Clinical trial NCT05484895: Mobile Health Intervention to Increase HIV Testing and Linkage to Care
Official title: Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk Men in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV self-testing
Mobile Health
Men who have sex with men
Linkage to care
China
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Anhui Medical University
name: Rutgers University
name: University of Arkansas
name: National Institute of Mental Health (NIMH)
First posted: 2022-08-02
Enrollment: 1800
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Completing HIV Self-Testing
timeFrame: Months 6, 12, and 18
Secondary outcomes:
measure: Number of Participants Receiving Receipt of HIV Confirmatory Test
timeFrame: Months 6, 12, and 18
measure: Number of Participants Attending Initial HIV Care Appointment
timeFrame: Months 6, 12, and 18
measure: Number of Participants With HIV Laboratory Test Results
timeFrame: Months 6, 12, and 18
Other outcomes:
measure: Number of Participants Reporting Condomless Anal Sex
timeFrame: Months 6, 12, and 18
measure: Number of Participants Using HIV Prevention Services
timeFrame: Months 6, 12, and 18
measure: Number of Participants Reporting Substance Use
timeFrame: Months 6, 12, and 18
Locations:
city: Wuhan
country: China
facility: Wuhan Centers for Disease Control and Prevention
state: Hubei
city: Suzhou
country: China
facility: Suzhou Centers for Disease Control and Prevention
state: Jiangsu
city: Chengdu
country: China
facility: Chengdu Tongle Health Counselling Service Center
state: Sichuan
Study officials:
affiliation: Emory University
name: Don Operario, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Cui Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: