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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Fenway Community Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Massachusetts General Hospital
Children's Hospital Boston
Harvard University
Information provided by:
Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01253850
First received: December 2, 2010
Last updated: July 22, 2011
Last verified: April 2011
  Purpose

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.


Condition Phase
HIV Infection
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • perceived barriers and facilitators to adherence [ Time Frame: One-time qualitative interview ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected youth between the ages of 13 and 24

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253850

Locations
United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Fenway Community Health
Massachusetts General Hospital
Children's Hospital Boston
Harvard University
Investigators
Principal Investigator: Matthew J. Mimiaga, ScD MPH Fenway Health and Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Matthew J. Mimiaga, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01253850     History of Changes
Other Study ID Numbers: CFAR Adherence HIV Youth:1
Study First Received: December 2, 2010
Last Updated: July 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Fenway Community Health:
hiv
antiretroviral
adherence
adolescent

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014