HIV/AIDS, Medication Adherence
Conditions
Keywords
adherence, young adult, Africa, mhealth, adolescent, viral load
Brief summary
This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.
Detailed description
Maintaining lifelong adherence to HIV care is a major challenge for older adolescents and young adults (young people) living with HIV in sub-Saharan Africa where HIV infection is globally most prevalent. Innovative, low cost, and easily scaled strategies are urgently needed to improve young people's engagement to HIV treatment and reduce the public health consequences associated with nonadherence including secondary transmission of HIV infection. Modern mobile health (mHealth) interventions improve adherence to care among young people but are currently not feasible for many low-resource areas of sub-Saharan Africa. This includes theory-driven applications that use gamification, where real-life adherence behaviors are combined with interesting story-lines in a mobile game to promote HIV treatment engagement. Whereas web and smartphone access can be limited, traditional cellphones and text messaging are near universal and have been used previously to promote adherence through simple reminders and linkage to staff support in sub-Saharan Africa. However, to date, no text message adherence intervention has been enhanced through the use of gamification. To increase access to this potentially powerful intervention approach, the current study will test a novel mHealth intervention that uses text messages to gamify adherence behavior among YPLH in Ghana. Piloting this intervention will provide information on its feasibility and signs of preliminary efficacy. The ultimate goal following is further evaluation and refinement will be to disseminate the intervention on a large scale across Ghana and other areas of sub-Saharan Africa.
Interventions
BEHAVIORALText-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.
BEHAVIORALStandard 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.
Sponsors
National Institute of Mental Health (NIMH)
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Living with HIV * Reads English and speaks English or a local language (e.g., Twi) * On antiretroviral therapy * Access to mobile phone throughout study period * Able to give consent and not impaired by cognitive or medical limitations as per clinical assessment * Not involved with another HIV prevention or adherence study * Evidence of a detectable viral load
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 Viral Load (log10 Transformed) | Past 90 days | 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. |
| Self-reported Medication Adherence | Past 30 days | 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. |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Text-Based Adherence Game | Standard of Care (SOC) | Total |
|---|---|---|---|
| Age, Continuous | 20.10 years STANDARD_DEVIATION 1.94 | 20.57 years STANDARD_DEVIATION 2.01 | 20.33 years STANDARD_DEVIATION 1.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 30 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Ghana | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
| Visual Analog Scale Past 28-Day Adherence | 6.57 units on a scale STANDARD_DEVIATION 3.65 | 7.90 units on a scale STANDARD_DEVIATION 2.81 | 7.23 units on a scale STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
HIV-1 Viral Load (log10 Transformed)
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.
Time frame: Past 90 days
Population: Analyses were conducted with participants who had viral load data at all three time points (n = 48).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text-Based Adherence Game | HIV-1 Viral Load (log10 Transformed) | 2.22 log10 HIV copies/mL | Standard Deviation 1.44 |
| Standard of Care (SOC) | HIV-1 Viral Load (log10 Transformed) | 2.18 log10 HIV copies/mL | Standard Deviation 1.35 |
p-value: <0.05ANOVA
Primary
Self-reported Medication Adherence
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.
Time frame: Past 30 days
Population: Analyses were conducted with participants who had completed survey assessments at all three time points (n = 51).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text-Based Adherence Game | Self-reported Medication Adherence | 80.73 units on a scale | Standard Deviation 17.32 |
| Standard of Care (SOC) | Self-reported Medication Adherence | 84.03 units on a scale | Standard Deviation 15.49 |
p-value: <0.05ANOVA