POC HIV Testing and Early DTG Use for Infants

Phase 4

Active, not recruiting

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

• Registration Number: NCT05393193
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Study Start: 2022-07-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV-exposed neonates	Point-of-Care Cepheid Xpert HIV-1	Point-of-care HIV testing at birth
HIV-positive infants identified through birth HIV screening	DTG/ABC/3TC	Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg.

Primary Outcome Measures

Name	Time	Method
Median time to HIV diagnosis and treatment-dose ART	7 days	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.
The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART	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.
The proportion of children with successful DTG-based treatment through 96 weeks on ART	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.
The proportion of infants with grade 3 or 4 adverse events/hospitalization/death	96 weeks on ART	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.
Proportion of high-risk HIV-exposed infants identified and tested	within 72 hours of life	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.

Trial Locations

Locations (1)

Botswana Harvard HIV/AIDS Institute Partnership; 🇧🇼 Gaborone, Botswana