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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Infant Morbidity; Pediatric HIV Infection; Transmission, Perinatal Infection
• Intervention / Treatment: Diagnostic test: Standard of Care Early Infant Diagnosis; Diagnostic test: Point of Care Early Infant Diagnosis

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.

• Study Type: Interventional
• Enrollment (Actual): 9539
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Elizabeth Glaser Pediatric AIDS Foundation
• Zimbabwe
  • Harare, Zimbabwe
    • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: POC EID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing coverage for the 4-6 week indication	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	18 months
Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification	Date of sample collection to the date that results were given to care giver	18 months
Age of patient at test result notification for 4-6 week EID test indication	HEIs date of birth, date of sample collection and date of result notification to care giver	18 months
Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants	Date positive result received at facility to the date the result was communicated to mother and date of ART initiation	18 months
Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART	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	18 months
Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months	Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months	24 months

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: UNITAID
• Investigators: Principal Investigator: 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; Study Director: Jennifer Cohn, MD MPH, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: LMIC; HIV/AIDS; Point of Care; Early infant diagnosis; Health systems; Diagnostic tools
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: EG0170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No