POC HIV Testing and Early DTG Use for Infants

President and Fellows of Harvard College

Status and phase: Active, not recruiting; Phase 4

Conditions: HIV

Treatments: Diagnostic Test: Point-of-Care Cepheid Xpert HIV-1; Drug: DTG/ABC/3TC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05393193

155BHP

P01HD107670 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for point-of-care infant HIV testing:

1. Mother 18 years of age or older
2. Mother willing and able to provide verbal consent for infant testing
3. Infant birth weight ≥1.5kg
4. 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)

Exclusion criteria for point-of-care infant HIV testing:

1. Medical condition making it unlikely that the infant will survive to 24 months

Inclusion criteria for infant longitudinal treatment cohort:

1. Mother 18 years of age or older
2. Mother willing and able to provide written informed consent for study participation for herself and her infant
3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
4. Infant eligible for ART treatment in accordance with the Botswana government program
5. Infant birth weight ≥1.5 kg

Exclusion criteria for infant longitudinal treatment cohort:

1. Medical condition making it unlikely that the infant will survive to 24 months
2. Infant unable to start treatment-dose ART < 168 hours of age
3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

HIV-exposed neonates

Other group

Description:

Point-of-care HIV testing at birth

Treatment:

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

HIV-positive infants identified through birth HIV screening

Other group

Description:

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

Treatment:

Drug: DTG/ABC/3TC