NCT03984136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,008

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

June 9, 2019

Last Update Submit

June 15, 2021

Conditions

HIV/AIDS

Keywords

HIV testingMen who have sex with men

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (24)

  • Number of participants with sexually transmitted diseases (STDs) testing

    Enrollment time

  • Number of participants with sexually transmitted diseases (STDs) testing

    3 months after enrollment

  • Number of participants with sexually transmitted diseases (STDs) testing

    6 months after enrollment

  • Number of participants with sexually transmitted diseases (STDs) testing

    9 months after enrollment

  • Sexual behaviors in the past three months

    Enrollment time

  • +19 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Behavioral: COHIV without exchange mechanism

Interventions

COHIV with exchange mechanismBEHAVIORAL

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.

Intervention group
COHIV without exchange mechanismBEHAVIORAL

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.

Control group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lingnan Partner Community Support Centre

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37155223DERIVED

  • 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.

    PMID: 34362323DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHomosexuality

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Chun Hao, PhD

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Chun Hao, PhD

CONTACT

020-87334892haochun@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of School of Public Health, Sun Yat-sen University

Study Record Dates

First Submitted

June 9, 2019

First Posted

June 12, 2019

Study Start

September 27, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

The individual participant data that underlie the results in the published article would be available from the principal investigator on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

CN(1)