Improving Antiretroviral Medication Adherence Among HIV-infected Youth
1 other identifier
interventional
17
1 country
3
Brief Summary
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment. The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2013
CompletedApril 17, 2017
April 1, 2017
1.5 years
April 4, 2011
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electronically monitored (MEMS) antiretroviral medication adherence
The primary outcome will be antiretroviral medication adherence. Adherence will be measured through the medication event monitoring device(MEMS).
3 months
Study Arms (2)
Condition
NO INTERVENTIONIn the comparison condition, participants will receive MEMS only.
Positive STEPS
EXPERIMENTAL* Participants will receive one on one Positive STEPS counseling sessions (\~1 hour sessions per week for 5 weeks). * Participants will receive motivational reminders to take medications sent via text message to their cell phones. * Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Interventions
This intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.
Eligibility Criteria
You may qualify if:
- Age 13 to 24 years
- HIV-infected
- Currently taking antiretroviral therapy or prescribed medication for HIV
- Self-reported difficulties adhering to HIV medications in the past 3 months (i.e., \<95% compliant)
- If 18-24: Willing and able to provide informed consent
- If 13-17: Parent/guardian willing and able to provide parental permission and participant willing and able to provide assent
- Willing to attend all study visits
You may not qualify if:
- If 18-24:Unwilling or unable to provide informed consent
- If 13-17: Parent/guardian unwilling or unable to provide parental permission and participant willing and able to provide assent
- Has severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit your ability to participate (e.g. dementia)
- Has severe cognitive limitation that would limit your ability to comprehend the informed consent or assent (see Decisional Capacity Determination SOP)
- Unwilling to attend all study visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fenway Community Healthlead
- Boston Children's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- Harvard Medical School (HMS and HSDM)collaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
The Fenway Institute, Fenway Health
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J Mimiaga, ScD, MPH
Massachusetts General Hospital and Fenway Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
April 4, 2011
First Posted
May 4, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2013
Study Completion
March 6, 2013
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share