Piloting a Smartphone App to Improve Treatment Adherence... | NCT04661878

ID	Type	Description	Link
K01MH118072	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
University of Cape Town	OTHER
University of North Carolina	OTHER
National Institute of Mental Health (NIMH)	NIH
Florida State University

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Behavioral: Informational Resources

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Social Support	Behavioral	The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	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.	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.	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.	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.	Months 4-6

Secondary Outcomes

Measure	Description	Time Frame
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? "	3 months

Eligibility Module

Name	Affiliation	Role
Marta I Mulawa, PhD	Duke University	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37725409	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 30, 2024

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00025 BG00125 BG00250

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00015(5 to 22) OG0013(2 to 9)

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

Posted

Median

Inter-Quartile Range

Days

Months 4-6

ID	Title	Description
OG000	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.
OG001	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

Units	Counts
Participants

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.

Posted

Median

Inter-Quartile Range

Minutes

Months 1-3

ID	Title	Description
OG000	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.
OG001	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

Units	Counts
Participants

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.

Posted

Median

Inter-Quartile Range

Minutes

Months 4-6

ID	Title	Description
OG000	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.
OG001	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

Units	Counts
Participants

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.

Feature not available (outcome not measurable) in information-only version of MASI

Posted

Median

Inter-Quartile Range

Days

Months 1-3

ID	Title	Description
OG000	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.
OG001	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

Units	Counts

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.

Feature not available (outcome not measurable) in information-only version of MASI

Posted

Median

Inter-Quartile Range

Days

Months 4-6

ID	Title	Description
OG000	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.
OG001	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

Units	Counts

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.

24 intervention participants completed 3-month survey. Intervention acceptability not applicable for control participants.

Posted

Median

Inter-Quartile Range

score on a scale

3 months

ID	Title	Description
OG000	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.
OG001	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

Primary

Intervention Acceptability: Composite Score From Adapted System Usability Scale

19 intervention participants completed 6-month survey. Intervention acceptability not applicable for control participants.

Posted

Median

Inter-Quartile Range

score on a scale

6 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses

24 intervention participants and 22 control participants completed 3-month survey

Posted

Median

Inter-Quartile Range

Days

3 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses

19 intervention participants and 20 control participants completed 6-month survey

Posted

Median

Inter-Quartile Range

Days

6 months

ID	Title	Description
OG000	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.
OG001	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

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).

24 intervention participants and 22 control participants completed 3-month survey

Posted

Median

Inter-Quartile Range

score on a scale

3 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)

19 intervention participants and 20 control participants completed 6-month survey

Posted

Median

Inter-Quartile Range

score on a scale

6 months

ID	Title	Description
OG000	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.
OG001	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

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	25	0	25	0	25
EG001	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	0	25	0	25	0	25

ID	Term
D015658	HIV Infections
D000294	Adolescent Behavior

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D001519	Behavior