Measurement of Adherence to ART in HIV-Infected Children in Uganda (The CHARTA Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868257
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : January 12, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital

Brief Summary:
This study will compare methods of determining whether HIV-infected children take their medications.

Condition or disease
HIV HIV Infections

Detailed Description:

HIV is a virus that weakens people's immune systems and can cause AIDS. Antiretroviral therapy (ART) is a treatment for HIV that combines different types of antiretroviral medications, but it must be taken throughout a person's life without missing doses to be effective. When people do miss doses, the HIV virus has an opportunity to develop resistance to the medications, making them less effective in the future. Reports indicate that as many as 50% of children infected with HIV who are living in resource-limited countries regularly miss doses of their ART. This study will test different methods for determining children's rates of adherence to ART medications. This will both define the exact magnitude of the problem and direct future efforts in increasing ART adherence in children.

Participation in this study will last 12 months. All children enrolled will undergo a series of assessments of medication adherence. At baseline and every month over the course of the study, researchers will make unannounced home visits to measure the amount of medicine that remains untaken by participants and to record how many times the electronic cap on participants' medication bottles have been removed. Participants with cell phones will also receive monthly phone calls during which they will be asked to measure the amount of their medicine that remains untaken. At study entry and after 6 and 12 months, researchers will also examine child participants' medical records and the results of their regularly scheduled blood tests. At these blood tests, an additional half teaspoon of blood, which may be used in future testing, will be collected and stored by the researchers. After 3, 6, 9, and 12 months, researchers will request to collect hair samples from child participants to test levels of HIV medications in the hair, but participation in this part of the study is optional.

Assessments of reasons for medication adherence will also be performed. At study entry and after 3, 6, 9, and 12 months, children and their parents will complete questionnaires about their understanding of HIV medicines and HIV infection, motivation for the child to take medications, behaviors related to taking medications, and basic personal information. One and 7 months after study entry, some parent participants will also complete interviews with study staff about giving HIV medicines to their children.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Adherence to ART in HIV-Infected School-Aged Children in Uganda
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

CHARTA study cohort
Primarily 5- to 10-year-old Ugandan children with HIV or AIDS who are taking ART, with some 1- to 4-year-olds included because of recent trends in treating younger children

Primary Outcome Measures :
  1. Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence [ Time Frame: Measured monthly for 12 months ]

Secondary Outcome Measures :
  1. Correlation of median ART adherence levels among the multiple measures and with HIV RNA [ Time Frame: Measured after 1 year ]

Biospecimen Retention:   Samples With DNA
Plasma samples to repeat HIV viral load testing, in the case of processing errors. If these samples are not needed, they may be used for immunologic or viral resistance testing at a future date.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children recruited from the outpatient Children's HIV/AIDS Care Clinic at the Mbarara University Teaching Hospital in rural, southwestern Uganda

Inclusion Criteria:

  • HIV-infected
  • Receiving highly active antiretroviral therapy (HAART) through the Children's HIV/AIDS Care Clinic
  • Resident in the Mbarara district, defined as living within 30 km or a 2-hour driving radius of the city of Mbarara
  • Plans to stay within the Mbarara district for the next year

Exclusion Criteria:

  • Attendance at a boarding school

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868257

Mbarara University of Science and Technology
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Jessica Haberer, MD, MS Massachusetts General Hospital

Responsible Party: Jessica Haberer, MD, Research Scientist/Assistant in Health Decision Sciences, Massachusetts General Hospital Identifier: NCT00868257     History of Changes
Other Study ID Numbers: R21MH083306 ( U.S. NIH Grant/Contract )
R21MH083306 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Jessica Haberer, MD, Massachusetts General Hospital:
Adherence to Antiretroviral Therapy
Resource Limited Setting
Treatment experienced

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