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POC HIV Testing and Early DTG Use for Infants | Clinical Trials | Clareo Health

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POC HIV Testing and Early DTG Use for Infants

Point-of-Care HIV Testing and Early Dolutegravir Use for Infants

NCT05393193•Harvard School of Public Health (HSPH)

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
•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

•1\) Medical condition making it unlikely that the infant will survive to 24 months
•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

Locations (1)

Botswana Harvard Health Partnership

Gaborone, Botswana

Key Dates

Start Date

July 4, 2022

Primary Completion Date

May 31, 2026

Completion Date

August 31, 2026

Last Updated

February 23, 2026

Enrollment

900

ESTIMATED participants

Conditions

HIV

Interventions

Point-of-Care Cepheid Xpert HIV-1

DIAGNOSTIC_TEST

DTG/ABC/3TC

DRUG

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HIV Positive

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RECRUITINGPHASE2

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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POC HIV Testing and Early DTG Use for Infants

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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