HIV/AIDSNCT03049891
Pediatric Decentralization of ART in South Africa
An observational study of HIV/AIDS, run by Columbia University at 15 sites in South Africa.
Trial summary
The decentralization study will describe children taking antiretroviral therapy (ART) at a larger health facility in the Eastern Cape province of South Africa, between the years of 2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Data abstraction, Tracing questionnaire and Tier.net
- How many people
- 1,583 participants
- Where
- 15 sitesSouth Africa
- Study dates
- Nov 2015to Mar 2016
- 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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: This study consists of two parts. The first part is a retrospective records review of electronic and medical records of children starting ART at a large hospital facility 2004-2013 (no sampling or recruitment). We expect that 1600 children started ART during this period. The second part of the study will be a community tracing study of children who have been lost to follow-up, in which we will interview caregivers of children. We will randomly sample 75 patients who have been LTF will be generated using the data from the retrospective records review.
Who may be able to join
- HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.
- Legal caregiver (older than 18) a child who was included in the ART Outcomes Study that was found to be LTFU from DNH or from the down-referral facility.
Who cannot join
- Anyone not meeting inclusion criteria
- Tracing Study:
- Guardians who cannot be confirmed as the legal caregiver of the child
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Africa15 sites
Chatty Clinic
Port Elizabeth, Eastern Cape
Dora Nginza Hospital
Port Elizabeth, Eastern Cape
Empilweni TB Hospital
Port Elizabeth, Eastern Cape
Govan Mbeki Clinic
Port Elizabeth, Eastern Cape
Joe Slovo Clinic
Port Elizabeth, Eastern Cape
Kwadwesi Clinic
Port Elizabeth, Eastern Cape
Kwazakhele Clinic
Port Elizabeth, Eastern Cape
Kwazakhele Community Health Center
Port Elizabeth, Eastern Cape
Motherwell Community Health Center
Port Elizabeth, Eastern Cape
New Brighton Clinic
Port Elizabeth, Eastern Cape
New Brighton Community Health Center
Port Elizabeth, Eastern Cape
Soweto Clinic
Port Elizabeth, Eastern Cape
Walmer 14th Avenue Clinic
Port Elizabeth, Eastern Cape
West End Clinic
Port Elizabeth, Eastern Cape
Zwide Clinic
Port Elizabeth, Eastern Cape
About this study
Official title: Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
The decentralization study will describe children taking antiretroviral therapy (ART) at a larger health facility in the Eastern Cape province of South Africa, between the years of 2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure how many children stay in care and how many die, as well as their health status. The study will also compare whether children do better if they stay in care a large hospitals or if they get health care at smaller clinics. A second part of the study will find children in the community who have stopped coming for health care and find out what happened to them and what their health status is.
Read the detailed description
The investigators propose to conduct a two part study which will include a retrospective cohort study to examine care outcomes among pediatric patients 0-14 years of age initiated on antiretroviral therapy (ART) in 2004-2013 at a larger peri-urban health facility in the Eastern Cape province of South Africa. The study will be conducted at Dora Nginza Hospital (DNH). The outcomes measured in the study will include retention and mortality, as well as virologic suppression rates for children initiated on ART. In addition to reporting outcomes for all children with available data, the study will compare outcomes for children retained in care at DNH (where they initiated ART) to those children who were referred out after initiation for routine follow-up at community health clinics and primary care clinics ("down referred"). A second part of the study will trace pediatric patients in the community who have been lost to follow-up (LTF) to ascertain their outcomes after they left care at the health facility.
- Conditions
- HIV/AIDS
- Being tested
- Data abstraction, Tracing questionnaire, Tier.net
- Keywords
- Antiretroviral Therapy, Retention, Loss to Follow Up
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data abstractionOther
Also called NHLS (National Health Laboratory Service)
The investigators will abstract clinical data from down-referral sites and from NHLS to determine whether children made it to their down-referral sites or whether children are in care at a different facility.
Tracing questionnaireOther
The investigators will attempt to contact and visit caregivers of children who are determined to be LTF from DNH or from down-referral sites. If located and after providing consent, caregivers will be administered a tracing questionnaire, or a verbal autopsy if their child has died.
Tier.netOther
For all children who started ART at DNH between 2004 and 2013, the investigators will abstract data on these children from the electronic medical system in South Africa called Tier.net.
| Study group | Role | What they receive |
|---|---|---|
| Children down-referred from DNH | This group includes children who were transferred from DNH to a study facility. The investigators will first abstract data from the electronic data system 'Tier.net' for these children, which will tell us where they were down-referred. For children who were labeled as down-referred from DNH in Tier.net, data abstraction of the child's clinical data will be conducted at the down-referral site and from the National Health Laboratory Service (NHLS) data. Receives: Other: Data abstraction; Other: Tier.net | |
| Children LTF from DNH | This group includes children who began ART at DNH and were subsequently LTF. The investigators will first abstract data from the electronic data system 'Tier.net', which will classify them as LTF followed by examination of the the NHLS laboratory data to determine whether these children had received care at another facility since they were LTF. Receives: Other: Data abstraction; Other: Tier.net | |
| Caregivers of LTF | This group includes the caregivers of a subset of children in the 'LTF from DNH' and 'down-referred from DNH' groups. Among those children down-referred and LTF from DNH, the investigators will use their clinical and laboratory data to determine whether they are still receiving care or not. For children identified as LTF based on their abstracted data will be traced in order to contact their caregivers. If located, caregivers will be interviewed to ascertain if and why these children are no longer in care through a 'Tracing questionnaire'. Receives: Other: Tracing questionnaire | |
| DNH only | This group includes children who are still in care at DNH, died while in care at DNH, or were transferred to facilities from tier.net will not have any additional information collected other than what is recorded in the Tier.net database. Receives: Other: Tier.net |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children initiated on ART at DNH who are still in care
Measured: Baseline (single measure)
Secondary outcomes (3)
Proportion of children with hospitalization and/or death after ART initiation at DNH
Measured: Baseline (single measure)
Proportion of down-referred children retained in care at their down-referral facility.
Measured: Baseline (single measure)
Proportion of children who died or were LTF among those who remained at DNH and those down-referred
Measured: Baseline (single measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Retrospective
- Enrolment
- 1,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine J Abrams, MD, Principal investigator, ICAP at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049891
- Sponsor's protocol ID
- AAAO9854
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
- ClinicalTrials.gov ID
- NCT03049891
- Acronym / sponsor ID
- AAAO9854
- Conditions
- HIV/AIDS
- Keywords
- Antiretroviral Therapy, Retention, Loss to Follow Up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,583 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2017 (actual)
- 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 decentralization study will describe children taking antiretroviral therapy (ART) at a larger health facility in the Eastern Cape province of South Africa, between the years of 2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure how many children stay in care and how many die, as well as their health status. The study will also compare whether children do better if they stay in care a large hospitals or if they get health care at smaller clinics. A second part of the study will find children in the community who have stopped coming for health care and find out what happened to them and what their health status is.
Detailed description
The investigators propose to conduct a two part study which will include a retrospective cohort study to examine care outcomes among pediatric patients 0-14 years of age initiated on antiretroviral therapy (ART) in 2004-2013 at a larger peri-urban health facility in the Eastern Cape province of South Africa. The study will be conducted at Dora Nginza Hospital (DNH). The outcomes measured in the study will include retention and mortality, as well as virologic suppression rates for children initiated on ART. In addition to reporting outcomes for all children with available data, the study will compare outcomes for children retained in care at DNH (where they initiated ART) to those children who were referred out after initiation for routine follow-up at community health clinics and primary care clinics ("down referred"). A second part of the study will trace pediatric patients in the community who have been lost to follow-up (LTF) to ascertain their outcomes after they left care at the health facility.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children down-referred from DNH | – | Other: Data abstraction, Other: Tier.netThis group includes children who were transferred from DNH to a study facility. The investigators will first abstract data from the electronic data system 'Tier.net' for these children, which will tell us where they were down-referred. For children who were labeled as down-referred from DNH in Tier.net, data abstraction of the child's clinical data will be conducted at the down-referral site and from the National Health Laboratory Service (NHLS) data. |
| Children LTF from DNH | – | Other: Data abstraction, Other: Tier.netThis group includes children who began ART at DNH and were subsequently LTF. The investigators will first abstract data from the electronic data system 'Tier.net', which will classify them as LTF followed by examination of the the NHLS laboratory data to determine whether these children had received care at another facility since they were LTF. |
| Caregivers of LTF | – | Other: Tracing questionnaireThis group includes the caregivers of a subset of children in the 'LTF from DNH' and 'down-referred from DNH' groups. Among those children down-referred and LTF from DNH, the investigators will use their clinical and laboratory data to determine whether they are still receiving care or not. For children identified as LTF based on their abstracted data will be traced in order to contact their caregivers. If located, caregivers will be interviewed to ascertain if and why these children are no longer in care through a 'Tracing questionnaire'. |
| DNH only | – | Other: Tier.netThis group includes children who are still in care at DNH, died while in care at DNH, or were transferred to facilities from tier.net will not have any additional information collected other than what is recorded in the Tier.net database. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study consists of two parts. The first part is a retrospective records review of electronic and medical records of children starting ART at a large hospital facility 2004-2013 (no sampling or recruitment). We expect that 1600 children started ART during this period. The second part of the study will be a community tracing study of children who have been lost to follow-up, in which we will interview caregivers of children. We will randomly sample 75 patients who have been LTF will be generated using the data from the retrospective records review.
Key inclusion criteria (2 listed)
- HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.
- Legal caregiver (older than 18) a child who was included in the ART Outcomes Study that was found to be LTFU from DNH or from the down-referral facility.
Key exclusion criteria (3 listed)
- Anyone not meeting inclusion criteria
- Guardians who cannot be confirmed as the legal caregiver of the child
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 |
|---|---|---|
| Data abstractionAlso: NHLS (National Health Laboratory Service)The investigators will abstract clinical data from down-referral sites and from NHLS to determine whether children made it to their down-referral sites or whether children are in care at a different facility. | Other | Children LTF from DNH, Children down-referred from DNH |
| Tracing questionnaireThe investigators will attempt to contact and visit caregivers of children who are determined to be LTF from DNH or from down-referral sites. If located and after providing consent, caregivers will be administered a tracing questionnaire, or a verbal autopsy if their child has died. | Other | Caregivers of LTF |
| Tier.netFor all children who started ART at DNH between 2004 and 2013, the investigators will abstract data on these children from the electronic medical system in South Africa called Tier.net. | Other | Children LTF from DNH, Children down-referred from DNH, DNH only |
Primary outcome
Proportion of children initiated on ART at DNH who are still in care
Time frame: Baseline (single measure)
3 secondary outcomes
Proportion of children with hospitalization and/or death after ART initiation at DNH
Time frame: Baseline (single measure)
Proportion of down-referred children retained in care at their down-referral facility.
Time frame: Baseline (single measure)
Proportion of children who died or were LTF among those who remained at DNH and those down-referred
Time frame: Baseline (single measure)
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 10 Feb 2017.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Elaine J Abrams, MD principal investigator
ICAP at Columbia University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Columbia University at 15 sites in South Africa.
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 2 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Africa. 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?
Proportion of children initiated on ART at DNH who are still in care (time frame: Baseline (single measure)). 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 10 Feb 2017.