HIV InfectionsCDC DetectNCT03133728
Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants
An observational study of HIV Infections and Hiv, run by University of Alabama at Birmingham at 6 sites in Zambia.
Trial summary
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. Read more about this study
- Who is it for?
- Ages 1 minute to 17 months
- Conditions the study is for
- HIV Infections, Hiv
- What is being tested?
- Alere Q Testing
- How many people
- 1,682 participants
- Where
- 6 sitesZambia
- Study dates
- 30 May 2019to 29 Sep 2020
- 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 1 minute to 17 months
- All sexes
- No healthy volunteers
- Child
Study population: HIV-exposed infants and young children (up to 17 months of age)
Who may be able to join
- 0 days (at birth) - 17 months of age;
- Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;
- The IYC must be born to mothers who:
- attended ≥1 ANC visits without HIV testing; or
- delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or
- were documented as HIV-infected but never initiated ART; or
Show all 10Show fewer
- disengaged from HIV care after ART initiation/have not returned for ARV refills; or
- have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or
- IYC not tested 6 weeks after cessation of breastfeeding.
- With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).
Who cannot join
- With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
- Already known to be HIV-infected / receiving ART.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Zambia6 sites
George Primary Health Clinic
Lusaka
Kalingalinga Primary Health Clinic
Lusaka
Kamwala Primary Health Clinic
Lusaka
Makeni Primary Health Clinic
Lusaka
Matero Ref Primary Health Clinic
Lusaka
N'gombe Primary Health Clinic
Lusaka
About this study
Official title: To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.
Read the detailed description
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children through a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.
- Conditions
- HIV Infections, Hiv
- Being tested
- Alere Q Testing
- Keywords
- EID HIV, Early Infant Diagnosis, Point of Care, Infant, HIV
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alere Q TestingDiagnostic test
Also called Alere™ q HIV-1/2 Detect Test Point-of-Care Testing
Infants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention Group | The Investigators will visit each of the selected 3 clusters (i.e. 6 primary health clinics) to construct a retrospective cohort of high-risk HIV-infected women who entered the national PMTCT program and received the SOC between June 1, 2017 and May 31, 2018. Using existing data through the electronic health record information (SmartCare and LIMS), the investigators will gather individual-level retrospective data on high-risk Mother-Infant Pairs (MIPs) from PMTCT enrolment through the child's ART enrolment, initiation, and retention rate at 3 months. | |
| Post-Intervention Group | Study Research Assistants (RA) will review routine patient files and registers, augmented by existing electronic health record information, to identify a new cohort of high-risk Mother-Infant Pairs (MIPs) at each study site between the dates of June 1, 2019 and May 31, 2020. The outreach team will include, at a minimum, the study RA, a study peer, and an HIV counselor from the health facility, who will carry the Alere™ q HIV-1/2 Detect with them. When the outreach team contacts a high-risk MIP at community level, the team will approach the MIP for study screening, consent, and enrolment procedures. Study staff will ask the parent/guardian if the parent/guardian would like the IYC to be tested at their home, at a community health post, or other private space in the community. The IYC will be tested using both the Alere™ q HIV-1/2 Detect platform and a reflex DBS PCR test to evaluate performance of the POC platform in a mobile setting against the gold standard. Receives: Diagnostic Test: Alere Q Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC)
Number of IYCs who were initiated on ARVs following a positive HIV test divided by the number of IYCs who tested positive for HIV.
Measured: Baseline to 18 months
Secondary outcomes (9)
Age at first early infant HIV testing among HIV-exposed IYCs
Average chronological ages of all IYCs when presenting for initial EID HIV testing.
Measured: Baseline to 18 months
3-month survival for HIV-infected IYC receiving ART
Number of HIV-infected IYCs receiving ART who presented alive at 3 month visit divided by the total number of HIV-infected IYCs enrolled into ART.
Measured: Baseline to 18 months
3-month retention in care for HIV-infected IYC receiving ART
Number of HIV-infected IYCs receiving ART who were retained in care at 6 month visit divided by the total number of HIV-infected IYCs enrolled in ART.
Measured: Baseline to 18 months
Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect
Average time of ART initiation by IYCs who present for at initial HIV test following positive screening test within 17 months of age.
Measured: Baseline to 18 months
Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
A pre-defined set of questions will be asked to all the parent/guardians to evaluate their knowledge regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in in-depth interviews (IDIs).
Measured: Baseline to 18 months
Describe attitudes of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
A pre-defined set of questions will be asked to all the parent/guardians to evaluate their attitudes regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in IDIs.
Measured: Baseline to 18 months
Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
A pre-defined set of questions will be asked to all the parent/guardians to evaluate their knowledge regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in IDIs.
Measured: Baseline to 18 months
Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
A pre-defined set of questions will be asked to all the healthcare providers to characterize the feasibility of using the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 healthcare providers who have used the platform to participate in IDIs.
Measured: Baseline to 18 months
Characterize the acceptability of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
A pre-defined set of questions will be asked to all the healthcare providers to characterize the acceptability of using the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 healthcare providers who have used the platform to participate in IDIs.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start30 May 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
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 InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 1,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Albert Manasyan, MD, MPH, University of Alabama at Birmingham
- Investigators
- Albert Manasyan, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133728
- Sponsor's protocol ID
- UAB Neo 016
- Acronym
- CDC Detect
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2017
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary study findings, including maternal demographic and clinical characteristics, maternal HIV status, point-of-care HIV test results for newborns, reference laboratory test results (where applicable), timing of testing, and relevant neonatal clinical outcomes. All direct identifiers will be removed, and indirect identifiers will be coded to protect participant confidentiality.
Publications
Manasyan A, Tembo T, Dale H, Pry JM, Itoh M, Williamson D, Kapesa H, Derado J, Beard RS, Iyer S, Gass S, Mwila A, Herce ME. Differentiated community-based point-of-care early infant diagnosis to improve HIV diagnosis and ART initiation among infants and young children in Zambia: a quasi-experimental cohort study. BMJ Glob Health. 2025 Feb 20;10(2):e015759. doi: 10.1136/bmjgh-2024-015759.
PubMed 39979018
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis
- ClinicalTrials.gov ID
- NCT03133728
- Acronym / sponsor ID
- CDC Detect / UAB Neo 016
- Conditions
- HIV Infections, Hiv
- Keywords
- EID HIV, Early Infant Diagnosis, Point of Care, Infant, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,682 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention
- Study start
- 30 May 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 28 Apr 2017 (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.
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.
Detailed description
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children through a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Group | – | –The Investigators will visit each of the selected 3 clusters (i.e. 6 primary health clinics) to construct a retrospective cohort of high-risk HIV-infected women who entered the national PMTCT program and received the SOC between June 1, 2017 and May 31, 2018. Using existing data through the electronic health record information (SmartCare and LIMS), the investigators will gather individual-level retrospective data on high-risk Mother-Infant Pairs (MIPs) from PMTCT enrolment through the child's ART enrolment, initiation, and retention rate at 3 months. |
| Post-Intervention Group | – | Diagnostic Test: Alere Q TestingStudy Research Assistants (RA) will review routine patient files and registers, augmented by existing electronic health record information, to identify a new cohort of high-risk Mother-Infant Pairs (MIPs) at each study site between the dates of June 1, 2019 and May 31, 2020. The outreach team will include, at a minimum, the study RA, a study peer, and an HIV counselor from the health facility, who will carry the Alere™ q HIV-1/2 Detect with them. When the outreach team contacts a high-risk MIP at community level, the team will approach the MIP for study screening, consent, and enrolment procedures. Study staff will ask the parent/guardian if the parent/guardian would like the IYC to be tested at their home, at a community health post, or other private space in the community. The IYC will be tested using both the Alere™ q HIV-1/2 Detect platform and a reflex DBS PCR test to evaluate performance of the POC platform in a mobile setting against the gold standard. |
Who may qualify
- Ages
- 1 minute to 17 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV-exposed infants and young children (up to 17 months of age)
Key inclusion criteria (10 listed)
- 0 days (at birth) - 17 months of age;
- Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;
- The IYC must be born to mothers who:
- With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).
Key exclusion criteria (2 listed)
- With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
- Already known to be HIV-infected / receiving 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 |
|---|---|---|
| Alere Q TestingAlso: Alere™ q HIV-1/2 Detect Test Point-of-Care TestingInfants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation. | Diagnostic test | Post-Intervention Group |
Primary outcome
Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC)
Time frame: Baseline to 18 months
Number of IYCs who were initiated on ARVs following a positive HIV test divided by the number of IYCs who tested positive for HIV.
9 secondary outcomes
Age at first early infant HIV testing among HIV-exposed IYCs
Time frame: Baseline to 18 months
3-month survival for HIV-infected IYC receiving ART
Time frame: Baseline to 18 months
3-month retention in care for HIV-infected IYC receiving ART
Time frame: Baseline to 18 months
Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect
Time frame: Baseline to 18 months
Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
Time frame: Baseline to 18 months
Describe attitudes of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
Time frame: Baseline to 18 months
Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
Time frame: Baseline to 18 months
Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
Time frame: Baseline to 18 months
Characterize the acceptability of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
Time frame: Baseline to 18 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 4 Mar 2026.
- Derived from this study: PubMed 39979018Manasyan A, Tembo T, Dale H, Pry JM, Itoh M, Williamson D, Kapesa H, Derado J, Beard RS, Iyer S, Gass S, Mwila A, Herce ME. Differentiated community-based point-of-care early infant diagnosis to improve HIV diagnosis and ART initiation among infants and young children in Zambia: a quasi-experimental cohort study. BMJ Glob Health. 2025 Feb 20;10(2):e015759. doi: 10.1136/bmjgh-2024-015759.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary study findings, including maternal demographic and clinical characteristics, maternal HIV status, point-of-care HIV test results for newborns, reference laboratory test results (where applicable), timing of testing, and relevant neonatal clinical outcomes. All direct identifiers will be removed, and indirect identifiers will be coded to protect participant confidentiality.
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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.
Albert Manasyan, MD principal investigator
University of Alabama at Birmingham
6 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 Infections and Hiv, run by University of Alabama at Birmingham at 6 sites in Zambia.
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 10 inclusion and 2 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Zambia. 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?
Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC) (time frame: Baseline to 18 months). 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 NCT03133728, 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 4 Mar 2026.