Trial results for a pilot study of the MASI smartphone app, aimed at improving treatment adherence among South African adolescents living with HIV, were posted on ClinicalTrials.gov on 2025-06-13. The study enrolled 50 participants.
Background
Adherence to antiretroviral therapy (ART) is crucial for managing HIV infections, particularly among adolescents. This demographic often faces unique challenges that can impact consistent medication intake, including social stigma, developmental factors, and access to support. Smartphone applications offer a promising avenue to provide discreet, accessible support and reminders, potentially improving treatment adherence and overall health outcomes. The MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health") app was developed to address these needs by providing adherence support and fostering social support among adolescents and young adults living with HIV.
Trial design
This completed pilot randomized-controlled trial, designated as Phase NA, enrolled 50 adolescents and young adults. The study investigated conditions including HIV Infections and Adolescent Behavior. The trial aimed to assess the feasibility and acceptability of the MASI smartphone app and to explore its preliminary effects on ART adherence and social support. Participants were randomized to either the MASI app or an information-only version of MASI.
Key results
The trial reported several key measurements related to intervention feasibility and acceptability:
- Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata:
- For the MASI group, a median of 15 days was observed.
- For the Information-only Version of MASI group, a median of 3 days was observed.
- In another measurement for the MASI group, a median of 2 days was observed.
- For the Information-only Version of MASI group, a median of 0 days was observed.
- Intervention Feasibility: Total Time Participants Spend Using the App:
- For the MASI group, a median of 58.95 minutes was observed.
- For the Information-only Version of MASI group, a median of 11.12 minutes was observed.
- In another measurement for the MASI group, a median of 5.67 minutes was observed.
- For the Information-only Version of MASI group, a median of 0.00 minutes was observed.
- Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata:
- For the MASI group, a median of 11 days was observed.
- In another measurement for the MASI group, a median of 1 day was observed.
- Intervention Acceptability: Composite Score From Adapted System Usability Scale:
- For the MASI group, a median score of 70.0 was observed.
- In another measurement for the MASI group, a median score of 77.5 was observed.
What this means
The pilot results suggest that the MASI smartphone app demonstrates promising feasibility and acceptability among South African adolescents living with HIV. The MASI app showed substantially higher engagement in terms of median login days and total usage time compared to the information-only version, indicating that its interactive features may encourage greater participant interaction. The reported usability scores further support the app's acceptability. These findings provide initial evidence for the potential of tailored digital interventions to support ART adherence in this vulnerable population, laying groundwork for larger-scale trials to confirm efficacy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04661878, titled "Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV", were posted on 2025-06-13 on clinicaltrials.gov.