Trial results for a mobile health intervention aimed at increasing HIV testing and linkage to care were posted on ClinicalTrials.gov on 2025-11-05, involving 1800 participants.
Background
Human Immunodeficiency Virus (HIV) remains a significant global health challenge, with early detection and linkage to care being critical for effective treatment and prevention of transmission. Men who have sex with men (MSM) are identified as a high-risk population for HIV acquisition. Interventions that can improve HIV self-testing (HST) and facilitate subsequent linkage to care are important for public health efforts, particularly in regions like China where this study was conducted. Mobile health (mHealth) applications offer a potential avenue to reach and support these populations in a discreet and accessible manner.
Trial design
This completed study, designated as Phase NA, enrolled 1800 participants. The trial focused on HIV among HIV-negative men who have sex with men (MSM) in China. Participants were randomly assigned to either an intervention group, which received access to WeTest-WeLink (a mobile application-based HIV testing health promotion and risk reduction program), or a control group. The project aimed to test this mobile health approach to improve HIV self-testing (HST) and linkage to HIV-related care. Participant HST and sexual risk behaviors were evaluated at baseline and at 6, 12, and 18 months post-baseline.
Key results
The trial reported key measurements related to HIV self-testing and linkage to care over 18 months:
- Number of Participants Completing HIV Self-Testing:
- For the WeTest-WeLink intervention group, the number of participants completing self-testing was 878, 857, and 837 at different time points.
- For the Control group, the number of participants completing self-testing was 889, 875, and 836 at different time points.
- Number of Participants With HIV Laboratory Test Results:
- In the WeTest-WeLink intervention group, the number of participants with HIV laboratory test results was 3, 6, and 3 at different time points.
- In the Control group, the number of participants with HIV laboratory test results was 6, 5, and 5 at different time points.
What this means
The posted results provide data on the number of participants completing HIV self-testing and those with HIV laboratory test results in both the WeTest-WeLink intervention and control groups. The raw counts for HIV self-testing were comparable between the intervention and control groups across the measured time points. Similarly, the numbers of participants with HIV laboratory test results were low and largely similar between both groups. Without further statistical analysis or context on the baseline rates and target improvements, definitive conclusions regarding the effectiveness of the WeTest-WeLink mobile health intervention in significantly increasing HIV self-testing or linkage to care cannot be drawn from these raw participant counts alone. The data contributes to understanding participation rates in such interventions.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05484895, titled "Mobile Health Intervention to Increase HIV Testing and Linkage to Care", were posted on 2025-11-05 on clinicaltrials.gov.