Trial record 5 of 39 for:    " March 23, 2011":" April 22, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Behavioral: Positive STEPS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347437

Contacts
Contact: Rose F Closson, MSc 617-927-6189 rclosson@fenwayhealth.org
Contact: Madeline Wachman, BA 857-218-4970 madeline.wachman@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Madeline Wachman, BA    857-218-4970    madeline.wachman@children.harvard.edu   
Contact: Laurel Sticklor, BA    857-218-4077    laurel.sticklor@childrens.harvard.edu   
Principal Investigator: Laura M Bogart, PhD         
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
The Fenway Institute, Fenway Health Not yet recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Children's Hospital Boston
Massachusetts General Hospital
Harvard University
Investigators
Principal Investigator: Matthew J Mimiaga, ScD, MPH Massachusetts General Hospital and Fenway Health
  More Information

Additional Information:
No publications provided

Responsible Party: Matthew J. Mimiaga, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01347437     History of Changes
Other Study ID Numbers: CFAR Adherence HIV Youth:2
Study First Received: April 4, 2011
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fenway Community Health:
HIV
antiretroviral medication
adherence
adolescent

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014