Youth mHealth Adherence Intervention for HIV+ YMSM

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: HIV

Treatments: Device: HIV medication adherence app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03092115

K23MH102128 (U.S. NIH Grant/Contract)

15-012173

P30AI045008 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 14 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

HIV medication adherence app

Experimental group

Description:

Youth in this arm will receive a medication adherence application to help them remember to take their HIV treatment medication (antiretroviral therapy) as a supplement to current HIV standard of care.

Treatment:

Device: HIV medication adherence app