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

Completed

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 first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.

Key facts

Study ID

NCT01253850

Run by

Fenway Community Health

People needed

31

Starts

2010-08-01

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 and aware of HIV-infection status
• Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in the past 6 months, or a medical provider has recommended antiretroviral medications within the last 6 months
• Willing and able to provide informed consent or assent (if under the age of 18)

You may not qualify if…

• Not willing or able to provide informed consent or assent (if under the age of 18)
• Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
• Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
• Phase II
• Inclusion Criteria:
• Age 13-24 years
• HIV-infected and aware of HIV-infection status
• Currently taking antiretroviral therapy
• Self-reported difficulties adhering to HIV medications in the past 3 months
• Self-identify as heterosexual or LGB
• Willing and able to provide informed consent/consent of parent/guardian if under the age of 18
• Exclusion Criteria:
• Not willing or able to provide informed consent or assent (if under the age of 18)
• Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
• Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.

Where it is running

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

Full record on ClinicalTrials.gov

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