Improving Antiretroviral Medication Adherence Among HIV-infected Youth

HIV Infection Clinical Trial

Official title:

Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347437
• Other study ID #: CFAR Adherence HIV Youth:2
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: April 13, 2017
• Start date: July 2011
• Est. completion date: March 6, 2013

Study information

• Verified date: April 2017
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 6, 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Fenway Institute, Fenway Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Fenway Community Health	Boston Children’s Hospital, Harvard Medical School, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The Fenway Institute