Mobile Health Intervention to Increase HIV Testing and Linkage to Care

NCT05484895 | Completed Results DMC

• 2 other identifiers: STUDY00005966R01MH123352
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 3

Brief Summary

This 5-year project will test an mobile health approach to improve HIV self-testing (HST) and linkage to HIV-related care among high-risk men in China. HIV-negative men who have sex with men (MSM) will be randomly assigned to an intervention group: access to WeTest-WeLink (a mobile application-based HIV testing health promotion and risk reduction program), or a control group. Participant HST and sexual risk behaviors will be evaluated at baseline and at 6, 12, and 18 months post-baseline.

Conditions

HIV

Keywords

HIV self-testing; Mobile Health; Men who have sex with men; Linkage to care; China

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completing HIV Self-Testing

  HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.

  Months 6, 12, and 18

Secondary Outcomes (3)

• Number of Participants With HIV Laboratory Test Results

  Months 6, 12, and 18

• Number of Participants Attending Initial HIV Care Appointment

  Months 6, 12, and 18

• Number of Participants Receiving Receipt of HIV Confirmatory Test

  Months 6, 12, and 18

Other Outcomes (3)

• Number of Participants Using HIV Prevention Services

  Months 6, 12, and 18

• Number of Participants Reporting Substance Use

  Months 6, 12, and 18

• Number of Participants Reporting Condomless Anal Sex

  Months 6, 12, and 18

Study Arms (2)

WeTest-WeLink intervention

EXPERIMENTAL

Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.

Behavioral: WeTest-WeLink

Control

ACTIVE COMPARATOR

Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.

Behavioral: Control condition

Interventions

WeTest-WeLink BEHAVIORAL

"WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.

WeTest-WeLink intervention

Control condition BEHAVIORAL

Contact information of local NGO for emergency referrals; free additional HST.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Chinese
• Cis-gender male
• Condomless anal sex with another man in the past 6 months
• Resident in the study location for at least 6 months and no desire to relocate during the study period
• In possession of a mobile "smart" phone with capability to download and use WeChat
• HIV-negative (verified through HIV self-test at enrollment)
• Able to give informed consent

You may not qualify if:

• HIV positive at enrollment
• Self-report coercion to participate

Sponsors & Collaborators

• Emory University: lead
• Anhui Medical University: collaborator
• Rutgers University: collaborator
• University of Arkansas: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Wuhan Centers for Disease Control and Prevention

Wuhan, Hubei, China

Location

Suzhou Centers for Disease Control and Prevention

Suzhou, Jiangsu, China

Location

Chengdu Tongle Health Counselling Service Center

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Dr. Don Operario
• Organization: Emory University

don.operario@emory.edu

404-727-0503

Study Officials

• Don Operario, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Cui Yang, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention involves demonstration of HIV self-testing and access to a mobile health application to promote HIV self-testing, HIV behavioral risk reduction, and linkage to care

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: December 15, 2021
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available for sharing after data analysis for this study is complete.
• Access Criteria: Data will be made available for sharing with researchers, community-based organizations, and advisory committees for the purposes of secondary descriptive or exploratory analysis. Researchers interested in using this data can contact the study PI, Dr. Operario, at don.operario@emory.edu with a brief explanation of the planned analysis.

Locations

CN (3)