HIVNCT00868257
Measurement of Adherence to ART in HIV-Infected Children in Uganda (The CHARTA Study)
An observational study of HIV and HIV Infections, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
This study will compare methods of determining whether HIV-infected children take their medications. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- HIV, HIV Infections
- How many people
- 120 participants
- Where
- 1 siteUganda
- Study dates
- Jul 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children recruited from the outpatient Children's HIV/AIDS Care Clinic at the Mbarara University Teaching Hospital in rural, southwestern Uganda
Who may be able to join
- 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
Who cannot join
- Attendance at a boarding school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Adherence to ART in HIV-Infected School-Aged Children in Uganda
This study will compare methods of determining whether HIV-infected children take their medications.
Read the 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.
- Conditions
- HIV, HIV Infections
- Keywords
- AIDS, Adherence to Antiretroviral Therapy, Pediatric, Resource Limited Setting, Treatment experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence
Measured: Measured monthly for 12 months
Secondary outcomes (1)
Correlation of median ART adherence levels among the multiple measures and with HIV RNA
Measured: Measured after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Haberer, MD, Massachusetts General Hospital
- Investigators
- Jessica Haberer, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868257
- Sponsor's protocol ID
- R21MH083306
- Other IDs
- R21MH083306
- Status last verified
- Jan 2012
- First submitted
- 23 Mar 2009
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Adherence to ART in HIV-Infected School-Aged Children in Uganda
- ClinicalTrials.gov ID
- NCT00868257
- Acronym / sponsor ID
- R21MH083306
- Conditions
- HIV, HIV Infections
- Keywords
- AIDS, Adherence to Antiretroviral Therapy, Pediatric, Resource Limited Setting, Treatment experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare methods of determining whether HIV-infected children take their medications.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children recruited from the outpatient Children's HIV/AIDS Care Clinic at the Mbarara University Teaching Hospital in rural, southwestern Uganda
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Attendance at a boarding school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence
Time frame: Measured monthly for 12 months
1 secondary outcome
Correlation of median ART adherence levels among the multiple measures and with HIV RNA
Time frame: Measured after 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Haberer, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and HIV Infections, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median antiretroviral therapy (ART) adherence levels for multiple measures of adherence (time frame: Measured monthly for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.