HIV Infection Clinical Trial
Official title:
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.
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