- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043769
Pediatric Enhanced Surveillance Study (PESS)
Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Amathole
-
East London, Amathole, South Africa
- Cecilia Makiwane Hospital
-
East London, Amathole, South Africa
- Frere Hospital
-
-
Nelson Mandela Bay
-
Port Elizabeth, Nelson Mandela Bay, South Africa
- Dora Ngiza Hospital
-
Port Elizabeth, Nelson Mandela Bay, South Africa
- Kwazakhele Community Health Center
-
Port Elizabeth, Nelson Mandela Bay, South Africa
- Motherwell Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Human immunodeficiency virus (HIV)-infected children accessing HIV care and treatment services in the Eastern Cape of South Africa are the population of interest for the overall study.
- Records review: All children with a record of care at the study facilities in the Wellness or antiretroviral (ART) clinic will form the study population.
- Prospective cohort: ART-naïve children receiving care at participating sites who have reached eligibility for ART and consent to participate will form the study population. The sample for the study will be a subset of all children enrolled and receiving care at these public health care facilities.
Description
Inclusion Criteria:
- The child is eligible for antiretroviral therapy (ART) initiation based on the South African Pediatric HIV guidelines.
- The child has documentation of being HIV-infected by a positive HIV-Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), detectable HIV ribonucleic acid (RNA) viral load or a positive HIV antibody test (>18 months of age).
- The child has no prior history of treatment with ART other than prophylaxis for preventing mother to child transmission (PMTCT) (may be initiating ART on day of enrollment in study).
- The child is between 1 month and 12 years of age.
- The parent or legal guardian provides written consent for participation.
- The child provides assent for participation based on South African guidance for minors.
Exclusion Criteria:
- Any subject not meeting all of the above inclusion criteria will not be eligible for the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Prospective Cohort
The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of children alive and in care at 12 and 24 months after treatment initiation
Time Frame: Up to 24 months
|
We will measure the proportion of children alive and in care at 12 and 24 months after treatment initiation amount prospective cohort participants through routine clinical and study visits.
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services
Time Frame: Up to 24 months
|
We will describe the proportion of the children enrolled in HIV care and treatment services at the study facilities who start treatment and are retained in care for 6, 12, 24, 36 and 48 months by reviewing clinical records at each facility.
|
Up to 24 months
|
Proportion of children lost to follow-up
Time Frame: Up to 24 months
|
We will describe the proportion of children lost to follow-up after enrollment in care and in those starting treatment by reviewing clinical records of study participants.
|
Up to 24 months
|
Proportion of children with documented deaths
Time Frame: Up to 24 months
|
We will describe proportion of children with documented deaths and causes of deaths and time to death (from enrollment) by reviewing clinical records of participants.
|
Up to 24 months
|
Proportion of children who are virologically suppressed
Time Frame: Up to 24 months
|
We will measure the proportion of children who are virologically suppressed (< 400 copies/mL, per South African National Guidelines) at 12 and 24* months after treatment initiation in the prospective cohort through routine clinical and study visits.
|
Up to 24 months
|
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts
Time Frame: Up to 24 months
|
We will measure the proportion of children, aged 2 to 5 years, on ART with CD4% <10% at 12, 24* months after treatment initiation and children older than 5 years on ART with CD4 count of < 100 at 12, 24 months after treatment initiation.
These outcomes will be measured in participants of the prospective cohort who will give additional blood samples during routine clinical care.
|
Up to 24 months
|
Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease
Time Frame: Up to 24 months
|
We will measure the proportion of children on ART progressing to WHO Stage 4 disease at 12 and 24 months after treatment initiation in the prospective cohort.
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elaine Abrams, MD, ICAP-NY, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- AAAI1736
- U2GPS001537 (U.S. NIH Grant/Contract)
- U262PS223540 (Other Grant/Funding Number: MCAP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Immunodeficiency Virus (HIV)
-
Merck Sharp & Dohme LLCWithdrawnHIV-1 | Immunodeficiency Virus Type 1, Human | Human Immunodeficiency Virus Type 1 | Human Immunodeficiency Virus 1
-
National Institute of Allergy and Infectious Diseases...CompletedHuman Immunodeficiency Virus (HIV) | Human Immunodeficiency Virus PreventionUnited States
-
RTI InternationalCenters for Disease Control and PreventionCompletedHuman Immunodeficiency Virus (HIV) PositiveUnited States
-
Bristol-Myers SquibbCompleted
-
Janssen-Cilag International NVCompletedHuman Immunodeficiency Virus (HIV) Infections | Acquired Immunodeficiency Syndrome (AIDS) VirusFrance, United Kingdom, Belgium, Germany, Spain, Switzerland, Denmark, Israel, Austria, Poland, Hungary, Sweden, Ireland
-
Merck Sharp & Dohme LLCRecruitingHuman Immunodeficiency Virus (HIV) InfectionUnited States, Mexico, Russian Federation, South Africa, Thailand
-
Janssen Inc.CompletedHuman Immunodeficiency Virus (HIV)Canada
-
Auritec PharmaceuticalsEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHuman Immunodeficiency Virus (HIV) ProphylaxisUnited States
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York University and other collaboratorsCompletedHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityMinistry of Health, SwazilandCompleted