HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984136
• Other study ID #: No.054 of ethic committee
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: Sun Yat-sen University
• Contact: Chun Hao, PhD
• Phone: 020-87334892
• Email: haochun[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of his friend. The investigators hypothesize that the requires exchange will promote HIV testing and thus reduce HIV incidence among MSM.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1008
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Lingnan Partner Community Support Centre	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment time
Primary	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.	3 months after enrollment
Primary	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.	6 months after enrollment
Primary	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.	9 months after enrollment
Primary	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.	Enrollment time
Primary	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.	3 months after enrollment
Primary	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.	6 months after enrollment
Primary	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.	9 months after enrollment
Primary	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.	Enrollment time
Primary	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.	3 months after enrollment
Primary	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.	6 months after enrollment
Primary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment
Secondary	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.	Enrollment time
Secondary	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.	3 months after enrollment
Secondary	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.	6 months after enrollment
Secondary	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.	9 months after enrollment