跳至主要内容
临床试验/NCT03984136
NCT03984136Unknown不适用

The Effectiveness of HIV Results Exchange Mechanism on Promoting Testing Behavior Among Men Who Have Sex With Men: A Cluster Randomized Controlled Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,008 人开始时间: 2019年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,008
试验地点
1
主要终点
Number of participants with clinic-based HIV testing services (HTS) in the past three months

研究概览

简要总结

This will be a two-arm cluster randomized controlled trial. The control group can share their Center for Disease Control and Prevention certified online HIV results (COHIV) with another party freely through a social networking tool, while the intervention group will be asked for the COHIV before he can see the COHIV of his friend. The investigators hypothesize that the requires exchange will promote HIV testing and thus reduce HIV incidence among MSM.

详细描述

This will be a two-arm cluster randomized controlled trial. A WeChat-based mini program has been developed to send and receive Center for Disease Control and Prevention certified online HIV results (COHIV). WeChat is the ubiquitous communication and social networking tool in China. We will use the social network method for participant recruitment. A social network consists of one ego and some alters, and in this study a social network will be considered as a cluster. In a social network, ego is the MSM who shares his certified HIV test results with or without exchange mechanism by the WeChat mini program, while alters are recipients of the shared links. So the ego can shares his COHIV with many alters. After an ego shares the certified HIV test result with exchange mechanism (intervention group) or without exchange mechanism (control group) with their WeChat contactors, the people who click the link will be candidate alters in our study. 1020 alters will be recruited as the participants and the randomization would be based on the unit of social network, which means the alters will be randomized into the same group that the ego is in.

Participants in the intervention group will receive his friend's COHIV and can only open it when the participants share their own in exchange. If the participant already has the COHIV, the system will lead the user to send his COHIV to the friend. If the participant does not have the COHIV, the system will guide him to make online appointment at the testing clinic. The participants in the control group will be able to receive and open the friend's COHIV entirely at the friend's discretion without the mandatory exchange requirement. The system will also guide users on how to get an HIV test by making appointments with the MSM friendly clinics in the mini program. Questionnaires are scheduled at baseline, month 3, 6 and 9. Follow-up questionnaires will be delivered through WeChat. The primary outcome is HIV testing rate of the participants in the past three months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • •Aged more than18 years old
  • •Had anal sex with men
  • •HIV unknown or negative
  • •Plan to live in Guangzhou for the next year

排除标准

  • •Cannot complete questionnaire survey due to difficulty in reading or communication

研究组 & 干预措施

Intervention group

Experimental

Men will be required to exchange the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends conditionally.

干预措施: COHIV with exchange mechanism (Behavioral)

Control group

Active Comparator

Men will share the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends freely without conditional exchange requirement.

干预措施: COHIV without exchange mechanism (Behavioral)

结局指标

主要结局

Number of participants with clinic-based HIV testing services (HTS) in the past three months

时间窗: 9 months after enrollment

Clinic-based HTS will be measured by the objectively recorded HIV testing at the HIV clinic which will be captured real-time through the computer system.

Number of participants with self-reported HIV testing in the past three months

时间窗: 9 months after enrollment

Self-reported HIV testing includes any classification of HIV testing, will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV self-testing(HIVST) in the past three months

时间窗: 9 months after enrollment

HIVST will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV testing in the past three months

时间窗: Enrollment time

Self-reported HIV testing includes any classification of HIV testing, will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV testing in the past three months

时间窗: 3 months after enrollment

Self-reported HIV testing includes any classification of HIV testing, will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV testing in the past three months

时间窗: 6 months after enrollment

Self-reported HIV testing includes any classification of HIV testing, will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV self-testing(HIVST) in the past three months

时间窗: Enrollment time

HIVST will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV self-testing(HIVST) in the past three months

时间窗: 3 months after enrollment

HIVST will be measured by self-reported data from online questionnaires.

Number of participants with self-reported HIV self-testing(HIVST) in the past three months

时间窗: 6 months after enrollment

HIVST will be measured by self-reported data from online questionnaires.

Number of participants with clinic-based HIV testing services (HTS) in the past three months

时间窗: Enrollment time

Clinic-based HTS will be measured by the objectively recorded HIV testing at the HIV clinic which will be captured real-time through the computer system.

Number of participants with clinic-based HIV testing services (HTS) in the past three months

时间窗: 3 months after enrollment

Clinic-based HTS will be measured by the objectively recorded HIV testing at the HIV clinic which will be captured real-time through the computer system.

Number of participants with clinic-based HIV testing services (HTS) in the past three months

时间窗: 6 months after enrollment

Clinic-based HTS will be measured by the objectively recorded HIV testing at the HIV clinic which will be captured real-time through the computer system.

次要结局

  • Sexual behaviors in the past three months(9 months after enrollment)
  • Risk perception of HIV in MSM community(9 months after enrollment)
  • Number of participants with sexually transmitted diseases (STDs) testing(9 months after enrollment)
  • HIV testing norms(9 months after enrollment)
  • HIV stigma(9 months after enrollment)
  • HIV report delivery(9 months after enrollment)
  • Number of participants with sexually transmitted diseases (STDs) testing(Enrollment time)
  • Number of participants with sexually transmitted diseases (STDs) testing(3 months after enrollment)
  • Number of participants with sexually transmitted diseases (STDs) testing(6 months after enrollment)
  • Sexual behaviors in the past three months(Enrollment time)
  • Sexual behaviors in the past three months(3 months after enrollment)
  • Sexual behaviors in the past three months(6 months after enrollment)
  • HIV testing norms(Enrollment time)
  • HIV testing norms(3 months after enrollment)
  • Risk perception of HIV in MSM community(3 months after enrollment)
  • HIV testing norms(6 months after enrollment)
  • HIV stigma(Enrollment time)
  • HIV stigma(3 months after enrollment)
  • HIV stigma(6 months after enrollment)
  • Risk perception of HIV in MSM community(Enrollment time)
  • Risk perception of HIV in MSM community(6 months after enrollment)
  • HIV report delivery(Enrollment time)
  • HIV report delivery(3 months after enrollment)
  • HIV report delivery(6 months after enrollment)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun Hao

Associate Professor of School of Public Health, Sun Yat-sen University

Sun Yat-sen University

研究点 (1)

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