HIV
Conditions
Keywords
HIV self-testing, Mobile Health, Men who have sex with men, Linkage to care, China
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.
Interventions
BEHAVIORALWeTest-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.
BEHAVIORALControl condition
Contact information of local NGO for emergency referrals; free additional HST.
Sponsors
Emory University
Anhui Medical University
Rutgers University
University of Arkansas
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDon Operario, PhD
Emory University
PRINCIPAL_INVESTIGATORCui Yang, PhD
Rutgers University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 900 |
| 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.
Control condition: Contact information of local NGO for emergency referrals; free additional HST. | 900 |
| Total | 1,800 |
Baseline characteristics
| Characteristic | WeTest-WeLink intervention | Control | Total |
|---|---|---|---|
| Age, Customized 18-24 years | 224 Participants | 228 Participants | 452 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 25-39 years | 509 Participants | 511 Participants | 1020 Participants |
| Age, Customized >=40 years | 147 Participants | 161 Participants | 308 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 900 Participants | 900 Participants | 1800 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 900 Participants | 900 Participants | 1800 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 900 Participants | 900 Participants | 1800 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 900 Participants | 900 Participants | 1800 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 900 | 0 / 900 |
| other Total, other adverse events | 0 / 900 | 0 / 900 |
| serious Total, serious adverse events | 0 / 900 | 0 / 900 |
Outcome results
Primary
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.
Time frame: Months 6, 12, and 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| WeTest-WeLink intervention | Number of Participants Completing HIV Self-Testing | Month 6 | 878 Participants |
| WeTest-WeLink intervention | Number of Participants Completing HIV Self-Testing | Month 12 | 857 Participants |
| WeTest-WeLink intervention | Number of Participants Completing HIV Self-Testing | Month 18 | 837 Participants |
| Control | Number of Participants Completing HIV Self-Testing | Month 6 | 889 Participants |
| Control | Number of Participants Completing HIV Self-Testing | Month 12 | 875 Participants |
| Control | Number of Participants Completing HIV Self-Testing | Month 18 | 836 Participants |
Secondary
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.
Time frame: Months 6, 12, and 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| WeTest-WeLink intervention | Number of Participants Attending Initial HIV Care Appointment | Month 6 | 3 Participants |
| WeTest-WeLink intervention | Number of Participants Attending Initial HIV Care Appointment | Month 12 | 6 Participants |
| WeTest-WeLink intervention | Number of Participants Attending Initial HIV Care Appointment | Month 18 | 3 Participants |
| Control | Number of Participants Attending Initial HIV Care Appointment | Month 6 | 6 Participants |
| Control | Number of Participants Attending Initial HIV Care Appointment | Month 12 | 5 Participants |
| Control | Number of Participants Attending Initial HIV Care Appointment | Month 18 | 5 Participants |
Secondary
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.
Time frame: Months 6, 12, and 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| WeTest-WeLink intervention | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 6 | 3 Participants |
| WeTest-WeLink intervention | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 12 | 6 Participants |
| WeTest-WeLink intervention | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 18 | 3 Participants |
| Control | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 6 | 6 Participants |
| Control | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 12 | 5 Participants |
| Control | Number of Participants Receiving Receipt of HIV Confirmatory Test | Month 18 | 5 Participants |
Secondary
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.
Time frame: Months 6, 12, and 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| WeTest-WeLink intervention | Number of Participants With HIV Laboratory Test Results | Month 6 | 3 Participants |
| WeTest-WeLink intervention | Number of Participants With HIV Laboratory Test Results | Month 12 | 6 Participants |
| WeTest-WeLink intervention | Number of Participants With HIV Laboratory Test Results | Month 18 | 3 Participants |
| Control | Number of Participants With HIV Laboratory Test Results | Month 6 | 6 Participants |
| Control | Number of Participants With HIV Laboratory Test Results | Month 12 | 5 Participants |
| Control | Number of Participants With HIV Laboratory Test Results | Month 18 | 5 Participants |
Other Pre-specified
Number of Participants Reporting Condomless Anal Sex
HIV sexual risk is assessed as participants' self-report of condomless anal sex.
Time frame: Months 6, 12, and 18
Other Pre-specified
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.
Time frame: Months 6, 12, and 18
Other Pre-specified
Number of Participants Using HIV Prevention Services
Participants are asked to report whether or not they have used any HIV prevention services.
Time frame: Months 6, 12, and 18