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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: Pediatric HIV Infection; Transmission, Perinatal Infection; HIV/AIDS; Infant Morbidity

Treatments: Diagnostic Test: Standard of Care Early Infant Diagnosis; Diagnostic Test: Point of Care Early Infant Diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03824067

EG0170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,539 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,539 participants in 2 patient groups

Standard of Care Early Infant Diagnosis

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Standard of Care Early Infant Diagnosis

Point of Care Early Infant Diagnosis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Point of Care Early Infant Diagnosis