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Completed

NCT Number: NCT03824067

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infant Morbidity Infections Lentivirus Infections Pediatric HIV Infection RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Transmission, Perinatal Infection Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of Care Early Infant Diagnosis

Diagnostic 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.

Other names: POC EID

Standard of Care Early Infant Diagnosis

Diagnostic Test

Conventional laboratory based EID testing

Other names: SOC EID

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • UNITAID

Registry information

Official study 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

Acronym: POC-EID

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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