Trial results for a study investigating mobile-enhanced prevention support for HIV were posted on ClinicalTrials.gov on 2026-02-02, with 233 participants enrolled.
Background
HIV prevention remains a critical public health challenge, particularly among vulnerable populations such as men who have sex with men and transgender women with substance use disorders transitioning from jail. These individuals often face significant barriers to accessing healthcare and HIV prevention services, including pre-exposure prophylaxis (PrEP). Effective interventions are needed to bridge this gap, ensuring continuity of care and support for PrEP uptake and adherence to reduce HIV transmission rates in the community.
Trial design
This completed study, designated as Phase NA, enrolled 233 participants to investigate conditions including HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, and Substance Use Disorders. The trial compared routine case management provided following enrollment to an intervention group with access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support. The study aimed to assess the utilization of HIV prevention and other support services.
Key results
The trial reported several key measurements related to HIV prevention service utilization:
- For establishing a primary care provider who can prescribe PrEP:
- 82 participants in the Standard of Care group.
- 90 participants in the Mobile Enhanced Prevention Support group.
- For initiating a PrEP regimen:
- 12 participants in the Standard of Care group.
- 28 participants in the Mobile Enhanced Prevention Support group.
- For demonstrating minimal adherence to PrEP:
- 10 participants in the Standard of Care group.
- 26 participants in the Mobile Enhanced Prevention Support group.
- For remaining on PrEP for at least 3 months:
- 7 participants in the Standard of Care group.
- 17 participants in the Mobile Enhanced Prevention Support group.
- For reporting an HIV test within 3 months of a follow-up (first measurement):
- 44 participants in the Standard of Care group.
- 55 participants in the Mobile Enhanced Prevention Support group.
- For reporting an HIV test within 3 months of a follow-up (second measurement):
- 32 participants in the Standard of Care group.
- 50 participants in the Mobile Enhanced Prevention Support group.
Key analyses indicated significant differences in some outcomes:
- A longitudinal trajectory model reported an Odds Ratio (OR) of 3.8 (95.0% CI: 1.8, 8.0) with a p-value of 0.0006.
- A Mixed Models Analysis reported a p-value of 0.0158.
- Other analyses included a Poisson regression with a Risk Ratio (RR) of 1.07 (95.0% CI: 0.66, 1.74) and a p-value of 0.78, and Chi-squared tests with p-values of 0.1191 and 0.9689. Another Mixed Models Analysis reported a p-value of 0.1683.
What this means
The results suggest that mobile-enhanced prevention support, including a GPS-based app, incentives, and peer mentorship, can significantly improve engagement in HIV prevention services. Notably, the intervention group showed higher numbers of participants initiating and adhering to PrEP, as well as remaining on PrEP for at least 3 months. The significant odds ratio and p-values from certain analyses indicate a positive impact of the mobile-enhanced approach on key outcomes related to HIV prevention, offering a promising strategy for vulnerable populations transitioning from incarceration.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04036396, titled "Mobile Enhanced Prevention Support for People Leaving Jail", were posted on 2026-02-02 on clinicaltrials.gov.