Improving Antiretroviral Medication Adherence Among HIV-infected Youth

Completed · Not applicable

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT01347437

Run by

Fenway Community Health

People needed

17

Starts

2011-07-01

Expected to finish

2013-03-06

Last updated by the study team

2017-04-17

Who can join

Age: 13 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• The Fenway Institute, Fenway Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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