Trial results for a study investigating an app-based intervention for HIV were posted on ClinicalTrials.gov on 2025-08-19. The study, which enrolled 135 participants, compared an app intervention to no intervention regarding viral suppression and ART adherence.
Background
HIV remains a significant global health challenge, particularly in regions like South Africa. Antiretroviral therapy (ART) has revolutionized HIV management, not only by improving the health of individuals living with HIV but also by nearly eliminating the risk of sexual transmission when viral load is undetectable, a concept known as 'Undetectable = Untransmittable' (U=U) or treatment-as-prevention (TasP). Despite the substantial public health benefits of ART in preventing transmission, awareness of TasP has been found to be low in certain populations. Current public health messaging and clinical HIV counseling in South Africa often do not adequately emphasize the prevention benefits of ART, indicating a need for improved communication strategies to leverage ART's full potential in ending the HIV epidemic.
Trial design
This completed study, designated as Phase NA, enrolled a total of 135 participants living with HIV in South Africa. The trial aimed to integrate the U=U message into HIV counseling. Participants were assigned to one of two arms: Arm A, which received no specific intervention, and Arm B, which utilized the 'Undetectable & You' app.
Key results
The trial reported several key measurements related to HIV care and viral suppression:
- Documented HIV Viral Load <200 Copies/mL at 3-10 Months:
- In Arm A- No Intervention: 22 participants.
- In Arm B- "Undetectable & You" App: 33 participants.
- Started ART Within 30 Days of Baseline:
- In Arm A- No Intervention: 64 participants.
- In Arm B- "Undetectable & You" App: 64 participants.
- ART Refills Beyond 30 Days:
- In Arm A- No Intervention: 55 participants.
- In Arm B- "Undetectable & You" App: 60 participants.
- ART Uptake and First Refill Within 60 Days (Composite Outcome):
- In Arm A- No Intervention: 50 participants.
- In Arm B- "Undetectable & You" App: 53 participants.
- Retained in Care at 1-2 Months:
- In Arm A- No Intervention: 54 participants.
- In Arm B- "Undetectable & You" App: 55 participants.
- Retained in Care at 3-4 Months:
- In Arm A- No Intervention: 48 participants.
- In Arm B- "Undetectable & You" App: 54 participants.
What this means
The results suggest that an intervention like the 'Undetectable & You' app may contribute to improved outcomes for individuals living with HIV. Specifically, a higher number of participants in the app arm achieved viral load suppression compared to the no-intervention arm. While ART initiation within 30 days was similar between groups, the app arm showed slightly higher numbers for ART refills beyond 30 days, composite ART uptake and first refill, and retention in care at 3-4 months. These findings indicate that digital tools could play a role in enhancing adherence and retention in care, ultimately supporting viral suppression and the broader U=U public health message.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04504357, titled 'Integrating U=U Into HIV Counseling in South Africa', were posted on 2025-08-19 on clinicaltrials.gov.