Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants (CDC Detect)

March 2, 2026 updated by: Albert Manasyan, MD, MPH, University of Alabama at Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • George Primary Health Clinic
      • Lusaka, Zambia
        • Kalingalinga Primary Health Clinic
      • Lusaka, Zambia
        • Kamwala Primary Health Clinic
      • Lusaka, Zambia
        • Makeni Primary Health Clinic
      • Lusaka, Zambia
        • Matero Ref Primary Health Clinic
      • Lusaka, Zambia
        • N'gombe Primary Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 minute to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HIV-exposed infants and young children (up to 17 months of age)

Description

Inclusion criteria include IYCs:

  1. 0 days (at birth) - 17 months of age;
  2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;

  3. The IYC must be born to mothers who:

    1. attended ≥1 ANC visits without HIV testing; or
    2. 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
    3. were documented as HIV-infected but never initiated ART; or
    4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or
    5. 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
    6. IYC not tested 6 weeks after cessation of breastfeeding.
  4. 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).

Exclusion criteria include IYCs:

  1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
  2. Already known to be HIV-infected / receiving ART.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Alere Q 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.
Other Names:
  • Alere™ q HIV-1/2 Detect Test Point-of-Care Testing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age at first early infant HIV testing among HIV-exposed IYCs
Time Frame: Baseline to 18 months
Average chronological ages of all IYCs when presenting for initial EID HIV testing.
Baseline to 18 months
3-month survival for HIV-infected IYC receiving ART
Time Frame: Baseline to 18 months
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.
Baseline to 18 months
3-month retention in care for HIV-infected IYC receiving ART
Time Frame: Baseline to 18 months
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.
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
Average time of ART initiation by IYCs who present for at initial HIV test following positive screening test within 17 months of age.
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
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).
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
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.
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
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.
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
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.
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
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.
Baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
Centre for Infectious Disease Research in Zambia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Albert Manasyan, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UAB Neo 016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available beginning 12 months following publication of the primary study results and will remain available for up to 5 years after publication.

IPD Sharing Access Criteria

Data will be available to qualified researchers who submit a scientifically sound research proposal consistent with the objectives of the original study and compliant with ethical standards.

Access will require:

  1. Approval by the study's Data Access Committee
  2. Evidence of ethics approval from the requestor's institution
  3. Execution of a Data Use Agreement
  4. Agreement not to attempt participant re-identification
  5. Compliance with applicable Zambian data protection regulations and institutional policies

Data will be shared through a secure data transfer platform or controlled-access repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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