Trial Outcomes & Findings for AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification (NCT NCT03090958)

NCT ID: NCT03090958

Last Updated: 2018-07-11

Results Overview

Feasibility of AllyQuest will be based on recruitment success as measured by the total number of individuals who are screened vs. the total number of individuals who are recruited and subsequently enrolled.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-07-11

Participant Flow

Participants were recruited from October, 2016-November, 2016. Participants were recruited from the Cook County Health and Hospitals Systems Infectious Disease Clinic.

21 individuals were contacted to recruit them into the study. 20 participants were consented and enrolled, but 21 individuals were assessed for one of the feasibility measures.

Participant milestones

Participant milestones
Measure
AllyQuest Pilot
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AllyQuest Pilot
n=20 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
Sex: Female, Male
Male
20 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=99 Participants
Race (NIH/OMB)
White
1 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
20 participants
n=99 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 21 individuals were assessed for this outcome measure. The number analyzed were those that were recruited and screened for the study, but not enrolled.

Feasibility of AllyQuest will be based on recruitment success as measured by the total number of individuals who are screened vs. the total number of individuals who are recruited and subsequently enrolled.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=21 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Number of Participants That Were Enrolled of Those Screened
20 Participants

PRIMARY outcome

Timeframe: 4 weeks

Feasibility of AllyQuest will be based retention as measured by the number of missed follow up interviews. Follow up attempts will be documented.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=20 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Number of Participants That Missed Follow up Interviews
17 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Missing data on 3 participants, hence only reporting data on 17 participants.

Feasibility of AllyQuest will be based on usage as measured by the average number days participants access the app.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=17 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Average Number of Days Participants Logged in.
21.2 days
Standard Deviation 14.1

PRIMARY outcome

Timeframe: 4 weeks

Feasibility of AllyQuest will be based on the number of individuals who enroll and do not participate.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=20 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Number of Individuals Who Enroll But do Not Participate
3 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Missing data on 3 participants, hence only reporting data on 17 participants.

Feasibility of AllyQuest will be based on usage as measured by the average time spent using app.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=17 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Average Total Time in Minutes Participants Spent Using App.
158.4 Minutes
Standard Deviation 114.1

PRIMARY outcome

Timeframe: 4 weeks

Population: Missing data on 3 participants, hence only reporting data on 17 participants.

Feasibility of AllyQuest will be based on usage as measured by the average number of activities completed (daily quests), articles read, and social posts made.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=17 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Average Number of App Actions by Participants
Daily Quests
15.8 Activities completed
Standard Deviation 13.5
Average Number of App Actions by Participants
Articles read
8.8 Activities completed
Standard Deviation 7.3
Average Number of App Actions by Participants
Social wall posts
12.9 Activities completed
Standard Deviation 12.5

PRIMARY outcome

Timeframe: 4 weeks

Population: Missing data on 3 participants, hence only reporting data on 17 participants.

Feasibility of AllyQuest will be based on usage as measured by the average number of days participants logged their medications in the app.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=17 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Average Days Participants Logged Medications.
19.4 Days
Standard Deviation 13.2

SECONDARY outcome

Timeframe: 4 weeks

Acceptability of AllyQuest will be measured by the System Usability Scale (SUS). An 11-item, 7-point Likert scale of subjective assessments of usability (1=strongly agree; 7=strongly disagree). The SUS is technology independent and provides a global measure of system satisfaction and sub-scales of usability and learnability.

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=20 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
System Usability Scale Scores
Would use this app frequently
4.41 Scores on a scale
Standard Deviation 1.18
System Usability Scale Scores
App was easy to use
4.76 Scores on a scale
Standard Deviation 0.56
System Usability Scale Scores
Felt very confident using the app
4.47 Scores on a scale
Standard Deviation 1.01
System Usability Scale Scores
App is accurate
4.53 Scores on a scale
Standard Deviation 1.01
System Usability Scale Scores
App is dependable
4.53 Scores on a scale
Standard Deviation 0.62
System Usability Scale Scores
Interaction with app is consistent
4.18 Scores on a scale
Standard Deviation 0.95
System Usability Scale Scores
Found app unnecessarily complex
1.65 Scores on a scale
Standard Deviation 0.86
System Usability Scale Scores
Would need technical assistance to use app
1.71 Scores on a scale
Standard Deviation 1.16
System Usability Scale Scores
App features are well integrated
4.53 Scores on a scale
Standard Deviation 0.80
System Usability Scale Scores
Most people could learn to use app quickly
4.65 Scores on a scale
Standard Deviation 0.61
System Usability Scale Scores
Found app cumbersome to use
2.76 Scores on a scale
Standard Deviation 1.64

SECONDARY outcome

Timeframe: 4 weeks

Acceptability of AllyQuest will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 was used to assess global intervention satisfaction. The CSQ-8 has eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, effectiveness of app for dealing with health problem, overall satisfaction, and willingness to use the app again). These domains are assessed on a 4-point response scale with individually specified anchors. Participant responses are scored from 1 to 4, and thus the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction. The CSQ-8 has demonstrated high internal consistency across a large number of studies and has been used to evaluate technology-based interventions

Outcome measures

Outcome measures
Measure
AllyQuest Pilot
n=20 Participants
The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
Client Satisfaction Questionnaire Score
27.8 Scores on a scale
Standard Deviation 5.9

Adverse Events

AllyQuest Pilot

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

Lisa Hightow Weidman, MD

UNC-Chapel Hill

Phone: 919 966 2536

Results disclosure agreements

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