Clinical trial NCT03092115: Youth mHealth Adherence Intervention for HIV+ YMSM
Official title: Feasibility Testing of a Novel mHealth Intervention to Improve Adherence to Antiretroviral Therapy Among HIV+ Men Who Have Sex With Men (MSM) Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Men who have sex with men (MSM)
mHealth
antiretroviral therapy (ART)
native android app
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-03-27
Enrollment: 6
Sex: MALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Suppressed viral load at 3-months
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported medication adherence rates by participants at 3 months
timeFrame: 3 months
measure: Medication adherence measure using prescription refill information
timeFrame: 3 months
measure: Self-reported medication adherence rates by participants over 3-months within the medication adherence application
timeFrame: 3 months
measure: Measure participant satisfaction of the medication adherence application at 3-months
timeFrame: 3 months
measure: Suppressed viral load at 6-months
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Nadia L Dowshen, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: