Mobile Health Intervention to Increase HIV Testing and Linkage to Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: WeTest-WeLink
* Behavioral: Control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WeTest-WeLink intervention<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* Contact information of local NGO for emergency referrals; free additional HST.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Number of Participants Receiving Receipt of HIV Confirmatory Test | 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. | Months 6, 12, and 18 | 
| Change in the Number of Participants Attending Initial HIV Care Appointment | 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. | Months 6, 12, and 18 | 
| Change in the Number of Participants With HIV Laboratory Test Results | 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. | Months 6, 12, and 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV self-testing, Mobile Health, Men who have sex with men, Linkage to care, China