Adolescent Behavior, HIV Infections
Conditions
Keywords
mobile health, adolescent, HIV, South Africa, social network, adherence, treatment
Brief 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.
Detailed description
Interventions that engage adolescents and young adults with HIV (AYAHIV) to improve adherence to antiretroviral therapy (ART) are urgently needed. AYAHIV repeatedly demonstrate suboptimal adherence to ART, which is associated with increased morbidity and mortality. Developing adherence-promoting interventions for AYAHIV requires an understanding of factors that shape adherence from multiple levels. Developmental theories suggest that adolescents and young adults are particularly sensitive to their social networks. Mobile health (mHealth) interventions, those that use mobile technology (e.g., smartphones apps) to transmit health information, hold promise as an effective way to improve ART adherence. These smartphone apps can be used to engage social networks and provide social support. Access to mobile phone technology is rapidly increasing among youth in South Africa, making mHealth interventions feasible and potentially scalable in this setting. We developed MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for Let's empower each other and improve our health), an ART adherence-supporting smartphone app for AYAHIV in South Africa. MASI was culturally adapted to the South African context using the evidence based HealthMpowerment platform. HealthMpowerment is a smartphone app-based intervention originally developed by Dr. Lisa Hightow-Weidman, and was developed based on the Institute of Medicine's Integrated Behavior Model with extensive input from youth. The app is designed to foster social support, offer tools for self-monitoring and habit formation, provide resources for goal setting and action planning, and present users with engaging informational resources. This pilot randomized-controlled trial (RCT) is funded through a K01 Mentored Research Scientist Development Award. Prior to the pilot RCT, the study team developed and customized MASI through in-depth interviews and beta-testing with adolescents living with HIV in Cape Town. For the pilot RCT, participants will be randomized to either the full version of the MASI app or an information-only version of MASI control condition (1:1, with stratification by gender). Participants will be asked to engage with MASI for 6 months. All participants will complete baseline and follow-up assessments at 3- and 6-months.
Interventions
BEHAVIORALSocial Support
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
BEHAVIORALInformational Resources
The app will provide opportunities for participants to review HIV-related health information in engaging formats (e.g., activities, multi-media resources, and answer to users' health questions)
BEHAVIORALSelf-Monitoring and habit formation
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
BEHAVIORALGoal setting and action planning
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
Sponsors
University of Cape Town
University of North Carolina
National Institute of Mental Health (NIMH)
Florida State University
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata | Months 1-3 | Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata |
| Intervention Feasibility: Total Time Participants Spend Using the App | Months 1-3 | Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata. |
| Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata | Months 1-3 | Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata. |
| Intervention Acceptability: Composite Score From Adapted System Usability Scale | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses | 3 months | 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? |
| Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) | 3 months | 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). |
Countries
South Africa
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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 | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | MASI | Information-only Version of MASI | Total |
|---|---|---|---|
| Adherence to ART, as measured by 30-day recall of days with missed ART doses | 2 Days with missed ART doses | 3 Days with missed ART doses | 2 Days with missed ART doses |
| Age, Continuous | 18.24 years STANDARD_DEVIATION 1.56 | 19.03 years STANDARD_DEVIATION 1.6 | 18.63 years STANDARD_DEVIATION 1.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Perceived Social Support and Social Isolation | 29.0 units on a scale | 31.0 units on a scale | 29.0 units on a scale |
| 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 | 25 Participants | 25 Participants | 50 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 |
| Self-rating of adherence in the past 30 days Excellent | 6 Participants | 5 Participants | 11 Participants |
| Self-rating of adherence in the past 30 days Fair | 3 Participants | 6 Participants | 9 Participants |
| Self-rating of adherence in the past 30 days Good | 4 Participants | 8 Participants | 12 Participants |
| Self-rating of adherence in the past 30 days Poor | 1 Participants | 0 Participants | 1 Participants |
| Self-rating of adherence in the past 30 days Very good | 10 Participants | 6 Participants | 16 Participants |
| Self-rating of adherence in the past 30 days Very poor | 1 Participants | 0 Participants | 1 Participants |
| Self-reported adherence in the past 30 days (binary) Did not take all pills | 18 Participants | 20 Participants | 38 Participants |
| Self-reported adherence in the past 30 days (binary) Took all pills | 6 Participants | 5 Participants | 11 Participants |
| Self-reported adherence in the past 30 days (binary) Unknown | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
| Sex/Gender, Customized Gender identity Female | 13 Participants | 12 Participants | 25 Participants |
| Sex/Gender, Customized Gender identity Male | 11 Participants | 13 Participants | 24 Participants |
| Sex/Gender, Customized Gender identity Other (participant response = non-binary) | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Intervention Acceptability: Composite Score From Adapted System Usability Scale
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.
Time frame: 6 months
Population: 19 intervention participants completed 6-month survey. Intervention acceptability not applicable for control participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Acceptability: Composite Score From Adapted System Usability Scale | 77.5 score on a scale |
Primary
Intervention Acceptability: Composite Score From Adapted System Usability Scale
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.
Time frame: 3 months
Population: 24 intervention participants completed 3-month survey. Intervention acceptability not applicable for control participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Acceptability: Composite Score From Adapted System Usability Scale | 70.0 score on a scale |
Primary
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Time frame: Months 1-3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata | 15 Days |
| Information-only Version of MASI | Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata | 3 Days |
Primary
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Time frame: Months 4-6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata | 2 Days |
| Information-only Version of MASI | Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata | 0 Days |
Primary
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Time frame: Months 1-3
Population: Feature not available (outcome not measurable) in information-only version of MASI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata | 11 Days |
Primary
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Time frame: Months 4-6
Population: Feature not available (outcome not measurable) in information-only version of MASI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata | 1 Days |
Primary
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Time frame: Months 4-6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Total Time Participants Spend Using the App | 5.67 Minutes |
| Information-only Version of MASI | Intervention Feasibility: Total Time Participants Spend Using the App | 0.00 Minutes |
Primary
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Time frame: Months 1-3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Intervention Feasibility: Total Time Participants Spend Using the App | 58.95 Minutes |
| Information-only Version of MASI | Intervention Feasibility: Total Time Participants Spend Using the App | 11.12 Minutes |
Secondary
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
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?
Time frame: 3 months
Population: 24 intervention participants and 22 control participants completed 3-month survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses | 2.00 Days |
| Information-only Version of MASI | Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses | 2.50 Days |
Secondary
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
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?
Time frame: 6 months
Population: 19 intervention participants and 20 control participants completed 6-month survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses | 1.00 Days |
| Information-only Version of MASI | Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses | 2.00 Days |
Secondary
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
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).
Time frame: 3 months
Population: 24 intervention participants and 22 control participants completed 3-month survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) | 28.0 score on a scale |
| Information-only Version of MASI | Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) | 26.5 score on a scale |
Secondary
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
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).
Time frame: 6 months
Population: 19 intervention participants and 20 control participants completed 6-month survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MASI | Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) | 29.0 score on a scale |
| Information-only Version of MASI | Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS) | 26.5 score on a scale |