Epic Allies HIV ART Adherence Intervention
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|ClinicalTrials.gov Identifier: NCT02782130|
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Epic Allies App Intervention Behavioral: Epic Allies - Control Branch||Not Applicable|
Implementation of effective interventions for HIV care engagement is necessary to raise the percentage of people living with HIV/Acquired Immunodeficiency Syndrome (AIDS) who are virally suppressed and in continuous care. The ultimate goal of this study is to assess the effectiveness of a mobile phone app that utilizes game mechanics and social networking features to improve engagement in care, and ART uptake and adherence among HIV-positive YMSM and trans women who have sex with men. The high mobile phone ownership among adolescent and young adults supports using intervention tools based in these familiar available technologies. If successful, Epic Allies would be clinically attractive, as adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections and financially attractive, as reducing clinic visits and secondary infections. Epic Allies could also greatly impact public health as ART adherence reduces HIV infectivity and subsequently reduces HIV transmission.
This is a two-arm randomized-controlled trial (RCT). All subjects will be randomized either to the intervention arm and receive the Epic Allies intervention branch of the app or to the control arm and receive the phone-based notifications only control branch of the app. Randomization will occur in a 1:1 ratio within each of the two groups (new-to-care and ART-non-adherent) separately, with an equal number of subjects in the intervention and control arms. During the 26-week intervention phase, intervention arm subjects will receive the daily adherence reminders they set up through Epic Allies with tailored feedback for encouragement and reinforcement. Intervention arm subjects will have 24-hour access to all features of Epic Allies. The control arm subjects will receive weekly phone-based notifications to encourage them to view educational information presented in the app. Subjects will attend study visits at Week 13 (during intervention phase), Week 26 (end of intervention phase), and Week 39 (post-intervention phase). In-depth qualitative app satisfaction interviews with a subset of intervention arm subjects will also be conducted to evaluate acceptability of the app and its potential to improve engagement in care, uptake of ART, and ART adherence. Outcome measures will include engagement in care, ART uptake, ART adherence, viral load (VL) change, and VL suppression. The in-depth qualitative app satisfaction interview will assess intervention impact, acceptability, and long-term sustainability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Epic Allies: A Gaming Mobile Phone Application to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men (YMSM) and Trans Women Who Have Sex With Men|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||December 14, 2017|
Active Comparator: Intervention Group
Subjects randomized to the Epic Allies Intervention will download and install the intervention branch of the Epic Allies app and receive a tour of the app guided by site staff. During the 26-week intervention phase, intervention arm subjects will receive daily adherence reminders set up through Epic Allies with tailored feedback for encouragement and reinforcement. Intervention arm subjects will have 24-hour access to all features of Epic Allies and will receive supportive messages from other subjects on the intervention arm.
Behavioral: Epic Allies App Intervention
The Epic Allies app addresses barriers to ART adherence through:
Placebo Comparator: Control Group
Subjects randomized to the control arm will download and install the control branch of the Epic Allies app (phone-based notifications only) and be provided with instructions on using the app. During the 26-week intervention phase, the control arm subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.
Behavioral: Epic Allies - Control Branch
Subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.
- VL suppression at 13 weeks [ Time Frame: 13 weeks ]VL suppression at 13 weeks is defined as VL below the lower limit of detection (LLD) in the six-week window before the Week 13 visit.
- VL suppression at 26 weeks [ Time Frame: 26 weeks ]VL suppression at 26 weeks is defined as VL below the lower limit of detection (LLD) in the six-week window before the Week 26 visit.
- Self-reported ART adherence [ Time Frame: 13 weeks, 26 weeks, and 39 weeks ]
- Retention in HIV Care [ Time Frame: 13 weeks, 26 weeks, and 39 weeks ]
- VL suppression at 39 weeks [ Time Frame: 39 weeks ]VL suppression at 39 weeks is defined as VL below the lower limit of detection (LLD) in the six-week window before the Week 39 visit.
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): NCT02782130
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Stroger Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane Medical Center|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|Study Chair:||Lisa Hightow-Weidman, MD||University of North Carolina, Chapel Hill|