This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Boston Children’s Hospital
Harvard Medical School
Information provided by (Responsible Party):
Matthew Mimiaga, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01253850
First received: December 2, 2010
Last updated: April 13, 2017
Last verified: April 2017
  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
HIV Infection

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

Resource links provided by NLM:


Further study details as provided by Matthew Mimiaga, Fenway Community Health:

Primary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: August 2010
Study Completion Date: March 6, 2013
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Fenway Community Health
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Massachusetts General Hospital
Boston Children’s Hospital
Harvard Medical School
Investigators
Principal Investigator: Matthew J. Mimiaga, ScD MPH Fenway Health and Massachusetts General Hospital
  More Information

Responsible Party: Matthew Mimiaga, Research Scientist, Fenway Community Health
ClinicalTrials.gov Identifier: NCT01253850     History of Changes
Other Study ID Numbers: CFAR Adherence HIV Youth:1
Study First Received: December 2, 2010
Last Updated: April 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew Mimiaga, Fenway Community Health:
hiv
antiretroviral
adherence
adolescent

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

ClinicalTrials.gov processed this record on August 23, 2017