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HIV/AIDSPOC-EIDNCT03824067

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

A study testing Point of Care Early Infant Diagnosis in people with HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Point of Care Early Infant Diagnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,539 participants
Where
2 sitesin 2 countries
Study dates
1 Aug 2017to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Kenya1 site

  • Elizabeth Glaser Pediatric AIDS Foundation

    Nairobi

Other trials in Kenya

Zimbabwe1 site

  • Elizabeth Glaser Pediatric AIDS Foundation

    Harare

Other trials in Zimbabwe

About this study

Official 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

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.

Read the 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.

Being tested
Point of Care Early Infant Diagnosis, Standard of Care Early Infant Diagnosis
Keywords
HIV/AIDS, Point of Care, Early infant diagnosis, Health systems, Diagnostic tools, LMIC
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Point of Care Early Infant DiagnosisDiagnostic test

    Also called POC EID

    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.

  • Standard of Care Early Infant DiagnosisDiagnostic test

    Also called SOC EID

    Conventional laboratory based EID testing

Study groups in NCT03824067
Study groupRoleWhat they receive
Standard of Care Early Infant DiagnosisActive comparatorConventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID
Receives: Diagnostic Test: Standard of Care Early Infant Diagnosis
Point of Care Early Infant DiagnosisExperimentalThe 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.
Receives: Diagnostic Test: Point of Care Early Infant Diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (6)

  1. 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

    Measured: 18 months

  2. 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

    Measured: 18 months

  3. 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

    Measured: 18 months

  4. 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

    Measured: 18 months

  5. 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

    Measured: 18 months

  6. 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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start1 Aug 2017
  3. Primary completion30 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
9,539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824067
Sponsor's protocol ID
EG0170
Acronym
POC-EID
Status last verified
Dec 2019
First submitted
25 Jan 2019
Last updated
5 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Point of Care Early Infant Diagnosis in people with HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03824067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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