N/A
N=523
Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03803683 ↗Enrolled (actual)
523
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Total Number of Youth Tested for HIV — 154; 123; 68 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mLab App (Device); HIV Prevention Information (Behavioral); HIV Home Tests (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Rebecca Schnall, RN, MPH, PhD
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Youth Tested for HIV |
145; 109; 64 | — |
| PRIMARY Total Number of Youth Tested for HIV |
145; 109; 64 | — |
| SECONDARY Total Number of HIV Negative/ Positive Results |
161; 189; 88; 0; 0; 0 | — |
| SECONDARY Total Number of HIV Negative/ Positive Results |
161; 189; 88; 0; 0; 0 | — |
| SECONDARY Total Number of Youth Who Link to HIV Care Services |
0; 0; 0 | — |
| SECONDARY Total Number of Youth Who Link to HIV Care Services |
0; 0; 0 | — |
| SECONDARY Number of Sexual Partners in the Past 3 Months |
2.24; 2.11; 2.43 | — |
| SECONDARY Number of Sexual Partners in the Past 3 Months |
2.24; 2.11; 2.43 | — |
| SECONDARY Number of Condomless Anal Sex Acts |
7.01; 8.33; 8.32 | — |
| SECONDARY Number of Condomless Anal Sex Acts |
7.01; 8.33; 8.32 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Birth sex male of any current gender identification;
- Understand and read English
- Substantial risk for acquiring HIV infection per CDC guidance (e.g.,YMSM or YTGW and recent anal sex with men)
- Smartphone ownership
- Self-report being HIV-negative or unknown status
- Understand the limitations of the OraQuick test and the mLab App
- Not having been tested for HIV in the past 6 months (e.g., therefore being somewhat outside of the current CDC testing recommendations for high-risk populations)
- Not currently taking PrEP
- Receive a non-reactive result on the rapid HIV test at the Baseline visit
Exclusion Criteria
- Persons who have a known diagnosis of HIV
- Persons for whom the investigators determine that participation may be detrimental to the participant or to the study (e.g., severe cognitive deficit).
Data sourced from ClinicalTrials.gov (NCT03803683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.