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POC HIV Testing and Early DTG Use for Infants

NCT05393193 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Point-of-Care Cepheid Xpert HIV-1

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.

DRUG

DTG/ABC/3TC

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.

Sponsors & Collaborators

  • Botswana Harvard AIDS Institute Partnership

    collaborator OTHER

  • Ragon Institute of MGH, MIT and Harvard

    collaborator OTHER

  • Botswana Ministry of Health

    collaborator OTHER_GOV

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Roger L Shapiro, MD, MPH · Harvard School of Public Health (HSPH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2026-05-31
Completion
2026-08-31

Countries

  • Botswana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393193 on ClinicalTrials.gov