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

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ClinicalTrials.gov Identifier: NCT03090958
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : June 8, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ young men who have sex with men (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. AllyQuest will be an interactive mobile phone intervention for HIV+ YMSM that utilizes social networking, game-based mechanics and a story-based framework to guide behavior change. Grounded in Social Cognitive Theory, narrative communication and the principles of persuasive technology, the intervention is designed to capitalize on social involvement as a means through which HIV+ YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers.

Condition or disease Intervention/treatment Phase
Hiv HIV/AIDS Behavioral: AllyQuest Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: In order to assess the feasibility and acceptability of the app. 20 participants will be enrolled in a one month pilot trial. After being screened for eligibility, 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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 development of this intervention is both timely and vital given the urgency of the ongoing HIV epidemic among 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.




Primary Outcome Measures :
  1. Number of Participants That Were Enrolled of Those Screened [ Time Frame: 4 weeks ]
    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.

  2. Number of Participants That Missed Follow up Interviews [ Time Frame: 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.

  3. Average Number of Days Participants Logged in. [ Time Frame: 4 weeks ]
    Feasibility of AllyQuest will be based on usage as measured by the average number days participants access the app.

  4. Number of Individuals Who Enroll But do Not Participate [ Time Frame: 4 weeks ]
    Feasibility of AllyQuest will be based on the number of individuals who enroll and do not participate.

  5. Average Total Time in Minutes Participants Spent Using App. [ Time Frame: 4 weeks ]
    Feasibility of AllyQuest will be based on usage as measured by the average time spent using app.

  6. Average Number of App Actions by Participants [ Time Frame: 4 weeks ]
    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.

  7. Average Days Participants Logged Medications. [ Time Frame: 4 weeks ]
    Feasibility of AllyQuest will be based on usage as measured by the average number of days participants logged their medications in the app.


Secondary Outcome Measures :
  1. System Usability Scale Scores [ Time Frame: 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.

  2. Client Satisfaction Questionnaire Score [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   assigned male at birth and self identify as male.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive
  • Diagnosed in the last 12 months
  • Assigned male at birth and self identify as male
  • Have had sex with another man in the last twelve months
  • Own a smart phone
  • Between the ages of 16-24

Exclusion Criteria:

  • Assigned female at birth
  • Non-English speaker
  • HIV negative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090958


Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lisa Hightow-Weidman, MD, MPH UNC-CH

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03090958     History of Changes
Other Study ID Numbers: 15-0948
5R21MH107266-02 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: July 11, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
technology
app
YMSM
HIV