HIVNCT02634450
Early Infant Diagnosis Point of Care Pilot
A study testing Alere q in people with HIV, run by Instituto Nacional de Saúde, Mozambique at 8 sites in Mozambique.
Trial summary
In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close access to laboratories. Read more about this study
- Who is it for?
- Ages 4 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Alere q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 8 sitesMozambique
- Study dates
- Sep 2015to 30 Sep 2016
- 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 4 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born to HIV positive mother
- From 4 weeks to 18 months of age
- Came to CCR consultation for Early Infant Diagnosis
Who cannot join
- With a valid positive test by other center
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Mozambique8 sites
Centro de Saude de Manga Loforte
Beira, Sofala
Centro de Saude de Ponta Gea
Beira, Sofala
Centro de Saude Munhava
Beira, Sofala
Centro de Saude NHACONJO
Beira, Sofala
Centro de Saude de Machava II
Maputo
Centro de Saude Matola Gare
Maputo
Centro de Saúde de Khongolote
Maputo
Centro de Saude Moamba
Moamba, Maputo Province
About this study
Official title: Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close 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 now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study. No consent will be asked to the parents or guardians. A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites. All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.
- Conditions
- HIV
- Being tested
- Alere q
- Keywords
- HIV, Diagnostic, children
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alere qDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Current practice of Early Infant Diagnosis in Mozambique: using conventional system of collecting blood on Dried Blood Spot and sending it to central laboratory for PCR processing and receiving result by SMS printer. |
| Intervention | Active comparator | Point Of Care Device (Alere q) is used for Early Infant Diagnosis, with the sample collected and processed in the consultation room with the device Receives: Device: Alere q |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection
Measured: up to 6 months
the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up.
Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days.
Measured: 3 months after treatment initiation
Secondary outcomes (4)
The median age at time of results received by patient
Measured: Up to 6 months
The median number of days between specimen collection and results received by patient
Measured: Up to 6 months
The median age at time of antiretroviral treatment initiation
Measured: Up to 6 months
The median number of days between specimen collection and initiation of antiretroviral treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startSep 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Saúde, Mozambique
- Sponsor type
- Other government
- Collaborators
- Clinton Health Access Initiative Inc., UNICEF, UNITAID
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634450
- Sponsor's protocol ID
- POC EID PILOT
- Status last verified
- Jul 2017
- First submitted
- 5 Dec 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jani IV, Meggi B, Loquiha O, Tobaiwa O, Mudenyanga C, Zitha A, Mutsaka D, Mabunda N, Vubil A, Bollinger T, Vojnov L, Peter TF. Effect of point-of-care early infant diagnosis on antiretroviral therapy initiation and retention of patients. AIDS. 2018 Jul 17;32(11):1453-1463. doi: 10.1097/QAD.0000000000001846.
PubMed 29746301
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT02634450
- Acronym / sponsor ID
- POC EID PILOT
- Conditions
- HIV
- Keywords
- HIV, Diagnostic, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Instituto Nacional de Saúde, MozambiqueOther government
- Collaborators
- Clinton Health Access Initiative Inc., UNICEF, UNITAID
- Study start
- Sep 2015
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 18 Dec 2015 (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 Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close 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 now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study. No consent will be asked to the parents or guardians. A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites. All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Current practice of Early Infant Diagnosis in Mozambique: using conventional system of collecting blood on Dried Blood Spot and sending it to central laboratory for PCR processing and receiving result by SMS printer. |
| Intervention | Active comparator | Device: Alere qPoint Of Care Device (Alere q) is used for Early Infant Diagnosis, with the sample collected and processed in the consultation room with the device |
Who may qualify
- Ages
- 4 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born to HIV positive mother
- From 4 weeks to 18 months of age
- Came to CCR consultation for Early Infant Diagnosis
Key exclusion criteria (1 listed)
- With a valid positive test by other center
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 |
|---|---|---|
| Alere q | Device | Intervention |
Primary outcome
The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection
Time frame: up to 6 months
the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up.
Time frame: 3 months after treatment initiation
Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days.
4 secondary outcomes
The median age at time of results received by patient
Time frame: Up to 6 months
The median number of days between specimen collection and results received by patient
Time frame: Up to 6 months
The median age at time of antiretroviral treatment initiation
Time frame: Up to 6 months
The median number of days between specimen collection and initiation of antiretroviral treatment.
Time frame: Up to 6 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 26 Jul 2017.
- Derived from this study: PubMed 29746301Jani IV, Meggi B, Loquiha O, Tobaiwa O, Mudenyanga C, Zitha A, Mutsaka D, Mabunda N, Vubil A, Bollinger T, Vojnov L, Peter TF. Effect of point-of-care early infant diagnosis on antiretroviral therapy initiation and retention of patients. AIDS. 2018 Jul 17;32(11):1453-1463. doi: 10.1097/QAD.0000000000001846.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alere q in people with HIV, run by Instituto Nacional de Saúde, Mozambique at 8 sites in Mozambique.
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 3 inclusion and 1 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Mozambique. 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?
The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 NCT02634450, which also lists 1 linked publication.
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 26 Jul 2017.