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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00868257
First received: March 23, 2009
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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


Condition
HIV
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Adherence to ART in HIV-Infected School-Aged Children in Uganda

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence [ Time Frame: Measured monthly for 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of median ART adherence levels among the multiple measures and with HIV RNA [ Time Frame: Measured after 1 year ] [ Designated as safety issue: No ]

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.


Enrollment: 120
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
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

Criteria

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
  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: NCT00868257

Locations
Uganda
Mbarara University of Science and Technology
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jessica Haberer, MD, MS Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jessica Haberer, MD, Research Scientist/Assistant in Health Decision Sciences, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00868257     History of Changes
Other Study ID Numbers: R21 MH083306, R21MH083306
Study First Received: March 23, 2009
Last Updated: January 11, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
AIDS
Adherence to Antiretroviral Therapy
Pediatric
Resource Limited Setting
Treatment experienced

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

ClinicalTrials.gov processed this record on October 21, 2014