HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)LIFENCT04032522
Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)
An observational study of HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC), run by Michael Hoelscher at 2 sites in 2 countries.
Trial summary
This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, that can provide neonatal HIV test results within 2 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)
- What is being tested?
- point-of care (PoC) neonatal HIV early infant diagnosis (EID)
- How many people
- 6,602 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Oct 2019to 1 Jan 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected pregnant women and their exposed infants will be recruited at maternity clinics in Mozambique and Tanzania. Assuming a 4% MTCT rate by week 6 and a difference of combined HIV-infected infant endpoints of 14% (Arm A) versus 30% (Arm B) the study target is to enrol at least 224 HIV infected infants (112 per arm) from both countries into the follow-up phase resulting in an overall recruitment number of 6000 mother-child pairs (3000 per arm), including an assumed 5% loss to follow-up. Furthermore, we will enrol 400 HIV-exposed infants from both countries after week 12 into a long-term follow-up phase to investigate MTCT rates and associated MTCT risks until the end of the study period after cessation of breastfeeding.
Who may be able to join
- Voluntary and informed consent of the mother for her own study participation
- 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.
- Willingness 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 72h (3 days) ago
- Prisoners
- Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion
- Stillbirths
- Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) 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
2 sites in 2 countries.
2 sites in 2 countries
Mozambique1 site
Centro de Investigacao Operacional da Beira (CIOB)
Beira, Sofala
About this study
Official title: Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID - Long Term Impact on inFant hEalth: a Feasibility Study of point-of Care Testing at Birth Versus at 6 Weeks of Age, on the Uptake of ART and Infant Prophylaxis, and on Rates of Infant Survival, Morbidity and Retention in Care
This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, that can provide neonatal HIV test results within 2 hours. We will evaluate if HIV testing at birth followed by immediate neonatal HIV treatment initiation will lead to lesser infant's sickness, HIV progression or even death as compared to the current standard procedure which is infant HIV testing at week 6 after delivery. This will be associated with a cost-effectiveness analysis in order to guide national HIV programs for their guidelines. The study will further evaluate if point-of care viral load testing in mothers at birth will identify high-risk scenarios for HIV transmission from the mother to her child. This should lead to enhanced prophylactic treatments in HIV-exposed infants and we hypothesize that PoC VL monitoring at birth leads to lower transmission rates. The study will be performed at 28 maternity health facilities in Tanzania and Mozambique, half of them will be randomized to provide birth HIV PoC infant and maternal viral load testing, the other half will provide the current standard of care (infant HIV testing at week 6, no PoC VL monitoring at birth for the mother). The study is conducted in public health settings, and some study objectives also focus on how successful modern HIV treatments can be provided to infants, if HIV testing and treatment procedures are feasible for nurses and midwives, and if these procedures can be carried out in a timely manner. This study also includes a basic research component that will investigate how HIV spreads in the body of HIV-infected infants, and if early infant HIV diagnosis and treatment can reduce the spread in cells of HIV-infected individuals.
- Being tested
- point-of care (PoC) neonatal HIV early infant diagnosis (EID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of care (PoC) neonatal HIV early infant diagnosis (EID)Other
clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (A) | Half of the health facilities will implement the intervention package. All mothers will be tested using PoC-VL at delivery and all HIV-exposed infants will be offered PoC-EID at birth and week 4-8. Newborns found to be HIV-positive will be offered immediate ART. Neonatal ART initiation will be supported at birth by trained nurses/midwives, and approved and supervised by local doctors from the affiliated HIV CTC. Following ART initiation infants will be referred for consolidated ART management to their paediatric HIV clinic following local procedures. Newborns testing HIV-negative will be offered postnatal prophylaxis (PNP) or enhanced postnatal prophylaxis (ePNP), depending on clinical risk factors, the maternal VL and country guidelines. Mothers with HIV-RNA >1000 copies/mL will receive immediate referral information for ART initiation if not on ART or enhanced ART counselling, with follow up virologic testing and switch of ART regimen as applicable at their local HIV clinic. Receives: Other: point-of care (PoC) neonatal HIV early infant diagnosis (EID) | |
| Control Arm (B) | The other half of the health facilities will implement the standard of care (SoC). Enrolled mothers will not receive immediate PoC VL at delivery, but infants deemed to be at high risk using clinical criteria (e.g. no or late initiation of maternal ART) will be offered ePNP. EID testing will follow the national algorithm with testing at 4-8 weeks, followed by referral for immediate ART initiation for all HIV-infected infants. As PoC EID testing is expected to be nationally implemented on a programme level we will facilitate the availability of PoC testing at these sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical impact of a PoC-EID
The primary objective is to establish the clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC) on the primary and secondary endpoints. Combined clinical outcomes will include mortality, morbidity (WHO Stage 2 or above disease, severe infant medical conditions), hospitalization, toxicity (Grade 3 or above laboratory abnormality), poor antiretroviral treatment response (confirmed virological failure, treatment termination or prolonged interruption), or loss to follow up of HIVinfected infants.
Measured: Proportion of combined clinical endpoints in HIV-infected infants at months 18 between arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start23 Oct 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
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 HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 6,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania, University of Lisbon Instituto Universitário Egas Moniz (IUEM) Lisbon, Portugal, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Arne Kroidl, Dr. med, Study chair, Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU MunichIlesh Jani, Dr., Ph.D., Principal investigator, Instituto Nacional de Saúde, MozambiqueIssa Sabi, Dr., Principal investigator, NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032522
- Sponsor's protocol ID
- LMU-IMPH-LIFE
- Acronym
- LIFE
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2019
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jani IV, Sabi I, Elsbernd K, Meggi B, Mahumane A, Lwilla AF, Pereira K, Boniface S, Edom R, Lequechane J, Chale F, Chiwerengo N, Ntinginya NE, Mudenyanga C, Mueller M, Rauscher M, Hoelscher M, Taveira N, Buck WC, Kroidl A; LIFE Study Consortium. Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania. Clin Infect Dis. 2025 Jun 4;80(5):1114-1124. doi: 10.1093/cid/ciae530.
PubMed 39514367
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID - Long Term Impact on inFant hEalth: a Feasibility Study of point-of Care Testing at Birth Versus at 6 Weeks of Age, on the Uptake of ART and Infant Prophylaxis, and on Rates of Infant Survival, Morbidity and Retention in Care
- ClinicalTrials.gov ID
- NCT04032522
- Acronym / sponsor ID
- LIFE / LMU-IMPH-LIFE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,602 participants (actual)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania, University of Lisbon Instituto Universitário Egas Moniz (IUEM) Lisbon, Portugal, Clinton Health Access Initiative Inc.
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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.
This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, that can provide neonatal HIV test results within 2 hours. We will evaluate if HIV testing at birth followed by immediate neonatal HIV treatment initiation will lead to lesser infant's sickness, HIV progression or even death as compared to the current standard procedure which is infant HIV testing at week 6 after delivery. This will be associated with a cost-effectiveness analysis in order to guide national HIV programs for their guidelines. The study will further evaluate if point-of care viral load testing in mothers at birth will identify high-risk scenarios for HIV transmission from the mother to her child. This should lead to enhanced prophylactic treatments in HIV-exposed infants and we hypothesize that PoC VL monitoring at birth leads to lower transmission rates. The study will be performed at 28 maternity health facilities in Tanzania and Mozambique, half of them will be randomized to provide birth HIV PoC infant and maternal viral load testing, the other half will provide the current standard of care (infant HIV testing at week 6, no PoC VL monitoring at birth for the mother). The study is conducted in public health settings, and some study objectives also focus on how successful modern HIV treatments can be provided to infants, if HIV testing and treatment procedures are feasible for nurses and midwives, and if these procedures can be carried out in a timely manner. This study also includes a basic research component that will investigate how HIV spreads in the body of HIV-infected infants, and if early infant HIV diagnosis and treatment can reduce the spread in cells of HIV-infected individuals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (A) | – | Other: point-of care (PoC) neonatal HIV early infant diagnosis (EID)Half of the health facilities will implement the intervention package. All mothers will be tested using PoC-VL at delivery and all HIV-exposed infants will be offered PoC-EID at birth and week 4-8. Newborns found to be HIV-positive will be offered immediate ART. Neonatal ART initiation will be supported at birth by trained nurses/midwives, and approved and supervised by local doctors from the affiliated HIV CTC. Following ART initiation infants will be referred for consolidated ART management to their paediatric HIV clinic following local procedures. Newborns testing HIV-negative will be offered postnatal prophylaxis (PNP) or enhanced postnatal prophylaxis (ePNP), depending on clinical risk factors, the maternal VL and country guidelines. Mothers with HIV-RNA >1000 copies/mL will receive immediate referral information for ART initiation if not on ART or enhanced ART counselling, with follow up virologic testing and switch of ART regimen as applicable at their local HIV clinic. |
| Control Arm (B) | – | –The other half of the health facilities will implement the standard of care (SoC). Enrolled mothers will not receive immediate PoC VL at delivery, but infants deemed to be at high risk using clinical criteria (e.g. no or late initiation of maternal ART) will be offered ePNP. EID testing will follow the national algorithm with testing at 4-8 weeks, followed by referral for immediate ART initiation for all HIV-infected infants. As PoC EID testing is expected to be nationally implemented on a programme level we will facilitate the availability of PoC testing at these sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected pregnant women and their exposed infants will be recruited at maternity clinics in Mozambique and Tanzania. Assuming a 4% MTCT rate by week 6 and a difference of combined HIV-infected infant endpoints of 14% (Arm A) versus 30% (Arm B) the study target is to enrol at least 224 HIV infected infants (112 per arm) from both countries into the follow-up phase resulting in an overall recruitment number of 6000 mother-child pairs (3000 per arm), including an assumed 5% loss to follow-up. Furthermore, we will enrol 400 HIV-exposed infants from both countries after week 12 into a long-term follow-up phase to investigate MTCT rates and associated MTCT risks until the end of the study period after cessation of breastfeeding.
Key inclusion criteria (6 listed)
- Voluntary and informed consent of the mother for her own study participation
- 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.
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 72h (3 days) 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 |
|---|---|---|
| point-of care (PoC) neonatal HIV early infant diagnosis (EID)clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC) | Other | Intervention Arm (A) |
Primary outcome
clinical impact of a PoC-EID
Time frame: Proportion of combined clinical endpoints in HIV-infected infants at months 18 between arms
The primary objective is to establish the clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC) on the primary and secondary endpoints. Combined clinical outcomes will include mortality, morbidity (WHO Stage 2 or above disease, severe infant medical conditions), hospitalization, toxicity (Grade 3 or above laboratory abnormality), poor antiretroviral treatment response (confirmed virological failure, treatment termination or prolonged interruption), or loss to follow up of HIVinfected infants.
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 22 Aug 2024.
- Derived from this study: PubMed 39514367Jani IV, Sabi I, Elsbernd K, Meggi B, Mahumane A, Lwilla AF, Pereira K, Boniface S, Edom R, Lequechane J, Chale F, Chiwerengo N, Ntinginya NE, Mudenyanga C, Mueller M, Rauscher M, Hoelscher M, Taveira N, Buck WC, Kroidl A; LIFE Study Consortium. Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania. Clin Infect Dis. 2025 Jun 4;80(5):1114-1124. doi: 10.1093/cid/ciae530.
- Individual participant dataSharing planned: Undecided
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.
Arne Kroidl, Dr. med study chair
Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich
Ilesh Jani, Dr., Ph.D. principal investigator
Instituto Nacional de Saúde, Mozambique
Issa Sabi, Dr. principal investigator
NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC), run by Michael Hoelscher 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 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 22 Aug 2024. 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 Mozambique, 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?
clinical impact of a PoC-EID (time frame: Proportion of combined clinical endpoints in HIV-infected infants at months 18 between arms). 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 NCT04032522, 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 22 Aug 2024.