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
|Condition or disease||Intervention/treatment||Phase|
|HIV||Device: HIV medication adherence app||Not Applicable|
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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Nadia L Dowshen, MD, MSHPfirstname.lastname@example.org|
|Contact: Susan Lee, MPHemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nadia L Dowshen, MD, MSHP 215-590-3626 firstname.lastname@example.org|
|Principal Investigator:||Nadia L Dowshen, MD, MSHP||Children's Hospital of Philadelphia|