HIVNCT02782130
Epic Allies HIV ART Adherence Intervention
A study testing Epic Allies App Intervention in people with HIV, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 24 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- Epic Allies App Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2015to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Tulane Medical Center
New Orleans, Louisiana, 70112
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Epic Allies App Intervention, Epic Allies - Control Branch
- Keywords
- HIV, YMSM, Trans women, ART Adherence, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epic Allies App InterventionBehavioural
The Epic Allies app addresses barriers to ART adherence through:
- Users track health progress through an interactive dashboard, logging daily adherence for those on ART and, optionally, exercise, smoking, alcohol and drug use, and mood. Those not on ART will rate how close they are to getting on it.
- Users pick medication reminder timing. The app sends weekly messages to users based on adherence progress and other tracked behaviors.
- A key part of the app is contact between users to foster a setting that supports norms for medication-taking, reducing stigma related to HIV status and ART use. Users send and receive encouragement to spur behavior change, recognize positive behaviors, and inspire others to reach an adherence goal.
- Users progress through Epic Allies' virtual world, creating allies with other users.
- The Daily Dose newspaper has content to improve HIV/ART knowledge, promote disease management and increase drive and self-efficacy.
Epic Allies - Control BranchBehavioural
Subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 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. Receives: Behavioral: Epic Allies App Intervention |
| Control Group | Placebo comparator | 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. Receives: Behavioral: Epic Allies - Control Branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
VL suppression at 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.
Measured: 13 weeks
VL suppression at 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.
Measured: 26 weeks
Secondary outcomes (3)
Self-reported ART adherence
Measured: 13 weeks, 26 weeks, and 39 weeks
Retention in HIV Care
Measured: 13 weeks, 26 weeks, and 39 weeks
VL suppression at 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.
Measured: 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lisa Hightow-Weidman, MD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782130
- Sponsor's protocol ID
- ATN 132
- Other IDs
- 5R44MH102096-03
- Status last verified
- Jan 2018
- First submitted
- 10 Nov 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hightow-Weidman L, Muessig KE, Egger JR, Vecchio A, Platt A. Epic Allies: A Gamified Mobile App to Improve Engagement in HIV Care and Antiretroviral Adherence among Young Men Who have Sex with Men. AIDS Behav. 2021 Aug;25(8):2599-2617. doi: 10.1007/s10461-021-03222-y. Epub 2021 Mar 19.
PubMed 33740213LeGrand S, Muessig KE, Platt A, Soni K, Egger JR, Nwoko N, McNulty T, Hightow-Weidman LB. Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 5;7(4):e94. doi: 10.2196/resprot.8811.
PubMed 29622527
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02782130
- Acronym / sponsor ID
- ATN 132
- Conditions
- HIV
- Keywords
- HIV, YMSM, Trans women, ART Adherence, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Epic Allies App InterventionSubjects 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. |
| Control Group | Placebo comparator | Behavioral: Epic Allies - Control BranchSubjects 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (6 listed)
- 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*.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epic Allies App InterventionThe Epic Allies app addresses barriers to ART adherence through: 1. Users track health progress through an interactive dashboard, logging daily adherence for those on ART and, optionally, exercise, smoking, alcohol and drug use, and mood. Those not on ART will rate how close they are to getting on it. 2. Users pick medication reminder timing. The app sends weekly messages to users based on adherence progress and other tracked behaviors. 3. A key part of the app is contact between users to foster a setting that supports norms for medication-taking, reducing stigma related to HIV status and ART use. Users send and receive encouragement to spur behavior change, recognize positive behaviors, and inspire others to reach an adherence goal. 4. Users progress through Epic Allies' virtual world, creating allies with other users. 5. The Daily Dose newspaper has content to improve HIV/ART knowledge, promote disease management and increase drive and self-efficacy. | Behavioural | Intervention Group |
| Epic Allies - Control BranchSubjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app. | Behavioural | Control Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 33740213Hightow-Weidman L, Muessig KE, Egger JR, Vecchio A, Platt A. Epic Allies: A Gamified Mobile App to Improve Engagement in HIV Care and Antiretroviral Adherence among Young Men Who have Sex with Men. AIDS Behav. 2021 Aug;25(8):2599-2617. doi: 10.1007/s10461-021-03222-y. Epub 2021 Mar 19.
- Derived from this study: PubMed 29622527LeGrand S, Muessig KE, Platt A, Soni K, Egger JR, Nwoko N, McNulty T, Hightow-Weidman LB. Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 5;7(4):e94. doi: 10.2196/resprot.8811.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hightow-Weidman, MD study chair
University of North Carolina, Chapel Hill
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epic Allies App Intervention in people with HIV, run by University of North Carolina, Chapel Hill at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VL suppression at 13 weeks (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782130, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.