Epic Allies HIV ART Adherence Intervention

Completed · Not applicable

Conditions studied: HIV

In brief

This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability, impact, and long-term sustainability of the Epic Allies intervention application (app), a theory-based mobile app that utilizes game mechanics and social networking features to improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral suppression among HIV-positive young men who have sex with men (YMSM) and trans women who have sex with men. Subjects will be randomized to either the intervention branch of the Epic Allies app or the control branch of the app.

Key facts

Study ID

NCT02782130

Run by

University of North Carolina, Chapel Hill

People needed

146

Starts

2015-06-01

Expected to finish

2017-12-14

Last updated by the study team

2018-01-18

Who can join

Age: 16 and older, up to 24. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• To be considered eligible for enrollment, an individual must meet all the criteria listed below.
• Ages 16 years and 0 days through 24 years and 364 days, inclusive, at the time of signed informed consent or assent with parental/legal guardian permission, if applicable;
• Assigned male sex at birth, is of any gender identity, and self-reports a desire to engage or is engaging in sex with men;
• Has documentation of a VL collected within the 12 weeks prior to the Baseline visit that is greater than the LLD for the assay used to test the specimen;
• Be either:
• New-to-care: Newly entered HIV medical care within the 12 months prior to the Baseline visit; or
• ART-non-adherent: First entered HIV medical care more than 12 months prior to the Baseline visit;
• Has reliable daily access to an Android- or iOS-based smartphone with a data plan;
• Is able to speak and read English;
• Is willing and able to provide signed informed consent or assent; and
• Parent or legal guardian is willing to provide permission, if applicable.

You may not qualify if…

• To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
• Presence of active serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent/assent or complete the baseline CAPI survey*;
• Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent/assent or the baseline CAPI survey*;
• Intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the ability to give true informed/assent is impaired*; or
• At the time of the baseline CAPI survey, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the subject's ability to understand and answer the questions may be impaired or negatively impact the integrity of the research data*.
• NOTE: If consent/assent is obtained prior to enrollment and the Baseline visit date, assessment for these exclusion criteria must be performed again prior to administration of the baseline CAPI survey. If any are present during the Baseline visit, the subject cannot be enrolled; do not administer the CAPI survey. Reassessment of eligibility and enrollment may take place at a later date per the discretion of the treating clinician.

Where it is running

• University of South Florida — Tampa, Florida, United States
• Stroger Hospital of Cook County — Chicago, Illinois, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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