HIV-infection/AidsNCT01140633
Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
An observational study of HIV-infection/Aids, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- HIV-infection/Aids
- How many people
- 46 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2010to Aug 2012
- 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: young children receiving HIV antiretroviral therapy in a rural African setting
Who may be able to join
- age 1 to 10 years
- HIV-infected, meeting Ugandan criteria for antiretroviral therapy
- living within 30 km of Mbarara, Uganda
Who cannot join
- lack of mobile-phone reception
Trial locations and contacts
1 site in 1 country.
About this study
Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.
This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.
Read the detailed description
See above.
- Conditions
- HIV-infection/Aids
- Keywords
- HIV/AIDS, pediatric, wireless adherence monitoring, HIV Infections
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of adherence
Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda.
Measured: Monthly adherence levels will be determined over the six-month study period.
Secondary outcomes (2)
Feasibility and acceptability of wireless adherence measures
Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures
Measured: Assessments will be made a the one-month time point.
Model of adherence behavior
Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting
Measured: Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AidsStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Jessica Haberer, MD, Massachusetts General Hospital
- Investigators
- Jessica E Haberer, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140633
- Sponsor's protocol ID
- 2009-P-001062
- Other IDs
- K23MH087228
- Status last verified
- Aug 2013
- First submitted
- 7 Jun 2010
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
- ClinicalTrials.gov ID
- NCT01140633
- Acronym / sponsor ID
- 2009-P-001062
- Conditions
- HIV-infection/Aids
- Keywords
- HIV/AIDS, pediatric, wireless adherence monitoring, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Jun 2010 (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.
Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.
This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.
Detailed description
See above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- young children receiving HIV antiretroviral therapy in a rural African setting
Key inclusion criteria (3 listed)
- age 1 to 10 years
- HIV-infected, meeting Ugandan criteria for antiretroviral therapy
- living within 30 km of Mbarara, Uganda
Key exclusion criteria (1 listed)
- lack of mobile-phone reception
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
Distribution of adherence
Time frame: Monthly adherence levels will be determined over the six-month study period.
Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda.
2 secondary outcomes
Feasibility and acceptability of wireless adherence measures
Time frame: Assessments will be made a the one-month time point.
Model of adherence behavior
Time frame: Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.
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 2 Sep 2013.
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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 E 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-infection/Aids, 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 3 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 2 Sep 2013. 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?
Distribution of adherence (time frame: Monthly adherence levels will be determined over the six-month study period.). 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 2 Sep 2013.