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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Lingnan Partner Community Support Centre
Guangzhou, Guangdong, 510060
Jie Lu, 02013760745376
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Men 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 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. Receives: Behavioral: COHIV without exchange mechanism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 Jun 2019
- Study start27 Sep 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Chun Hao, Sun Yat-sen University
- Investigators
- Chun Hao, PhD, Study chair, Sun Yat-sen University
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 37155223Shi 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03984136
- Acronym / sponsor ID
- No.054 of ethic committee
- Conditions
- HIV/AIDS
- Keywords
- HIV testing, Men who have sex with men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Center for Disease Control and Prevention
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: COHIV with exchange mechanismMen will be required to exchange the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends conditionally. |
| Control group | Active comparator | Behavioral: COHIV without exchange mechanismMen will share the Center for Disease Control and Prevention certified online HIV results (COHIV) with friends freely without conditional exchange requirement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged more than18 years old
- Had anal sex with men
- HIV unknown or negative
- Plan to live in Guangzhou for the next year
Key exclusion criteria (1 listed)
- Cannot complete questionnaire survey due to difficulty in reading or communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COHIV with exchange mechanismA 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. | Behavioural | Intervention group |
| COHIV without exchange mechanismThe 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. | Behavioural | Control group |
Primary outcome
Number of participants with self-reported HIV testing in the past three months
Time frame: 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
Time frame: 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
Time frame: 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 testing in the past three months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 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
Time frame: 9 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
Time frame: 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
Time frame: 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
Time frame: 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.
Number of participants with clinic-based HIV testing services (HTS) in the past three months
Time frame: 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.
24 secondary outcomes
Number of participants with sexually transmitted diseases (STDs) testing
Time frame: Enrollment time
Number of participants with sexually transmitted diseases (STDs) testing
Time frame: 3 months after enrollment
Number of participants with sexually transmitted diseases (STDs) testing
Time frame: 6 months after enrollment
Number of participants with sexually transmitted diseases (STDs) testing
Time frame: 9 months after enrollment
Sexual behaviors in the past three months
Time frame: Enrollment time
Sexual behaviors in the past three months
Time frame: 3 months after enrollment
Sexual behaviors in the past three months
Time frame: 6 months after enrollment
Sexual behaviors in the past three months
Time frame: 9 months after enrollment
HIV testing norms
Time frame: Enrollment time
HIV testing norms
Time frame: 3 months after enrollment
HIV testing norms
Time frame: 6 months after enrollment
HIV testing norms
Time frame: 9 months after enrollment
HIV stigma
Time frame: Enrollment time
HIV stigma
Time frame: 3 months after enrollment
HIV stigma
Time frame: 6 months after enrollment
HIV stigma
Time frame: 9 months after enrollment
Risk perception of HIV in MSM community
Time frame: Enrollment time
Risk perception of HIV in MSM community
Time frame: 3 months after enrollment
Risk perception of HIV in MSM community
Time frame: 6 months after enrollment
Risk perception of HIV in MSM community
Time frame: 9 months after enrollment
HIV report delivery
Time frame: Enrollment time
HIV report delivery
Time frame: 3 months after enrollment
HIV report delivery
Time frame: 6 months after enrollment
HIV report delivery
Time frame: 9 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Derived from this study: PubMed 37155223Sun 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.
- Derived from this study: PubMed 34362323Shi 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.
- Individual participant dataSharing planned: Yes. The individual participant data that underlie the results in the published article would be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Hao, PhD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
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.