Youth mHealth Adherence Intervention for HIV+ YMSM

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092115
• Other study ID #: 15-012173
• Secondary ID: K23MH102128P30AI
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• HIV medication adherence app
A medication adherence mobile application for HIV+ youth. It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suppressed viral load at 3-months	Percentage of participants with suppressed HIV viral load (= 200 copies/mL) at the 3-month follow-up study visit.	3 months
Secondary	Self-reported medication adherence rates by participants at 3 months	Measure participants' self-reported rate of adherence at 3-month study visit using the AIDS Clinical Trials Group (ACTG) adherence 4-day recall question administered through computer-assisted self-interview (CASI) survey.	3 months
Secondary	Medication adherence measure using prescription refill information	Percentage of participants who refilled their ART medication determined from medical chart abstraction at 3-month study visit.	3 months
Secondary	Self-reported medication adherence rates by participants over 3-months within the medication adherence application	Percentage participants self-reported medication adherence over a 3-month period within the mHealth app where participants recorded yes/no on whether they adhered to their ART daily.	3 months
Secondary	Measure participant satisfaction of the medication adherence application at 3-months	Measure participant satisfaction with the medication adherence application at the 3-month study visit measured by a xx-item questionnaire that includes likert scales and open-ended qualitative questions administered through computer-assisted self-interview (CASI) survey.	3 months
Secondary	Suppressed viral load at 6-months	a. Percentage of participants with suppressed HIV viral load (= 200 copies/mL) at 6-months through medical chart abstraction to determine if participants remained virally suppressed or reached viral suppression since 3-months. No study visit for participant at 6-months, medical abstraction conducted by study team as labs are conducted as part of routine HIV care.	6 months