Clinical trial NCT03984136: HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV testing
Men who have sex with men
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Center for Disease Control and Prevention
First posted: 2019-06-12
Enrollment: 1008
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with self-reported HIV testing in the past three months
timeFrame: Enrollment time
measure: Number of participants with self-reported HIV testing in the past three months
timeFrame: 3 months after enrollment
measure: Number of participants with self-reported HIV testing in the past three months
timeFrame: 6 months after enrollment
measure: Number of participants with self-reported HIV testing in the past three months
timeFrame: 9 months after enrollment
measure: Number of participants with self-reported HIV self-testing(HIVST) in the past three months
timeFrame: Enrollment time
measure: Number of participants with self-reported HIV self-testing(HIVST) in the past three months
timeFrame: 3 months after enrollment
measure: Number of participants with self-reported HIV self-testing(HIVST) in the past three months
timeFrame: 6 months after enrollment
measure: Number of participants with self-reported HIV self-testing(HIVST) in the past three months
timeFrame: 9 months after enrollment
measure: Number of participants with clinic-based HIV testing services (HTS) in the past three months
timeFrame: Enrollment time
measure: Number of participants with clinic-based HIV testing services (HTS) in the past three months
timeFrame: 3 months after enrollment
measure: Number of participants with clinic-based HIV testing services (HTS) in the past three months
timeFrame: 6 months after enrollment
measure: Number of participants with clinic-based HIV testing services (HTS) in the past three months
timeFrame: 9 months after enrollment
Secondary outcomes:
measure: Number of participants with sexually transmitted diseases (STDs) testing
timeFrame: Enrollment time
measure: Number of participants with sexually transmitted diseases (STDs) testing
timeFrame: 3 months after enrollment
measure: Number of participants with sexually transmitted diseases (STDs) testing
timeFrame: 6 months after enrollment
measure: Number of participants with sexually transmitted diseases (STDs) testing
timeFrame: 9 months after enrollment
measure: Sexual behaviors in the past three months
timeFrame: Enrollment time
measure: Sexual behaviors in the past three months
timeFrame: 3 months after enrollment
measure: Sexual behaviors in the past three months
timeFrame: 6 months after enrollment
measure: Sexual behaviors in the past three months
timeFrame: 9 months after enrollment
measure: HIV testing norms
timeFrame: Enrollment time
measure: HIV testing norms
timeFrame: 3 months after enrollment
measure: HIV testing norms
timeFrame: 6 months after enrollment
measure: HIV testing norms
timeFrame: 9 months after enrollment
measure: HIV stigma
timeFrame: Enrollment time
measure: HIV stigma
timeFrame: 3 months after enrollment
measure: HIV stigma
timeFrame: 6 months after enrollment
measure: HIV stigma
timeFrame: 9 months after enrollment
measure: Risk perception of HIV in MSM community
timeFrame: Enrollment time
measure: Risk perception of HIV in MSM community
timeFrame: 3 months after enrollment
measure: Risk perception of HIV in MSM community
timeFrame: 6 months after enrollment
measure: Risk perception of HIV in MSM community
timeFrame: 9 months after enrollment
measure: HIV report delivery
timeFrame: Enrollment time
measure: HIV report delivery
timeFrame: 3 months after enrollment
measure: HIV report delivery
timeFrame: 6 months after enrollment
measure: HIV report delivery
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Lingnan Partner Community Support Centre
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chun Hao, PhD
role: STUDY_CHAIR
References:
citation: 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.