Mobile Health Intervention to Increase HIV Testing and Linkage to Care

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: WeTest-WeLink; Behavioral: Control condition

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 Type: Interventional
• Enrollment (Actual): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Centers for Disease Control and Prevention
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Suzhou Centers for Disease Control and Prevention
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Tongle Health Counselling Service Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Number of Participants Reporting Condomless Anal Sex	HIV sexual risk is assessed as participants' self-report of condomless anal sex.	Months 6, 12, and 18
Change in the Number of Participants Using HIV Prevention Services	Participants are asked to report whether or not they have used any HIV prevention services.	Months 6, 12, and 18
Change in the Number of Participants Reporting Substance Use	HIV risk behavior is assessed by participants self-reporting alcohol or drug use prior to or during sexual episodes during the past 3 months.	Months 6, 12, and 18

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH); University of Arkansas; Rutgers University; Anhui Medical University
• Investigators: Principal Investigator: Don Operario, PhD, Emory University; Principal Investigator: Cui Yang, PhD, Rutgers University; Principal Investigator: Nickolas Zaller, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: China; Mobile Health; Men who have sex with men; HIV self-testing; Linkage to care
• Other Study ID Numbers: STUDY00005966; R01MH123352 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified datasets and a comprehensive data dictionary will be made available for sharing with other researchers.
• IPD Sharing Time Frame: Data will be available for sharing after data analysis for this study is complete.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No