NCT03090958

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2018

Completed
Last Updated

July 11, 2018

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

March 13, 2017

Results QC Date

January 22, 2018

Last Update Submit

June 12, 2018

Conditions

Keywords

technologyappYMSMHIV

Outcome Measures

Primary Outcomes (7)

  • Number of Participants That Were Enrolled of Those Screened

    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.

    4 weeks

  • Number of Participants That Missed Follow up Interviews

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

    4 weeks

  • Average Number of Days Participants Logged in.

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

    4 weeks

  • Number of Individuals Who Enroll But do Not Participate

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

    4 weeks

  • Average Total Time in Minutes Participants Spent Using App.

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

    4 weeks

  • Average Number of App Actions by 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.

    4 weeks

  • Average Days Participants Logged Medications.

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

    4 weeks

Secondary Outcomes (2)

  • System Usability Scale Scores

    4 weeks

  • Client Satisfaction Questionnaire Score

    4 weeks

Study Arms (1)

AllyQuest Pilot

EXPERIMENTAL

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

Interventions

AllyQuestBEHAVIORAL

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.

AllyQuest Pilot

Eligibility Criteria

Age16 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsassigned male at birth and self identify as male.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAlzheimer Disease

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Lisa Hightow Weidman, MD
Organization
UNC-Chapel Hill

Study Officials

  • Lisa Hightow-Weidman, MD, MPH

    UNC-CH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 27, 2017

Study Start

August 1, 2015

Primary Completion

January 3, 2017

Study Completion

January 3, 2017

Last Updated

July 11, 2018

Results First Posted

June 8, 2018

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share