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HIV/AIDSNCT03984136

HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM

A study testing COHIV with exchange mechanism and COHIV without exchange mechanism in people with HIV/AIDS, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
HIV/AIDS
What is being tested?
COHIV with exchange mechanism and COHIV without exchange mechanism
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,008 participants
Where
1 siteChina
Study dates
27 Sep 2019to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Lingnan Partner Community Support Centre

    Guangzhou, Guangdong, 510060

    Jie Lu, 02013760745376

    Recruiting

Other trials in China

About this study

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

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.

Read the 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, 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.

Conditions
HIV/AIDS
Being tested
COHIV with exchange mechanism, COHIV without exchange mechanism
Keywords
HIV testing, Men who have sex with men
Medical subject headings
Acquired Immunodeficiency Syndrome, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COHIV with exchange mechanismBehavioural

    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.

  • COHIV without exchange mechanismBehavioural

    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 groups in NCT03984136
Study groupRoleWhat they receive
Intervention groupExperimentalMen will be required to exchange the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends conditionally.
Receives: Behavioral: COHIV with exchange mechanism
Control groupActive comparatorMen will share the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends freely without conditional exchange requirement.
Receives: Behavioral: COHIV without exchange mechanism

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Enrollment time

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

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

    Measured: 3 months after enrollment

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

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

    Measured: 6 months after enrollment

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

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

    Measured: 9 months after enrollment

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

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

    Measured: Enrollment time

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

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

    Measured: 3 months after enrollment

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

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

    Measured: 6 months after enrollment

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

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

    Measured: 9 months after enrollment

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

    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.

    Measured: Enrollment time

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

    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.

    Measured: 3 months after enrollment

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

    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.

    Measured: 6 months after enrollment

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

    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.

    Measured: 9 months after enrollment

Secondary outcomes (24)
  1. Number of participants with sexually transmitted diseases (STDs) testing

    Sexually transmitted diseases (STDs) testing will be measured by self-reported data from online questionnaires and registered data in the HIV testing system.

    Measured: Enrollment time

  2. Number of participants with sexually transmitted diseases (STDs) testing

    Sexually transmitted diseases (STDs) testing will be measured by self-reported data from online questionnaires and registered data in the HIV testing system.

    Measured: 3 months after enrollment

  3. Number of participants with sexually transmitted diseases (STDs) testing

    Sexually transmitted diseases (STDs) testing will be measured by self-reported data from online questionnaires and registered data in the HIV testing system.

    Measured: 6 months after enrollment

  4. Number of participants with sexually transmitted diseases (STDs) testing

    Sexually transmitted diseases (STDs) testing will be measured by self-reported data from online questionnaires and registered data in the HIV testing system.

    Measured: 9 months after enrollment

  5. Sexual behaviors in the past three months

    High-risk and protective sexual behaviors include regular or casual sex partners; request for disclosure of HIV status before sex in the past 3 months; unprotected anal intercourse (UAI) with sex partners in the past 3 months; HIV testing service appointment and HIV test results, will be measured by self-reported data from online questionnaires and the routinely collect data in the HIV testing service system.

    Measured: Enrollment time

  6. Sexual behaviors in the past three months

    High-risk and protective sexual behaviors include regular or casual sex partners; request for disclosure of HIV status before sex in the past 3 months; unprotected anal intercourse (UAI) with sex partners in the past 3 months; HIV testing service appointment and HIV test results, will be measured by self-reported data from online questionnaires and the routinely collect data in the HIV testing service system.

    Measured: 3 months after enrollment

  7. Sexual behaviors in the past three months

    High-risk and protective sexual behaviors include regular or casual sex partners; request for disclosure of HIV status before sex in the past 3 months; unprotected anal intercourse (UAI) with sex partners in the past 3 months; HIV testing service appointment and HIV test results, will be measured by self-reported data from online questionnaires and the routinely collect data in the HIV testing service system.

    Measured: 6 months after enrollment

  8. Sexual behaviors in the past three months

    High-risk and protective sexual behaviors include regular or casual sex partners; request for disclosure of HIV status before sex in the past 3 months; unprotected anal intercourse (UAI) with sex partners in the past 3 months; HIV testing service appointment and HIV test results, will be measured by self-reported data from online questionnaires and the routinely collect data in the HIV testing service system.

    Measured: 9 months after enrollment

  9. HIV testing norms

    HIV testing norms are measured using six survey items that are each on a four-point Likert scale in online surveys. 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.

    Measured: Enrollment time

  10. HIV testing norms

    HIV testing norms are measured using six survey items that are each on a four-point Likert scale in online surveys. 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.

    Measured: 3 months after enrollment

  11. HIV testing norms

    HIV testing norms are measured using six survey items that are each on a four-point Likert scale in online surveys. 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.

    Measured: 6 months after enrollment

  12. HIV testing norms

    HIV testing norms are measured using six survey items that are each on a four-point Likert scale in online surveys. 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.

    Measured: 9 months after enrollment

  13. HIV stigma

    HIV stigma will be measured by a 7-item version of the HIV stigma scale, designed to measure the extent to which participants anticipated negative interpersonal 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.

    Measured: Enrollment time

  14. HIV stigma

    HIV stigma will be measured by a 7-item version of the HIV stigma scale, designed to measure the extent to which participants anticipated negative interpersonal 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.

    Measured: 3 months after enrollment

  15. HIV stigma

    HIV stigma will be measured by a 7-item version of the HIV stigma scale, designed to measure the extent to which participants anticipated negative interpersonal 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.

    Measured: 6 months after enrollment

  16. HIV stigma

    HIV stigma will be measured by a 7-item version of the HIV stigma scale, designed to measure the extent to which participants anticipated negative interpersonal 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.

    Measured: 9 months after enrollment

  17. Risk perception of HIV in MSM community

    Risk perception of HIV in MSM community will be measured by self-perceived HIV prevalence in the circle.

    Measured: Enrollment time

  18. Risk perception of HIV in MSM community

    Risk perception of HIV in MSM community will be measured by self-perceived HIV prevalence in the circle.

    Measured: 3 months after enrollment

  19. Risk perception of HIV in MSM community

    Risk perception of HIV in MSM community will be measured by self-perceived HIV prevalence in the circle.

    Measured: 6 months after enrollment

  20. Risk perception of HIV in MSM community

    Risk perception of HIV in MSM community will be measured by self-perceived HIV prevalence in the circle.

    Measured: 9 months after enrollment

  21. HIV report delivery

    HIV report delivery includes the proportion of Egos who forward and read their reports; the proportion of Alters who receive and read egos' reports; the proportion of alters who get their own HIV reports; the proportion of forwarded report usage among MSM and the satisfaction of online HIV report service. These data will be collected by the WeChat-based data portal.

    Measured: Enrollment time

  22. HIV report delivery

    HIV report delivery includes the proportion of Egos who forward and read their reports; the proportion of Alters who receive and read egos' reports; the proportion of alters who get their own HIV reports; the proportion of forwarded report usage among MSM and the satisfaction of online HIV report service. These data will be collected by the WeChat-based data portal.

    Measured: 3 months after enrollment

  23. HIV report delivery

    HIV report delivery includes the proportion of Egos who forward and read their reports; the proportion of Alters who receive and read egos' reports; the proportion of alters who get their own HIV reports; the proportion of forwarded report usage among MSM and the satisfaction of online HIV report service. These data will be collected by the WeChat-based data portal.

    Measured: 6 months after enrollment

  24. HIV report delivery

    HIV report delivery includes the proportion of Egos who forward and read their reports; the proportion of Alters who receive and read egos' reports; the proportion of alters who get their own HIV reports; the proportion of forwarded report usage among MSM and the satisfaction of online HIV report service. These data will be collected by the WeChat-based data portal.

    Measured: 9 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start27 Sep 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,008 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03984136
Sponsor's protocol ID
No.054 of ethic committee
Status last verified
Jun 2021
First submitted
9 Jun 2019
Last updated
21 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data that underlie the results in the published article would be available from the principal investigator on reasonable request.

Publications

  • Sun HT, Fan XR, Gu YZ, Lu YH, Qiu JL, Yang QL, Li JH, Gu J, Hao C. WeChat-Based HIV e-Report, a New Approach for HIV Serostatus Requests and Disclosures Among Men Who Have Sex With Men: Prospective Subgroup Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 May 8;11:e44513. doi: 10.2196/44513.

    PubMed 37155223
  • Shi Y, Qiu J, Yang Q, Chen T, Lu Y, Chen S, Fan X, Lin Z, Han Z, Lu J, Qian H, Gu J, Xu DR, Gu Y, Hao C. Increasing the HIV testing among MSM through HIV test result exchange mechanism: study protocol for a cluster randomized controlled trial. BMC Infect Dis. 2021 Aug 6;21(1):764. doi: 10.1186/s12879-021-06484-y.

    PubMed 34362323

Questions about this trial

What is this clinical trial studying?

A study testing COHIV with exchange mechanism and COHIV without exchange mechanism in people with HIV/AIDS, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chun Hao, PhD (020-87334892, haochun@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with self-reported HIV testing in the past three months (time frame: Enrollment time). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03984136, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.

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