N/A
Completed N=50
Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
HIV · Adolescent Behavior
Source: ClinicalTrials.gov NCT04661878 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata — 15; 3 Days
Summary
The overall goal of this pilot randomized-controlled trial (RCT) is to pilot MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app with 50 adolescents and young adults living with HIV to assess its feasibility and acceptability and to explore preliminary effects on ART adherence and social support.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata |
2; 0 | — |
| PRIMARY Intervention Feasibility: Total Time Participants Spend Using the App |
5.67; 0.00 | — |
| PRIMARY Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata |
1 | — |
| PRIMARY Intervention Acceptability: Composite Score From Adapted System Usability Scale |
77.5 | — |
| SECONDARY Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses |
1.00; 2.00 | — |
| SECONDARY Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) |
29.0; 26.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age >= 15 years and <= 21 years
- Knows HIV status (Screened adolescents who do not know their HIV status will receive information on free voluntary HIV counseling and testing services)
- Living with HIV
- Has been prescribed medication to treat HIV
- Not attending school for learners with special needs (e.g., School of Skills)
- Has not repeated a grade in school more than once
- Has a smartphone that can download apps
- Feels comfortable using an app with content in English
- No plan to move outside of Cape Town in the next six months
- Has not previously participated in the MASI app testing phase of our study
- Able to successfully install the MASI app on their smartphone
Exclusion Criteria
- Failure to meet any of the inclusion criteria
- Child dissent despite parent, legal guardian, caregiver informed consent
Data sourced from ClinicalTrials.gov (NCT04661878). 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. Informational only — not medical advice.