Youth mHealth Adherence Intervention for HIV+ YMSM



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:14 - 24
Updated:1/10/2019
Start Date:May 22, 2017
End Date:August 2019
Contact:Nadia L Dowshen, MD, MSHP
Email:dowshenn@email.chop.edu
Phone:267-443-7721

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Feasibility Testing of a Novel mHealth Intervention to Improve Adherence to Antiretroviral Therapy Among HIV+ Men Who Have Sex With Men (MSM) Youth

This study will help determine feasibility, acceptability, and preliminary efficacy of an app
for HIV medication adherence over a 3-month period. Participation is 3 months consisting of
two study visits: An initial study visit and a 3 month follow up visit with both visits
lasting about 60-90 minutes. The participant must use the study application (app) at least
once daily, and at study visits, must complete surveys.

Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and
fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral
suppression. Yet few interventions have been developed to address adherence in this
population with unique developmental/psychosocial needs. Mobile technology, which is
constantly consumed by youth, has the potential to deliver interventions that provide support
and feedback in real time as youth go about their daily lives.

This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention
(mHealth app) targeting medication adherence among HIV+ youth. It is a three-month
prospective feasibility trial to test a medication adherence mobile application consisting of
two study visits: baseline and 3-month follow up.

Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for
participant satisfaction with the app, demographics, and mental health and risk behaviors, as
well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill
data.

Inclusion Criteria:

1. Males (sex at birth male) age 14 to 24 years.

2. HIV-positive

3. Owns an Android smart phone

4. Within 1-month of initiating antiretroviral therapy (ART) medication, previously
failed ART and about to restart an ART regimen, or currently on ART having trouble
with adherence (defined as having a detectable viral load above 200 copies/ml).

5. MSM (men who have sex with men)

6. Receiving care at the Children's Hospital of Philadelphia (CHOP) Adolescent HIV clinic
at the time of the study

Exclusion Criteria:

1. Females (sex at birth; not gender)

2. Males age 13 years or younger or 25 years and older.

3. HIV-negative or status unknown

4. Not in care at the CHOP Adolescent HIV clinic at the time of the study.

5. Does not own an Android smart phone (iPhone, Blackberry, etc. phone users)

6. Is already ART adherent (defined as having an undetectable or suppressed, <200
copies/ml, viral load) or is not on or going to be on ART during the study period.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-3626
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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