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Completed

NCT Number: NCT05484895

Mobile Health Intervention to Increase HIV Testing and Linkage to Care

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Centers for Disease Control and Prevention, Wuhan, Hubei, China

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About this study

The overarching goal of this 5-year research project is to advance the science of mobile health approaches to increase uptake of repeat HIV self-testing (HST) and linkage to HIV-related care with populations that underperform on these steps of the HIV care continuum. The proposed intervention is entitled "WeTest-WeLink" that builds on years of formative work with men who have sex with men (MSM) in China conducted by this team of investigators (R34MH106349), demonstrating promising effects from a pilot RCT and strong indication of intervention acceptability, feasibility, and cultural sensitivity. The intervention uses the "WeChat" mobile app platform, which offers multiple features built into the app that facilitate health information delivery and communication channels (e.g., capacity for private texts, group chats, video sharing, Global Positioning System (GPS), instant messaging, real-time audio and visual communication). Guided by the Information-Motivation-Behavioral (IMB) model and Minority Stress Theory, the study team will employ a user-centered design process to refine and expand app features to support repeat HST uptake, behavioral risk reduction, stigma coping strategies, and self-efficacy to link to HIV care. The study team will use an Effectiveness-Implementation Hybrid Type 1 design consisting of a three site, 2-arm randomized clinical trial (RCT) to test HST and linkage to HIV related care outcomes as well as qualitative research to examine implementation and scalability. The study team will recruit 1,800 HIV negative MSM. Participants will be allocated to the intervention (access to the WeTest-WeLink app) or control group (education about HST and passive referral to HIV care for individuals who test HIV positive). The study team will assess participants at 6, 12, and 18 months to measure intervention effects on primary outcomes of repeated use of HST (including photographic confirmation) and linkage to care for individuals who test HIV-positive. Secondary outcomes include sexual risk behaviors and use of HIV prevention services, and investigators will conduct mediation analysis to examine theoretical mechanisms of behavior change. The study team will qualitatively assess intervention-related process characteristics that enable and/or impede implementation and scalability informed by the Consolidated Framework for Implementation Research (CFIR). This project will provide the first known evidence for a mobile health approach to optimize both HIV testing and linkage to care as part of a single intervention continuum with MSM. Such findings can be crucial for optimizing the care cascade in populations that underutilize HIV services, such as MSM in China and elsewhere in the world where HIV testing and linkage to care services are sub-optimal.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

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

Treatment and study plan

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.

Control condition

Behavioral

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

Primary outcomes

  1. Number of Participants Completing HIV Self-Testing

    Time frame: Months 6, 12, and 18

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

Secondary outcomes

  1. Number of Participants With HIV Laboratory Test Results

    Time frame: Months 6, 12, and 18

    Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of laboratory test results of cluster of differentiation 4 (CD4) and HIV viral load.

  2. Number of Participants Attending Initial HIV Care Appointment

    Time frame: Months 6, 12, and 18

    Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of attendance at an initial HIV care appointment with a local provider.

  3. Number of Participants Receiving Receipt of HIV Confirmatory Test

    Time frame: Months 6, 12, and 18

    Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of receipt of an HIV confirmatory test.

Other outcomes

  1. Number of Participants Using HIV Prevention Services

    Time frame: Months 6, 12, and 18

    Participants are asked to report whether or not they have used any HIV prevention services.

  2. Number of Participants Reporting Substance Use

    Time frame: Months 6, 12, and 18

    HIV risk behavior is assessed by participants self-reporting alcohol or drug use prior to or during sexual episodes during the past 3 months.

  3. Number of Participants Reporting Condomless Anal Sex

    Time frame: Months 6, 12, and 18

    HIV sexual risk is assessed as participants' self-report of condomless anal sex.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Anhui Medical University
  • National Institute of Mental Health (NIMH)
  • Rutgers University
  • University of Arkansas

Registry information

Official study title

Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk Men in China

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2022
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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