 18 years or above taking up HIV testing and counselling (HTC) at a collaborative non-governmental organization (NGO),
- •anal intercourse with at least one man in the last six months
- •able to read and comprehend Cantonese
- •willingness to provide contact information and to complete a simple follow up evaluation at Month 6
- •no intention to leave Hong Kong for one month consecutively within the next six months.
排除标准
- •self-reported or tested to be HIV positive
结局指标
主要结局
Take up any type of HIV antibody testing
时间窗: six months
Uptake of any type of HIV antibody testing within the follow-up period will be assessed at Month 6 telephone follow-up evaluation
次要结局
- Unprotected anal intercourse with any and specific types of male partners(six months)
- Risk perception(six months)
研究者
Zixin Wang
Research Assistant Professor
Chinese University of Hong Kong