Trial Outcomes & Findings for A Text-Based Adherence Game for Young People Living With HIV in Ghana (NCT NCT03928717)
NCT ID: NCT03928717
Last Updated: 2024-06-04
Results Overview
This is a measure of the number of copies of HIV in a person's blood (i.e., copies per ml). It was assessed through blood draw and lab testing. For analyses, raw viral load was log10 transformed to reduce skewness.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Past 90 days
Results posted on
2024-06-04
Participant Flow
Participant milestones
| Measure |
Text-Based Adherence Game
Participants in the experimental condition will receive the Text Based Adherence Game. They will receive semi-automated text messages sent by study staff throughout the trial period.
Text-Based Adherence Game: A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
Standard of Care (SOC)
SOC participants will receive the Standard of Care Intervention which includes receiving a brief adherence counseling session and access to clinic resources, including counseling services, throughout the trial period.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Text-Based Adherence Game for Young People Living With HIV in Ghana
Baseline characteristics by cohort
| Measure |
Text-Based Adherence Game
n=30 Participants
Participants in the experimental condition will receive the Text Based Adherence Game. They will receive semi-automated text messages sent by study staff throughout the trial period.
Text-Based Adherence Game: A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
Standard of Care (SOC)
n=30 Participants
SOC participants will receive the Standard of Care Intervention which includes receiving a brief adherence counseling session and access to clinic resources, including counseling services, throughout the trial period.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.10 years
STANDARD_DEVIATION 1.94 • n=99 Participants
|
20.57 years
STANDARD_DEVIATION 2.01 • n=107 Participants
|
20.33 years
STANDARD_DEVIATION 1.97 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Ghana
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Visual Analog Scale Past 28-Day Adherence
|
6.57 units on a scale
STANDARD_DEVIATION 3.65 • n=99 Participants
|
7.90 units on a scale
STANDARD_DEVIATION 2.81 • n=107 Participants
|
7.23 units on a scale
STANDARD_DEVIATION 3.30 • n=206 Participants
|
PRIMARY outcome
Timeframe: Past 90 daysPopulation: Analyses were conducted with participants who had viral load data at all three time points (n = 48).
This is a measure of the number of copies of HIV in a person's blood (i.e., copies per ml). It was assessed through blood draw and lab testing. For analyses, raw viral load was log10 transformed to reduce skewness.
Outcome measures
| Measure |
Text-Based Adherence Game
n=23 Participants
Participants in the experimental condition will receive the Text Based Adherence Game. They will receive semi-automated text messages sent by study staff throughout the trial period.
Text-Based Adherence Game: A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
Standard of Care (SOC)
n=25 Participants
SOC participants will receive the Standard of Care Intervention which includes receiving a brief adherence counseling session and access to clinic resources, including counseling services, throughout the trial period.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
|---|---|---|
|
HIV-1 Viral Load (log10 Transformed)
|
2.22 log10 HIV copies/mL
Standard Deviation 1.44
|
2.18 log10 HIV copies/mL
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Past 30 daysPopulation: Analyses were conducted with participants who had completed survey assessments at all three time points (n = 51).
The 3-item Self-Report Medication Adherence Scale is used to measure self-reported antiretroviral adherence in the past 30 days. Responses to each of the three items are linearly transformed to a 0-100 scale with zero being the worst adherence and 100 the best. A total score is calculated as the mean of the three individual item scores and ranges from 0 to 100.
Outcome measures
| Measure |
Text-Based Adherence Game
n=25 Participants
Participants in the experimental condition will receive the Text Based Adherence Game. They will receive semi-automated text messages sent by study staff throughout the trial period.
Text-Based Adherence Game: A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
Standard of Care (SOC)
n=26 Participants
SOC participants will receive the Standard of Care Intervention which includes receiving a brief adherence counseling session and access to clinic resources, including counseling services, throughout the trial period.
Standard of Care (SOC): A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
|
|---|---|---|
|
Self-reported Medication Adherence
|
80.73 units on a scale
Standard Deviation 17.32
|
84.03 units on a scale
Standard Deviation 15.49
|
Adverse Events
Text-Based Adherence Game
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care (SOC)
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