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

NCT00868257 | Completed

• 1 other identifier: R21MH083306
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV; HIV Infections

Keywords

AIDS; Adherence to Antiretroviral Therapy; Pediatric; Resource Limited Setting; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence

  Measured monthly for 12 months

Secondary Outcomes (1)

• Correlation of median ART adherence levels among the multiple measures and with HIV RNA

  Measured after 1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Attendance at a boarding school

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

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.

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Jessica Haberer, MD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist/Assistant in Health Decision Sciences

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

UG (1)