Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants

NCT03133728 | Completed

• 1 other identifier: UAB Neo 016
• Study Type: observational
• Target: 1,682
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

HIV Infections; Hiv

Keywords

EID HIV; Early Infant Diagnosis; Point of Care; Infant; HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 18 months

Secondary Outcomes (9)

• Age at first early infant HIV testing among HIV-exposed IYCs

  Baseline to 18 months

• 3-month survival for HIV-infected IYC receiving ART

  Baseline to 18 months

• 3-month retention in care for HIV-infected IYC receiving ART

  Baseline to 18 months

• Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect

  Baseline to 18 months

• Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model

  Baseline to 18 months

Study Arms (2)

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

Interventions

Alere Q Testing DIAGNOSTIC_TEST

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.

Also known as: Alere™ q HIV-1/2 Detect Test Point-of-Care Testing

Post-Intervention Group

Eligibility Criteria

• Age: 1 Minute - 17 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centre for Infectious Disease Research in Zambia: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (6)

George Primary Health Clinic

Lusaka, Zambia

Location

Kalingalinga Primary Health Clinic

Lusaka, Zambia

Location

Kamwala Primary Health Clinic

Lusaka, Zambia

Location

Makeni Primary Health Clinic

Lusaka, Zambia

Location

Matero Ref Primary Health Clinic

Lusaka, Zambia

Location

N'gombe Primary Health Clinic

Lusaka, Zambia

Location

Related Publications (1)

• 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.

  PMID: 39979018 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Albert Manasyan, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 28, 2017
• Study Start: May 30, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

ZA (6)