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HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM

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ClinicalTrials.gov Identifier: NCT03984136
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Guangzhou Center for Disease Control and Prevention
Information provided by (Responsible Party):
Chun Hao, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE June 9, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE September 27, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • Self-reported HIV testing rate in the past 3 months [ Time Frame: Month 3 after enrolment ]
    Measured by self-reported data
  • Self-reported HIV testing rate in the past 3 months [ Time Frame: Month 6 after enrolment ]
    Measured by self-reported data
  • Objectively recorded HIV testing rate at the HIV clinic in the past 3 months [ Time Frame: Month 3 after enrolment ]
    This will be measured by the objectively recorded HIV testing at the HIV clinic and the clinic-based HIV testing will be captured real-time through the computer system
  • Objectively recorded HIV testing rate at the HIV clinic in the past 3 months [ Time Frame: Month 6 after enrolment ]
    This will be measured by the objectively recorded HIV testing at the HIV clinic and the clinic-based HIV testing will be captured real-time through the computer system
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Self-reported HIV testing rate among the participants in the past 3 months [ Time Frame: Month 3 after enrolment ]
    This will be measured by self-reported HIV testing and the self-reported HIV testing will be collected through WeChat-sent questionnaire at baseline and 3-month after the program launch.
  • Objectively recorded HIV testing rate at the HIV clinic in the past 3 months [ Time Frame: Month 3 after enrolment ]
    This will be measured by the objectively recorded HIV testing at the HIV clinic and the clinic-based HIV testing will be captured real-time through the computer system
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • The sexually transmitted diseases (STD) testing rate [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data
  • The number of sex partners [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data
  • The number of unprotected anal sex [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data
  • HIV stigma [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by a 7-item version of the HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future. All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate greater stigma.
  • The rates of HIV infection [ Time Frame: Month 6 after enrolment ]
    Measured by self-reported data
  • HIV testing social norms [ Time Frame: Baseline and month 3/6 after enrolment ]
    HIV testing social norms will be measured using six survey items that are each on a four-point Likert scale. All six items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate less positive HIV testing social norms.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • The rate of self-repoted first time HIV testing among the participants [ Time Frame: Month 3 after enrolment ]
    This will be measured by self-reported HIV testing and the self-reported HIV testing will be collected through WeChat-sent questionnaire at baseline and 3-month after the program launch.
  • The rate of objectively recorded first time HIV testing among the participants [ Time Frame: Month 3 after enrolment ]
    This will be measured by the objectively recorded HIV testing at the HIV clinic and the clinic-based HIV testing will be captured real-time through the computer system
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
Official Title  ICMJE The Effectiveness of HIV Results Exchange Mechanism on Promoting Testing Behavior Among Men Who Have Sex With Men: A Cluster Randomized Controlled Trial
Brief Summary 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.
Detailed Description

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 and 6. Follow-up questionnaires will be delivered through Wechat. The primary outcome is HIV testing rate of the participants in the past three months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • Behavioral: COHIV with exchange mechanism
    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. Participants in the intervention group will receive his friend's COHIV only 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.
  • Behavioral: COHIV without exchange mechanism
    The participants in the control group will be able to receive the friend's Center for Disease Control and Prevention certified online HIV results (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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Men will be required to exchange the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends conditionally.
    Intervention: Behavioral: COHIV with exchange mechanism
  • Active Comparator: Control group
    Men will share the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends freely without conditional exchange requirement.
    Intervention: Behavioral: COHIV without exchange mechanism
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
1020
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chun Hao, PhD 020-87334892 haochun@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984136
Other Study ID Numbers  ICMJE No.054 of ethic committee
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The individual participant data that underlie the results in the published article would be available from the principal investigator on reasonable request.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal.
Responsible Party Chun Hao, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Guangzhou Center for Disease Control and Prevention
Investigators  ICMJE
Study Chair: Chun Hao, PhD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP