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Trial record 5 of 230 for:    HIV [CONDITION] AND ((anti-hiv OR antiretroviral) AND medicines) [TREATMENT] | Recruiting, Not yet recruiting, Available Studies

Youth mHealth Adherence Intervention for HIV+ YMSM

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ClinicalTrials.gov Identifier: NCT03092115
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
HIV Device: HIV medication adherence app Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV medication adherence app
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.
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.




Primary Outcome Measures :
  1. Suppressed viral load at 3-months [ Time Frame: 3 months ]
    Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at the 3-month follow-up study visit.


Secondary Outcome Measures :
  1. Self-reported medication adherence rates by participants at 3 months [ Time Frame: 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.

  2. Medication adherence measure using prescription refill information [ Time Frame: 3 months ]
    Percentage of participants who refilled their ART medication determined from medical chart abstraction at 3-month study visit.

  3. Self-reported medication adherence rates by participants over 3-months within the medication adherence application [ Time Frame: 3 months ]
    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.

  4. Measure participant satisfaction of the medication adherence application at 3-months [ Time Frame: 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.

  5. Suppressed viral load at 6-months [ Time Frame: 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.



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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092115


Contacts
Contact: Nadia L Dowshen, MD, MSHP 267-443-7721 dowshenn@email.chop.edu
Contact: Susan Lee, MPH 267-426-1382 lees8@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nadia L Dowshen, MD, MSHP    215-590-3626    dowshenn@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Nadia L Dowshen, MD, MSHP Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03092115     History of Changes
Other Study ID Numbers: 15-012173
K23MH102128 ( U.S. NIH Grant/Contract )
P30AI045008 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data will not be shared with other researchers. If shared, datasets will be deidentified of participant health information.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:
Men who have sex with men (MSM)
mHealth
antiretroviral therapy (ART)
native android app