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Trial record 38 of 640 for:    test AND point-of-care

Impact of Point-of-Care EID for HIV-Exposed Infants (POC-EID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03824067
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
UNITAID
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Brief Summary:
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

Condition or disease Intervention/treatment Phase
HIV/AIDS Infant Morbidity Pediatric HIV Infection Transmission, Perinatal Infection Diagnostic Test: Point of Care Early Infant Diagnosis Diagnostic Test: Standard of Care Early Infant Diagnosis Not Applicable

Detailed Description:

This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis (EID) on turn-around time from sample collection until notification of parents/caregivers of test result, linkage to care, and time to initiation of treatment, and early retention in HIV care (3-6 months) for those infected.

The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC EID project. As part of POC program implementation activities, in each country up to 50 EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health facilities. Project sites have been selected as part of the program implementation. In each country, 18 sites will be randomly selected as study sites for the impact evaluation.

Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. Quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of HIV-infected infants.

Qualitative data on feasibility and acceptability of POC will be derived from in-depth interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The design of this study is a cluster-randomized stepped wedge trial. This is whereby an intervention is rolled out sequentially to the study facilities over a number of time periods. The order in which the different clusters receive the intervention is determined at random and by the end of random allocation, all facilities will have received the intervention. Testing sites (determined from the list of all project facilities excluding pilot sites) will be randomized regarding timing of POC implementation; sites that serve as "hub" sites and their associated "spoke" sites will be given the same designation. The study will use a mixed method approach in data collection, and a qualitative component will also be conducted, including interviews and focus groups.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Impact of Point-of-Care Early Infant Diagnostic (EID) Testing on Timely Receipt of EID Results and Treatment Initiation in HIV-Exposed Children in Kenya and Zimbabwe
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care Early Infant Diagnosis
Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID
Diagnostic Test: Standard of Care Early Infant Diagnosis
Conventional laboratory based EID testing
Other Name: SOC EID

Experimental: Point of Care Early Infant Diagnosis
The intervention is Point of Care (POC) early infant diagnosis (EID) testing, where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Diagnostic Test: Point of Care Early Infant Diagnosis
HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Other Name: POC EID




Primary Outcome Measures :
  1. Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks [ Time Frame: 12 weeks ]
    The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing


Secondary Outcome Measures :
  1. Testing coverage for the 4-6 week indication [ Time Frame: 18 months ]
    Number of EID samples collected for 4-6 week indication divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing

  2. Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification [ Time Frame: 18 months ]
    Date of sample collection to the date that results were given to care giver

  3. Age of patient at test result notification for 4-6 week EID test indication [ Time Frame: 18 months ]
    HEIs date of birth, date of sample collection and date of result notification to care giver

  4. Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants [ Time Frame: 18 months ]
    Date positive result received at facility to the date the result was communicated to mother and date of ART initiation

  5. Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART [ Time Frame: 18 months ]
    Number of HIV-infected infants initiated on ART after 4-6 week EID test divided by the number of HIV-infected infants identified after 4-6 week EID test

  6. Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months [ Time Frame: 24 months ]
    Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
  • HEI under 12 weeks of age or their parents/caregivers
  • Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
  • Purposively selected caregivers of HEI for in-depth interviews
  • Focus groups with community members will not require participants to have sought testing for EID

Exclusion Criteria:

  • Participants not at selected study sites
  • For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
  • For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824067


Locations
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Kenya
Elizabeth Glaser Pediatric AIDS Foundation
Nairobi, Kenya
Zimbabwe
Elizabeth Glaser Pediatric AIDS Foundation
Harare, Zimbabwe
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
UNITAID
Investigators
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Principal Investigator: Emma Sacks, PhD Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Collins Odhiambo, MD Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Agnes Mahomva, MD Elizabeth Glaser Pediatric AIDS Foundation
Study Director: Jennifer Cohn, MD MPH Elizabeth Glaser Pediatric AIDS Foundation

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Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT03824067     History of Changes
Other Study ID Numbers: UNITAID EB21/RO8
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
HIV/AIDS
Point of Care
Early infant diagnosis
Health systems
Diagnostic tools
LMIC

Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases