Trial Outcomes & Findings for PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS (NCT NCT03758066)

NCT ID: NCT03758066

Last Updated: 2023-10-26

Results Overview

Comparison of average CD4 cell count (cells/mm\^3) between pre and post time points

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 1 year prior to baseline (pre), 1 year post-baseline (post)
• Results posted on: 2023-10-26

Participant Flow

Study participants were recruited and enrolled into the study between January 2019 to June 2019 from 3 HIV/AIDS programs at two large, private, not-for-profit academic hospitals in the metro Boston area. Participants were case management program team members (CMs) and adolescents and young adults (AYA) living with HIV. CMs were enrolled and trained on the system first. Patients were then enrolled on a rolling basis. An RA at each site assessed eligibility, consented and enrolled participants.

There were no significant effects that occurred after participant enrollment that affected enrolled participants receiving the intervention. This was a one-armed prospective study where participants were enrolled into the study and then enrolled into the PlusCare system in-person in one session.

Participant milestones

Measure	PlusCare AYA living with HIV and CMs who work with them will be given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year. PlusCare is a web/mobile application designed to be used by youth and young adults with HIV and case managers.
Overall Study STARTED	65
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	PlusCare AYA living with HIV and CMs who work with them will be given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year. PlusCare is a web/mobile application designed to be used by youth and young adults with HIV and case managers.
Overall Study Lost to Follow-up	14

Baseline Characteristics

Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)

Baseline characteristics by cohort

Measure	PlusCare n=65 Participants Patients and case managers who work with them will be given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year. PlusCare: PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
Age, Categorical AYA living with HIV · <=18 years	12 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Age, Categorical AYA living with HIV · Between 18 and 65 years	33 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Age, Categorical AYA living with HIV · >=65 years	0 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Age, Categorical CM · <=18 years	0 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Age, Categorical CM · Between 18 and 65 years	20 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Age, Categorical CM · >=65 years	0 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Sex: Female, Male AYA living with HIV · Female	23 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Sex: Female, Male AYA living with HIV · Male	22 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Sex: Female, Male CM · Female	18 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Sex: Female, Male CM · Male	2 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized AYA living with HIV · Hispanic/Latino	8 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized AYA living with HIV · Not Hispanic, White	4 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized AYA living with HIV · Not Hispanic, Black	24 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized AYA living with HIV · Not Hispanic, Other (incl. Native American, Asian/Pacific Islander, More than one)	6 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized AYA living with HIV · Unknown ethnicity	3 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized CM · Hispanic/Latino	1 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized CM · Not Hispanic, White	12 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized CM · Not Hispanic, Black	4 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized CM · Not Hispanic, Other (incl. Native American, Asian/Pacific Islander, More than one)	1 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Race/Ethnicity, Customized CM · Unknown ethnicity	2 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · High school graduate or less	24 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · Some college credit or more	20 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · Bachelor's Degree	0 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · Master's Degree	0 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · Doctoral Degree	0 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education AYA living with HIV · Professional Degree	0 Participants n=44 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · High school graduate or less	0 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · Some college credit or more	0 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · Bachelor's Degree	7 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · Master's Degree	7 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · Doctoral Degree	4 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Education CM · Professional Degree	2 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Smartphone ownership AYA living with HIV · iPhone	40 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Smartphone ownership AYA living with HIV · Android	5 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Smartphone ownership CM · iPhone	17 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Smartphone ownership CM · Android	3 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day AYA living with HIV · 0-3 hours	8 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day AYA living with HIV · 4-6 hours	19 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day AYA living with HIV · 7+ hours	18 Participants n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day CM · 0-3 hours	9 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day CM · 4-6 hours	8 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Hours on the phone per day CM · 7+ hours	3 Participants n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Tech savvy AYA living with HIV	7.86 units on a scale STANDARD_DEVIATION 1.58 • n=45 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)
Tech savvy CM	7.05 units on a scale STANDARD_DEVIATION 1.23 • n=20 Participants • Demographics are reported for each of the 2 participant types (CM and AYA living with HIV)

PRIMARY outcome

Timeframe: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of average CD4 cell count (cells/mm^3) between pre and post time points

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
CD4 Cell Count Pre	996 cells/mm^3 Interval 857.0 to 1157.0
CD4 Cell Count Post	1049 cells/mm^3 Interval 898.0 to 1224.0

PRIMARY outcome

Timeframe: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of average viral load (copies/mL) between pre and post time points

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
Viral Load Pre	32.0 copies/mL Interval 17.9 to 60.4
Viral Load Post	24.7 copies/mL Interval 12.1 to 47.9

PRIMARY outcome

Timeframe: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of median appointment adherence ratio between pre and post time points, i.e., (Actual completed appointments) / (Expected appointments) where expected appointments includes completed appointments, no shows, and cancellations

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
Appointment Adherence Rate Pre	0.60 appointment adherence ratio Standard Deviation .19
Appointment Adherence Rate Post	.67 appointment adherence ratio Standard Deviation .25

SECONDARY outcome

Timeframe: Monthly

Self-reported levels of medication adherence were reported on a monthly basis, where AYA living with HIV rated their adherence to their prescribed medication using the self-rating scale item (SRSI) single-item adherence measure. Patients reported medication adherence for the past month on a 6-point Likert scale ranging from 1 ("very poor") to 6 ("excellent"). Patients received monthly SMS text messages alerting them to report adherence via survey forms created in the PlusCare app. Mean self-reported monthly medication adherence ratings across 12 months is reported.

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
Proximal Outcomes (Monthly Medication Adherence Item)	4.7 score on a scale Standard Deviation .23

SECONDARY outcome

Timeframe: 1 year (Baseline, 6-month, 12-month)

Population: Participants who completed the quality of life general health assessment (CDC HRQOL-4) at baseline, 6 months, and 12 months (end of study).

Self-reported scores to the General Health item of the CDC "Health Days Measure" Core Module (CDC HRQOL-4) item were compared between 3 timepoints, with scores ranging from 1 ("Poor") to 5 ("Excellent").

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey Baseline	3.6 score on a scale Standard Deviation .12
Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey 6-month	3.6 score on a scale Standard Deviation .16
Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey 12-month	3.9 score on a scale Standard Deviation .16

SECONDARY outcome

Timeframe: 1 year (Baseline, 6-month, 12-month)

Population: Participants who completed self-efficacy assessment (SEMCD6) at baseline, 6 months, and 12 months (end of study).

Self-reported average scores to the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD6) were compared between 3 timepoints. SEMCD6 scores range from 1 to 10, with higher numbers indicating higher self-efficacy.

Outcome measures

Measure	PlusCare n=45 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey Baseline	7.8 score on a scale Standard Deviation .3
Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey 6-month	7.8 score on a scale Standard Deviation .36
Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey 12-month	8.6 score on a scale Standard Deviation .27

SECONDARY outcome

Timeframe: 1 year

Population: Summary of SUS scores reported for 13 (out of 20) CMs and 38 (out of 45) AYA living with HIV participants who completed the survey.

Self-reported ratings of perceived system usability on the 10-point Likert-scaled System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability, were collected at end of study.

Outcome measures

Measure	PlusCare n=51 Participants AYA living with HIC given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year
System Usability (User Satisfaction): System Usability Scale AYA living with HIV	63 score on a scale Standard Deviation 10.6
System Usability (User Satisfaction): System Usability Scale CM	51 score on a scale Standard Deviation 7.9

Adverse Events

PlusCare

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

Y. Xian Ho

Dimagi, Inc.

Phone: 617-649-2214

Email: yho@dimagi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place