HIVNCT02744404
Point of Care Early Infant Diagnosis Patient Impact Study
An observational study of HIV, run by Clinton Health Access Initiative Inc. at 7 sites in Malawi.
Trial summary
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- POC EID
- Type of treatment
- Medical device
- How many people
- 1,752 participants
- Where
- 7 sitesMalawi
- Study dates
- Sep 2015to Sep 2016
- Phase
- Observational
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will be mother-infant pairs from the general population attending the seven clinics for routine HIV-related, PMTCT and post-natal care services. Study subjects will be infants from mother-infant pairs presenting consecutively to the clinic for EID testing per the national EID guidelines during the study period.
Who may be able to join
- Younger than 12 months of age
- Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother
Who cannot join
- Older than 12 months of age
- Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
- Already initiated ART
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Malawi7 sites
Kamuzu Central Hospital
Lilongwe
Machinga District Hospital
Liwonde
Mzuzu Central Hospital
Mzuzu
Nsanama Health Center
Nsanama
Ntaja Health Center
Ntaja
Ntcheu District Hospital
Ntcheu
Migowi Health Center
Phalombe
About this study
Official title: Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.
- Conditions
- HIV
- Being tested
- POC EID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC EIDDevice
| Study group | Role | What they receive |
|---|---|---|
| POC EID | Point of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility. Receives: Device: POC EID | |
| Laboratory-based testing | Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART initiation retention
Proportion of HIV-positive infants initiated on anti-retroviral therapy
Measured: 6-9 months
Secondary outcomes (2)
Test turnaround time
Number of days from testing to result being received by the health care facility
Measured: 6-9 months
Tests received
Proportion of tests received by the health care facility
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malawi, UNICEF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744404
- Sponsor's protocol ID
- Malawi POC EID
- Status last verified
- Jul 2018
- First submitted
- 15 Apr 2016
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies
- ClinicalTrials.gov ID
- NCT02744404
- Acronym / sponsor ID
- Malawi POC EID
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,752 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Ministry of Health, Malawi, UNICEF
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POC EID | – | Device: POC EIDPoint of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility. |
| Laboratory-based testing | – | –Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will be mother-infant pairs from the general population attending the seven clinics for routine HIV-related, PMTCT and post-natal care services. Study subjects will be infants from mother-infant pairs presenting consecutively to the clinic for EID testing per the national EID guidelines during the study period.
Key inclusion criteria (2 listed)
- Younger than 12 months of age
- Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother
Key exclusion criteria (3 listed)
- Older than 12 months of age
- Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
- Already initiated ART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC EID | Device | POC EID |
Primary outcome
ART initiation retention
Time frame: 6-9 months
Proportion of HIV-positive infants initiated on anti-retroviral therapy
2 secondary outcomes
Test turnaround time
Time frame: 6-9 months
Tests received
Time frame: 6-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Clinton Health Access Initiative Inc. at 7 sites in Malawi.
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 2 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 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Malawi. 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?
ART initiation retention (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2018.