Trial Outcomes & Findings for Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV (NCT NCT04661878)
NCT ID: NCT04661878
Last Updated: 2025-06-13
Results Overview
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Months 1-3
Results posted on
2025-06-13
Participant Flow
Participants were recruited at antiretroviral therapy (ART) clinics in Cape Town, South Africa. Potential participants were identified from participant lists in other research studies who gave consent to be contacted for future research. Additional participants were recruited from public ART clinics linked to the tertiary teaching hospital, where all in-person study visits were conducted.
Participant milestones
| Measure |
MASI
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
MASI
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
Baseline Characteristics
1 MASI participant response "unknown"
Baseline characteristics by cohort
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=25 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.24 years
STANDARD_DEVIATION 1.56 • n=25 Participants
|
19.03 years
STANDARD_DEVIATION 1.60 • n=25 Participants
|
18.63 years
STANDARD_DEVIATION 1.61 • n=50 Participants
|
|
Sex/Gender, Customized
Gender identity · Female
|
13 Participants
n=25 Participants
|
12 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Gender identity · Male
|
11 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
24 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Gender identity · Other (participant response = non-binary)
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=25 Participants
|
12 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Adherence to ART, as measured by 30-day recall of days with missed ART doses
|
2 Days with missed ART doses
n=24 Participants • 1 MASI participant response "unknown"
|
3 Days with missed ART doses
n=25 Participants • 1 MASI participant response "unknown"
|
2 Days with missed ART doses
n=49 Participants • 1 MASI participant response "unknown"
|
|
Self-reported adherence in the past 30 days (binary)
Did not take all pills
|
18 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
38 Participants
n=50 Participants
|
|
Self-reported adherence in the past 30 days (binary)
Took all pills
|
6 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
11 Participants
n=50 Participants
|
|
Self-reported adherence in the past 30 days (binary)
Unknown
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Very poor
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Poor
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Fair
|
3 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
9 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Good
|
4 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
12 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Very good
|
10 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
16 Participants
n=50 Participants
|
|
Self-rating of adherence in the past 30 days
Excellent
|
6 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
11 Participants
n=50 Participants
|
|
Perceived Social Support and Social Isolation
|
29.0 units on a scale
n=25 Participants
|
31.0 units on a scale
n=25 Participants
|
29.0 units on a scale
n=50 Participants
|
PRIMARY outcome
Timeframe: Months 1-3Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=25 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
|
15 Days
Interval 5.0 to 22.0
|
3 Days
Interval 2.0 to 9.0
|
PRIMARY outcome
Timeframe: Months 4-6Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=25 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
|
2 Days
Interval 0.0 to 10.0
|
0 Days
Interval 0.0 to 4.0
|
PRIMARY outcome
Timeframe: Months 1-3Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=25 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Total Time Participants Spend Using the App
|
58.95 Minutes
Interval 6.69 to 105.69
|
11.12 Minutes
Interval 3.58 to 35.53
|
PRIMARY outcome
Timeframe: Months 4-6Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=25 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Total Time Participants Spend Using the App
|
5.67 Minutes
Interval 0.0 to 38.89
|
0.00 Minutes
Interval 0.0 to 6.89
|
PRIMARY outcome
Timeframe: Months 1-3Population: Feature not available (outcome not measurable) in information-only version of MASI
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
|
11 Days
Interval 1.0 to 25.0
|
—
|
PRIMARY outcome
Timeframe: Months 4-6Population: Feature not available (outcome not measurable) in information-only version of MASI
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Outcome measures
| Measure |
MASI
n=25 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
|
1 Days
Interval 0.0 to 5.0
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 24 intervention participants completed 3-month survey. Intervention acceptability not applicable for control participants.
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.
Outcome measures
| Measure |
MASI
n=24 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Acceptability: Composite Score From Adapted System Usability Scale
|
70.0 score on a scale
Interval 65.0 to 75.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 19 intervention participants completed 6-month survey. Intervention acceptability not applicable for control participants.
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.
Outcome measures
| Measure |
MASI
n=19 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Intervention Acceptability: Composite Score From Adapted System Usability Scale
|
77.5 score on a scale
Interval 70.0 to 80.0
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 24 intervention participants and 22 control participants completed 3-month survey
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? "
Outcome measures
| Measure |
MASI
n=24 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=22 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
|
2.00 Days
Interval 0.0 to 3.0
|
2.50 Days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 19 intervention participants and 20 control participants completed 6-month survey
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? "
Outcome measures
| Measure |
MASI
n=19 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=20 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
|
1.00 Days
Interval 0.0 to 3.0
|
2.00 Days
Interval 0.75 to 4.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 24 intervention participants and 22 control participants completed 3-month survey
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).
Outcome measures
| Measure |
MASI
n=24 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=22 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
|
28.0 score on a scale
Interval 25.8 to 33.3
|
26.5 score on a scale
Interval 24.3 to 31.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 19 intervention participants and 20 control participants completed 6-month survey
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).
Outcome measures
| Measure |
MASI
n=19 Participants
Participants randomized to the intervention condition received access to the full MASI app, including all its six features (i.e., Health Tracker, Forum, Ask the Expert, Activities, and Resources), and virtual access to MASI Peer Mentor support via the app. MASI is a comprehensive digital app intervention designed to promote ART adherence and foster social support using a strengths-based approach. MASI was adapted to the cultural context of South African adolescents and young adults living with HIV.
|
Information-only Version of MASI
n=20 Participants
Participants randomized to the control condition received access to an information-only control app (consisting of only the Resource feature) delivered through MASI platform
|
|---|---|---|
|
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
|
29.0 score on a scale
Interval 26.5 to 31.5
|
26.5 score on a scale
Interval 24.0 to 29.0
|
Adverse Events
MASI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information-only Version of MASI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place