POC HIV Testing and Early DTG Use for Infants

NCT05393193 | Active Not Recruiting Phase 4

• 2 other identifiers: 155BHPP01HD107670
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.

Conditions

HIV

Outcome Measures

Primary Outcomes (5)

• Proportion of high-risk HIV-exposed infants identified and tested

  Analysis will largely be descriptive, highlighting the proportion of high-risk infants identified and tested at each facility. Proportions will be determined by populating actual numbers approached and screened matched against exact denominators obtained from surveillance data.

  within 72 hours of life

• Median time to HIV diagnosis and treatment-dose ART

  We will describe the proportion of high-risk infants found to be HIV positive per risk category and compare this to findings from another cohort study of early-treated children. Average time to HIV diagnosis and treatment initiation will also be described.

  7 days

• The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART

  We will compare time to viral suppression and the proportion with complete HIV-1 RNA suppression (\<40 copies/mL) at 12 weeks from ART start between infants on early DTG with another cohort of children on early LPV/r.

  12 weeks on ART

• The proportion of children with successful DTG-based treatment through 96 weeks on ART

  We will compare the proportion with complete HIV-1 RNA suppression and no need for treatment modification at all visits through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.

  96 weeks on ART

• The proportion of infants with grade 3 or 4 adverse events/hospitalization/death

  We will compare the proportion with grade 3 or 4 adverse events through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.

  96 weeks on ART

Study Arms (2)

HIV-exposed neonates

OTHER

Point-of-care HIV testing at birth

Diagnostic Test: Point-of-Care Cepheid Xpert HIV-1

HIV-positive infants identified through birth HIV screening

OTHER

Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg.

Drug: DTG/ABC/3TC

Interventions

Point-of-Care Cepheid Xpert HIV-1 DIAGNOSTIC_TEST

Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.

HIV-exposed neonates

DTG/ABC/3TC DRUG

Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.

HIV-positive infants identified through birth HIV screening

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother 18 years of age or older
• Mother willing and able to provide verbal consent for infant testing
• Infant birth weight ≥1.5kg
• Presence of any of the following risk factors:
• \<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time \>24 weeks gestation in pregnancy; CD4 cell count known to be \<350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)

You may not qualify if:

• \) Medical condition making it unlikely that the infant will survive to 24 months
• Mother 18 years of age or older
• Mother willing and able to provide written informed consent for study participation for herself and her infant
• Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
• Infant eligible for ART treatment in accordance with the Botswana government program
• Infant birth weight ≥1.5 kg
• Medical condition making it unlikely that the infant will survive to 24 months
• Infant unable to start treatment-dose ART \< 168 hours of age
• Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Botswana Harvard AIDS Institute Partnership: collaborator
• Ragon Institute of MGH, MIT and Harvard: collaborator
• Botswana Ministry of Health: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Botswana Harvard Health Partnership

Gaborone, Botswana

Location

Study Officials

• Roger L Shapiro, MD, MPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Immunology and Infectious Diseases

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: July 4, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

BO (1)