Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05484895 |
| Other study ID # |
STUDY00005966 |
| Secondary ID |
R01MH123352 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
January 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Emory University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
