HIV InfectionsNCT00134602
Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children
A study testing Needs assessment followed by tailored intervention in people with HIV Infections, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV) adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention group) from baseline to 4 months… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Needs assessment followed by tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2003to Oct 2008
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with a child between the ages of 5 and 12 years old who is HIV-infected and who receives care at participating hospitals
- Informed consent for and assent from the child
- Informed consent for the primary caregiver (person responsible for most of the child's medication delivery) must be obtained. The parent/legal guardian must be able to give informed consent and willing to comply with protocol requirements.
- The HIV-infected child must be currently prescribed an antiretroviral therapy regimen.
Who cannot join
- The child or caregiver cannot respond to self-report questions because of cognitive impairments.
- The child receives home health care in which the home health care aide dispenses all of the child's medication (essentially resulting in directly observed therapy for that child).
- The child and/or the caretaker does not speak English or Spanish.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jacobi Medical Center
The Bronx, New York, 10461
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Howard University Hospital, Department of Pediatrics
Washington D.C., District of Columbia, 20060
About this study
Official title: An Intervention to Promote Adherence to Antiretroviral Medications Among HIV-infected Children 5-12 Years of Age
The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV) adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention group) from baseline to 4 months post-intervention.
Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying and evaluating predictors and/or mediators of adherence; studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population; and evaluating the relationship between the amount of intervention received (i.e., number of hours/number of sessions) and changes in adherence.
Read the detailed description
The objective of this research is to develop and evaluate an intervention to promote adherence to HIV-medications among children aged 5-12 years. The research will be conducted at Jacobi Medical Center in the Bronx, NY; Children's National Medical Center in Washington, DC; and at Howard University Hospital in Washington, DC. The research will employ a randomized case control study design. Participants (dyads composed of an HIV-infected child and his/her primary caregiver) will be recruited from eligible families within each site's HIV clinic. After the study is explained and informed consent and assent (where applicable) are obtained, participants will be randomly assigned to either the enhanced intervention group (cases) or the minimal intervention group (controls). Participants assigned to the enhanced intervention group will receive a multi-component intervention, specifically tailored to their family's needs, which includes a maximum of 24 hours of contact conducted over a period of up to 12-weeks, and a 1-3 hour booster session approximately six weeks after the intervention phase is completed.
The enhanced intervention will be coordinated by an onsite Adherence Coordinator (AC) and implemented primarily by the AC or another member of the study staff. Participants assigned to the comparison group will receive a minimal intervention that will consist of an educational video and health education pamphlets about general health. All participants will continue to receive the standard-of-care at their respective sites during the study period. Assessments of all participants will be done at baseline (Assessment A), 1 month (Assessment B), and 4 months (Assessment C) following the intervention. Each assessment will include an interview to collect the following information from families:
- socio-demographic data;
- parental/child report of child's medication taking or adherence (self-reported adherence);
- mental health functioning (of parents and child, using standardized measures);
- HIV (of parents) and medication knowledge (of parents and child);
- medical review of child's hospital chart.
The baseline assessment of adherence to medications will include electronic recording of medication taking via a MEMS® cap done over a four-week period. Ongoing electronic assessment of adherence will occur for the duration of the study. Pharmacy refill data will also be obtained for a portion of the study participants for whom data are available.
- Conditions
- HIV Infections
- Being tested
- Needs assessment followed by tailored intervention
- Keywords
- HIV infection, antiretroviral therapy, adherence, pediatric
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needs assessment followed by tailored interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved adherence to antiretroviral treatment regimen
Secondary outcomes (2)
Improved viral load
Improved CD4 count
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startApr 2003
- Primary completionJan 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Jacobi Medical Center, Children's National Research Institute, Howard University
- Responsible party
- Sponsor
- Investigators
- Andrew Wiznia, MD, Principal investigator, Jacobi Medical Center, Bronx, NYTamara Rakusan, MD, Principal investigator, Children's National Research InstituteSohail Rana, MD, Principal investigator, Howard University Hospital, Pediatrics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134602
- Sponsor's protocol ID
- CDC-NCHSTP-3660
- Other IDs
- U64/CCU219540, U64/CCU319449
- Status last verified
- Sep 2012
- First submitted
- 24 Aug 2005
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Promote Adherence to Antiretroviral Medications Among HIV-infected Children 5-12 Years of Age
- ClinicalTrials.gov ID
- NCT00134602
- Acronym / sponsor ID
- CDC-NCHSTP-3660
- Conditions
- HIV Infections
- Keywords
- HIV infection, antiretroviral therapy, adherence, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Jacobi Medical Center, Children's National Research Institute, Howard University
- Study start
- Apr 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 25 Aug 2005 (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.
The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV) adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention group) from baseline to 4 months post-intervention.
Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying and evaluating predictors and/or mediators of adherence; studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population; and evaluating the relationship between the amount of intervention received (i.e., number of hours/number of sessions) and changes in adherence.
Detailed description
The objective of this research is to develop and evaluate an intervention to promote adherence to HIV-medications among children aged 5-12 years. The research will be conducted at Jacobi Medical Center in the Bronx, NY; Children's National Medical Center in Washington, DC; and at Howard University Hospital in Washington, DC. The research will employ a randomized case control study design. Participants (dyads composed of an HIV-infected child and his/her primary caregiver) will be recruited from eligible families within each site's HIV clinic. After the study is explained and informed consent and assent (where applicable) are obtained, participants will be randomly assigned to either the enhanced intervention group (cases) or the minimal intervention group (controls). Participants assigned to the enhanced intervention group will receive a multi-component intervention, specifically tailored to their family's needs, which includes a maximum of 24 hours of contact conducted over a period of up to 12-weeks, and a 1-3 hour booster session approximately six weeks after the intervention phase is completed.
The enhanced intervention will be coordinated by an onsite Adherence Coordinator (AC) and implemented primarily by the AC or another member of the study staff. Participants assigned to the comparison group will receive a minimal intervention that will consist of an educational video and health education pamphlets about general health. All participants will continue to receive the standard-of-care at their respective sites during the study period. Assessments of all participants will be done at baseline (Assessment A), 1 month (Assessment B), and 4 months (Assessment C) following the intervention. Each assessment will include an interview to collect the following information from families:
- socio-demographic data;
- parental/child report of child's medication taking or adherence (self-reported adherence);
- mental health functioning (of parents and child, using standardized measures);
- HIV (of parents) and medication knowledge (of parents and child);
- medical review of child's hospital chart.
The baseline assessment of adherence to medications will include electronic recording of medication taking via a MEMS® cap done over a four-week period. Ongoing electronic assessment of adherence will occur for the duration of the study. Pharmacy refill data will also be obtained for a portion of the study participants for whom data are available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Families with a child between the ages of 5 and 12 years old who is HIV-infected and who receives care at participating hospitals
- Informed consent for and assent from the child
- Informed consent for the primary caregiver (person responsible for most of the child's medication delivery) must be obtained. The parent/legal guardian must be able to give informed consent and willing to comply with protocol requirements.
- The HIV-infected child must be currently prescribed an antiretroviral therapy regimen.
Key exclusion criteria (3 listed)
- The child or caregiver cannot respond to self-report questions because of cognitive impairments.
- The child receives home health care in which the home health care aide dispenses all of the child's medication (essentially resulting in directly observed therapy for that child).
- The child and/or the caretaker does not speak English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needs assessment followed by tailored intervention | Behavioural | – |
Primary outcome
Improved adherence to antiretroviral treatment regimen
2 secondary outcomes
Improved viral load
Improved CD4 count
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 27 Sep 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.
Andrew Wiznia, MD principal investigator
Jacobi Medical Center, Bronx, NY
Tamara Rakusan, MD principal investigator
Children's National Research Institute
Sohail Rana, MD principal investigator
Howard University Hospital, Pediatrics Department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needs assessment followed by tailored intervention in people with HIV Infections, run by Centers for Disease Control and Prevention at 3 sites in United States.
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 3 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 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Improved adherence to antiretroviral treatment regimen. 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 27 Sep 2012.