mLab App RCT
About Study
We conducted a study to assess HIV testing and linkage to care among young adults. This study is for young adults who are HIV negative. As such, participants conduct an at-home HIV test using the OraQuick rapid HIV test.
If participants test HIV negative and are enrolled in the study, the following happens:
- Participants receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, Pre-Exposure Prophylaxis (PrEP) assessment, and referral information for clinics that provide PrEP during the first visit.
- Participants complete a video-conference call with a member of the study team to complete an online survey for the first visit, which takes about 1-2 hours.
- Six months after the initial appointment, participants complete another survey remotely via Zoom. A similar follow up survey is also completed at 12 months.
For Researchers
The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.
This FDA reviewed RCT has concluded, as of October 2023. Data analysis is ongoing. Please review preliminary results.
Please review ClinicalTrials.gov information.