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Impact of Point-of-Care EID for HIV-Exposed Infants

NCT03824067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9539

Last updated 2021-02-05

No results posted yet for this study

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.

Conditions

  • HIV/AIDS
  • Infant Morbidity
  • Pediatric HIV Infection
  • Transmission, Perinatal Infection

Interventions

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.

DIAGNOSTIC_TEST

Standard of Care Early Infant Diagnosis

Conventional laboratory based EID testing

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Emma Sacks, PhD · George Washington University School of Public Health

  • Collins Odhiambo, MD · Elizabeth Glaser Pediatric Aids Foundation - Kenya

  • Agnes Mahomva, MD · Elizabeth Glaser Pediatric Aids Foundation - Zimbabwe

  • Jennifer Cohn, MD MPH · Elizabeth Glaser Pediatric AIDS Foundation

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-10-30
Completion
2019-10-31

Countries

  • Kenya
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824067 on ClinicalTrials.gov