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Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
NA trial testing Social Support in HIV Infections in 50 participants. Completed in 2 April 2024.
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 21 June 2022 |
| Primary completion | 15 March 2024 |
| Estimated completion | 2 April 2024 |
| Sites | 1 location across South Africa |
Duke University
Adults 15 to 21, any sex, with HIV Infections or Adolescent Behavior. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
| Group | Value | 95% CI |
|---|---|---|
| MASI | 15 | 5 – 22 |
| Information-only Version of MASI | 3 | 2 – 9 |
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
| Group | Value | 95% CI |
|---|---|---|
| MASI | 2 | 0 – 10 |
| Information-only Version of MASI | 0 | 0 – 4 |
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 58.95 | 6.69 – 105.69 |
| Information-only Version of MASI | 11.12 | 3.58 – 35.53 |
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 5.67 | 0.00 – 38.89 |
| Information-only Version of MASI | 0.00 | 0.00 – 6.89 |
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 11 | 1 – 25 |
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 1 | 0 – 5 |
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 70.0 | 65.0 – 75.0 |
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
| Group | Value | 95% CI |
|---|---|---|
| MASI | 77.5 | 70.0 – 80.0 |
Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "
| Group | Value | 95% CI |
|---|---|---|
| MASI | 2.00 | 0.00 – 3.00 |
| Information-only Version of MASI | 2.50 | 1.00 – 3.00 |
Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "
| Group | Value | 95% CI |
|---|---|---|
| MASI | 1.00 | 0.00 – 3.00 |
| Information-only Version of MASI | 2.00 | 0.75 – 4.00 |
Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).
| Group | Value | 95% CI |
|---|---|---|
| MASI | 28.0 | 25.8 – 33.3 |
| Information-only Version of MASI | 26.5 | 24.3 – 31.0 |
Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).
| Group | Value | 95% CI |
|---|---|---|
| MASI | 29.0 | 26.5 – 31.5 |
| Information-only Version of MASI | 26.5 | 24.0 – 29.0 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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