Improving Antiretroviral Medication Adherence Among HIV-infected Youth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Fenway Community Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Children's Hospital Boston
Massachusetts General Hospital
Harvard University
Information provided by:
Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01347437
First received: April 4, 2011
Last updated: July 22, 2011
Last verified: April 2011

April 4, 2011
July 22, 2011
July 2011
April 2012   (final data collection date for primary outcome measure)
Electronically monitored (MEMS) antiretroviral medication adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The primary outcome will be antiretroviral medication adherence. Adherence will be measured through the medication event monitoring device(MEMS).
Same as current
Complete list of historical versions of study NCT01347437 on ClinicalTrials.gov Archive Site
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Not Provided
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Improving Antiretroviral Medication Adherence Among HIV-infected Youth
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II

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.

Aims:

  1. To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all study procedures and participant acceptability will be assessed.
  2. To explore whether the intervention leads to improved medication adherence among youth who receive the intervention, compared to a control group of youth who do not.

40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized into one of two arms (half and half). Randomization for all participants will occur after the beginning of the week 2 study visit. The duration of the study is 3 months

Randomization:

The investigators will conduct block randomization based on two categories of electronic adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence in order to be eligible for the study, although they may vary in the extent of non-adherence. Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points, the investigators may need to reconsider adherence categories over the course of the pilot study. The investigators will regularly examine the data to determine whether finer adherence categories are needed, and the investigators will adjust the categories if such a determination is made.

Intervention arm:

  • 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.

Comparison condition arm:

• Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV Infection
Behavioral: Positive STEPS
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.
  • No Intervention: Condition
    In the comparison condition, participants will receive MEMS only.
  • Experimental: Positive STEPS
    • 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.
    Intervention: Behavioral: Positive STEPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
13 Years to 24 Years
No
Contact: Rose F Closson, MSc 617-927-6189 rclosson@fenwayhealth.org
Contact: Madeline Wachman, BA 857-218-4970 madeline.wachman@childrens.harvard.edu
United States
 
NCT01347437
CFAR Adherence HIV Youth:2
No
Matthew J. Mimiaga, Massachusetts General Hospital
Fenway Community Health
  • Children's Hospital Boston
  • Massachusetts General Hospital
  • Harvard University
Principal Investigator: Matthew J Mimiaga, ScD, MPH Massachusetts General Hospital and Fenway Health
Fenway Community Health
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP