HIV InfectionsNCT04661878
Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
A study testing Social Support, Informational Resources and Self-Monitoring and habit formation in people with HIV Infections and Adolescent Behavior, run by Duke University at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- HIV Infections, Adolescent Behavior
- What is being tested?
- Social Support, Informational Resources and Self-Monitoring and habit formation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Jun 2022to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Failure to meet any of the inclusion criteria
- Child dissent despite parent, legal guardian, caregiver informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Adolescent Behavior
- Being tested
- Social Support, Informational Resources, Self-Monitoring and habit formation, Goal setting and action planning
- Keywords
- mobile health, adolescent, HIV, South Africa, social network, adherence, treatment
- Medical subject headings
- HIV Infections, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social SupportBehavioural
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
Informational ResourcesBehavioural
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)
Self-Monitoring and habit formationBehavioural
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
Goal setting and action planningBehavioural
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
| Study group | Role | What they receive |
|---|---|---|
| MASI | Experimental | Participants randomized to the intervention condition will receive access to MASI, the smartphone app customized for this study. MASI is an adapted version of HealthMpowerment, a theory-based smartphone app with features including an anonymous interactive discussion forum, a medication and adherence tracker, a platform to ask questions to an expert, a section with engaging activities (including quizzes, self-assessments, and goal-setting activities), and a multi-media resource center. Receives: Behavioral: Social Support; Behavioral: Informational Resources; Behavioral: Self-Monitoring and habit formation; Behavioral: Goal setting and action planning |
| Information-only version of MASI | Active comparator | Participants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page. Receives: Behavioral: Informational Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Months 1-3
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
Measured: Months 4-6
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.
Measured: Months 1-3
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.
Measured: Months 4-6
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.
Measured: Months 1-3
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.
Measured: Months 4-6
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.
Measured: 3 months
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.
Measured: 6 months
Secondary outcomes (4)
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? "
Measured: 3 months
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? "
Measured: 6 months
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).
Measured: 3 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start21 Jun 2022
- Primary completion15 Mar 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, University of North Carolina, National Institute of Mental Health (NIMH), Florida State University
- Responsible party
- Sponsor
- Investigators
- Marta I Mulawa, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661878
- Sponsor's protocol ID
- Pro00103309
- Other IDs
- K01MH118072
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2020
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from this pilot randomized controlled trial will be shared after the publication of the main trial findings within the constraints required for the protection of confidentiality for study subjects. De-identified data will be available through individual requests directed to the Principal Investigator.
Publications
Mulawa MI, Hoare J, Knippler ET, Mtukushe B, Matiwane M, Muessig KE, Al-Mujtaba M, Wilkinson TH, Platt A, Egger JR, Hightow-Weidman LB. MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 19;12:e47137. doi: 10.2196/47137.
PubMed 37725409
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
- ClinicalTrials.gov ID
- NCT04661878
- Acronym / sponsor ID
- Pro00103309
- Conditions
- HIV Infections, Adolescent Behavior
- Keywords
- mobile health, adolescent, HIV, South Africa, social network, adherence, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town, University of North Carolina, National Institute of Mental Health (NIMH), Florida State University
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASI | Experimental | Behavioral: Social Support, Behavioral: Informational Resources, Behavioral: Self-Monitoring and habit formation, Behavioral: Goal setting and action planningParticipants randomized to the intervention condition will receive access to MASI, the smartphone app customized for this study. MASI is an adapted version of HealthMpowerment, a theory-based smartphone app with features including an anonymous interactive discussion forum, a medication and adherence tracker, a platform to ask questions to an expert, a section with engaging activities (including quizzes, self-assessments, and goal-setting activities), and a multi-media resource center. |
| Information-only version of MASI | Active comparator | Behavioral: Informational ResourcesParticipants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (2 listed)
- Failure to meet any of the inclusion criteria
- Child dissent despite parent, legal guardian, caregiver informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social SupportThe app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support. | Behavioural | MASI |
| Informational ResourcesThe 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) | Behavioural | Information-only version of MASI, MASI |
| Self-Monitoring and habit formationThe app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders. | Behavioural | MASI |
| Goal setting and action planningThe app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan. | Behavioural | MASI |
Primary outcome
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Time frame: 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: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Time frame: Months 4-6
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
Time frame: 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: Total Time Participants Spend Using the App
Time frame: Months 4-6
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
Time frame: 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 Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Time frame: Months 4-6
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
Time frame: 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.
Intervention Acceptability: Composite Score From Adapted System Usability Scale
Time frame: 6 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.
4 secondary outcomes
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
Time frame: 3 months
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
Time frame: 6 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
Time frame: 3 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37725409Mulawa MI, Hoare J, Knippler ET, Mtukushe B, Matiwane M, Muessig KE, Al-Mujtaba M, Wilkinson TH, Platt A, Egger JR, Hightow-Weidman LB. MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 19;12:e47137. doi: 10.2196/47137.
- Individual participant dataSharing planned: No. The data from this pilot randomized controlled trial will be shared after the publication of the main trial findings within the constraints required for the protection of confidentiality for study subjects. De-identified data will be available through individual requests directed to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta I Mulawa, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Support, Informational Resources and Self-Monitoring and habit formation in people with HIV Infections and Adolescent Behavior, run by Duke University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata (time frame: Months 1-3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.