Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984136
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Guangzhou Center for Disease Control and Prevention
Information provided by (Responsible Party):
Chun Hao, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: COHIV with exchange mechanism Behavioral: COHIV without exchange mechanism Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effectiveness of HIV Results Exchange Mechanism on Promoting Testing Behavior Among Men Who Have Sex With Men: A Cluster Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention group
Men will be required to exchange the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends conditionally.
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.

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.
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.




Primary Outcome Measures :
  1. Self-reported HIV testing rate in the past 3 months [ Time Frame: Month 3 after enrolment ]
    Measured by self-reported data

  2. Self-reported HIV testing rate in the past 3 months [ Time Frame: Month 6 after enrolment ]
    Measured by self-reported data

  3. 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

  4. 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


Secondary Outcome Measures :
  1. The sexually transmitted diseases (STD) testing rate [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data

  2. The number of sex partners [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data

  3. The number of unprotected anal sex [ Time Frame: Baseline and month 3/6 after enrolment ]
    Measured by self-reported data

  4. 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.

  5. The rates of HIV infection [ Time Frame: Month 6 after enrolment ]
    Measured by self-reported data

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years old
  • Had anal sex with men
  • HIV unknown or negative
  • Plan to live in Guangzhou for the next year

Exclusion Criteria:

  • Already clicked a similar WeChat-based HIV report link before recruitment
  • Had an HIV test in the past 3 months
  • Cannot complete questionnaire survey due to difficulty in reading or communication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984136


Contacts
Layout table for location contacts
Contact: Chun Hao, PhD 020-87334892 haochun@mail.sysu.edu.cn

Locations
Layout table for location information
China, Guangdong
School of Public Health, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chun Hao, PhD    020-87334892    haochun@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou Center for Disease Control and Prevention
Investigators
Layout table for investigator information
Study Chair: Chun Hao, PhD Sun Yat-sen University

Layout table for additonal information
Responsible Party: Chun Hao, Associate Professor of School of Public Health, Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03984136     History of Changes
Other Study ID Numbers: No.054 of ethic committee
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chun Hao, Sun Yat-sen University:
HIV testing
Men who have sex with men