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

April 13, 2017 updated by: Matthew Mimiaga, Fenway Community Health

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.

Study Overview

Status

Completed

Conditions

HIV Infection

Detailed Description

This phase of the protocol focuses on setting up the infrastructure necessary for conducting the study, including hiring and training activities with study staff. This time will be spent conducting interviews and using these data to inform the development of the intervention protocol and adaptation of all Life-Steps intervention materials, including study assessment instruments, for HIV-infected youth.

The interview is a one-time event and will last for 1.5-2 hours. It has two components: a quantitative assessment and a qualitative discussion. After all participants have completed the informed consent and assent (if under the age of 18) processes, the research staff will administer a brief quantitative assessment that will ask questions related to demographics, medication adherence, sexual risk, substance use, and psychosocial condition. The second part of the interview will be an open discussion. The interviews will be conducted by a trained member of the research staff. The interviews will be informed by a pre-determined qualitative topic guide.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Children's Hospital Boston
  - Boston, Massachusetts, United States, 02215
    - Fenway Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-infected youth between the ages of 13 and 24

Description

Phase I

Inclusion Criteria:

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)

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perceived barriers and facilitators to adherence Time Frame: One-time qualitative interview	We will code the qualitative interview data for key themes that emerge with respect to adherence and intervention needs. 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.	One-time qualitative interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenway Community Health

Collaborators

Harvard Medical School (HMS and HSDM)

Massachusetts General Hospital

Boston Children's Hospital

Investigators

Principal Investigator: Matthew J. Mimiaga, ScD MPH, Fenway Health and Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

March 6, 2013

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria