HIVBABYNCT02545296
HIV Point-of-Care Test Evaluation in Infants
A study testing In-vitro Diagnostics in people with HIV, run by Michael Hoelscher at 1 site in Tanzania.
Trial summary
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania. Read more about this study
- Who is it for?
- Ages 1 minute to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- In-vitro Diagnostics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2015to Aug 2017
- 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 1 minute to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Voluntary and informed consent of the mother for her own study participation (if applicable).
- Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
- Mothers/legal guardians ≥18 years of age.
- Documented maternal HIV infection.
- Willingness to consent to HIV testing for the child and herself (if applicable).
- Willing to consent to active tracing including home tracing.
Who cannot join
- Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- Having delivered more than 48h ago
- Prisoners
- Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
- Stillbirths
- Infant requiring emergency care or born with severe malformation.
- If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g)
- Unlikely to comply with protocol as judged by the principal investigator or his designate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
Read the detailed description
This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.
Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.
The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
- Conditions
- HIV
- Being tested
- In-vitro Diagnostics
- Keywords
- In-vitro Diagnostics, paediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro DiagnosticsOther
Ex-vivo performed diagnostic blood based test.
| Study group | Role | What they receive |
|---|---|---|
| In-vitro Diagnostics | Other | All infants are recruited into the same arm. Receives: Other: In-vitro Diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of PoC HIV test
Specificity of the PoC HIV test
Measured: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Sensitivity of PoC HIV test
Sensitivity of the PoC HIV test
Measured: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionAug 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Hoelscher, Prof Dr, Study director, Medical Centre of the University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545296
- Sponsor's protocol ID
- LMU-IMPH-BABY-01
- Acronym
- BABY
- Status last verified
- Mar 2018
- First submitted
- 8 Jul 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sabi I, Mahiga H, Mgaya J, Geisenberger O, Kastner S, Olomi W, Saathoff E, Njovu L, Lueer C, France J, Maboko L, Ntinginya NE, Hoelscher M, Kroidl A. Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus-exposed Neonates in Tanzania. Clin Infect Dis. 2019 Feb 1;68(4):615-622. doi: 10.1093/cid/ciy538.
PubMed 29961841
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania
- ClinicalTrials.gov ID
- NCT02545296
- Acronym / sponsor ID
- BABY / LMU-IMPH-BABY-01
- Conditions
- HIV
- Keywords
- In-vitro Diagnostics, paediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Collaborators
- German Center for Infection Research
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Sep 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.
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
Detailed description
This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.
Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.
The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-vitro Diagnostics | Other | Other: In-vitro DiagnosticsAll infants are recruited into the same arm. |
Who may qualify
- Ages
- 1 minute to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Voluntary and informed consent of the mother for her own study participation (if applicable).
- Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
- Mothers/legal guardians ≥18 years of age.
- Documented maternal HIV infection.
- Willingness to consent to HIV testing for the child and herself (if applicable).
Key exclusion criteria (8 listed)
- Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- Having delivered more than 48h ago
- Prisoners
- Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
- Stillbirths
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 |
|---|---|---|
| In-vitro DiagnosticsEx-vivo performed diagnostic blood based test. | Other | In-vitro Diagnostics |
Primary outcome
Specificity of PoC HIV test
Time frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Specificity of the PoC HIV test
Sensitivity of PoC HIV test
Time frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Sensitivity of the PoC HIV test
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 7 Mar 2018.
- Derived from this study: PubMed 29961841Sabi I, Mahiga H, Mgaya J, Geisenberger O, Kastner S, Olomi W, Saathoff E, Njovu L, Lueer C, France J, Maboko L, Ntinginya NE, Hoelscher M, Kroidl A. Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus-exposed Neonates in Tanzania. Clin Infect Dis. 2019 Feb 1;68(4):615-622. doi: 10.1093/cid/ciy538.
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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.
Michael Hoelscher, Prof Dr study director
Medical Centre of the University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-vitro Diagnostics in people with HIV, run by Michael Hoelscher at 1 site in Tanzania.
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 6 inclusion and 8 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Specificity of PoC HIV test (time frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID). 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 NCT02545296, 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 7 Mar 2018.