NCT03824067

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,539

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 5, 2021

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

January 25, 2019

Last Update Submit

February 3, 2021

Conditions

HIV/AIDSInfant MorbidityPediatric HIV InfectionTransmission, Perinatal Infection

Keywords

HIV/AIDSPoint of CareEarly infant diagnosisHealth systemsDiagnostic toolsLMIC

Outcome Measures

Primary Outcomes (1)

  • Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 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

    12 weeks

Secondary Outcomes (6)

  • Testing coverage for the 4-6 week indication

    18 months

  • Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification

    18 months

  • Age of patient at test result notification for 4-6 week EID test indication

    18 months

  • Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants

    18 months

  • Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care Early Infant Diagnosis

ACTIVE COMPARATOR

Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID

Diagnostic Test: Standard of Care Early Infant Diagnosis

Point of Care Early Infant Diagnosis

EXPERIMENTAL

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

Interventions

Point of Care Early Infant DiagnosisDIAGNOSTIC_TEST

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.

Also known as: POC EID
Point of Care Early Infant Diagnosis
Standard of Care Early Infant DiagnosisDIAGNOSTIC_TEST

Conventional laboratory based EID testing

Also known as: SOC EID
Standard of Care Early Infant Diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elizabeth Glaser Pediatric AIDS Foundation

Nairobi, Kenya

Location

Elizabeth Glaser Pediatric AIDS Foundation

Harare, Zimbabwe

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Emma Sacks, PhD

    George Washington University School of Public Health

    PRINCIPAL INVESTIGATOR

  • Collins Odhiambo, MD

    Elizabeth Glaser Pediatric Aids Foundation - Kenya

    PRINCIPAL INVESTIGATOR

  • Agnes Mahomva, MD

    Elizabeth Glaser Pediatric Aids Foundation - Zimbabwe

    PRINCIPAL INVESTIGATOR

  • Jennifer Cohn, MD MPH

    Elizabeth Glaser Pediatric AIDS Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 31, 2019

Study Start

August 1, 2017

Primary Completion

October 30, 2019

Study Completion

October 31, 2019

Last Updated

February 5, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)ZI(1)