Mobile Health Intervention to Increase HIV Testing and Linkage to Care

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Control condition; Behavioral: WeTest-WeLink

• Registration Number: NCT05484895
• Lead Sponsor: Emory University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-30
• Study First Posted: 2022-08-02
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control condition	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.
WeTest-WeLink intervention	WeTest-WeLink	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing HIV Self-Testing	Months 6, 12, and 18	HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Receiving Receipt of HIV Confirmatory Test	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; (ii) confirmation of attendance at an initial HIV care appointment with a local provider; and (iii) confirmation of a CD4 and HIV viral load test.
Number of Participants Attending Initial HIV Care Appointment	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.
Number of Participants With HIV Laboratory Test Results	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.

Trial Locations

Locations (3)

Wuhan Centers for Disease Control and Prevention; 🇨🇳 Wuhan, Hubei, China

Suzhou Centers for Disease Control and Prevention; 🇨🇳 Suzhou, Jiangsu, China

Chengdu Tongle Health Counselling Service Center; 🇨🇳 Chengdu, Sichuan, China