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NCT Number: NCT05393193

POC HIV Testing and Early DTG Use for Infants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Botswana Harvard Health Partnership

Gaborone, Botswana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for point-of-care infant HIV testing:

  • 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)

Exclusion criteria

for point-of-care infant HIV testing:

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

Inclusion criteria

for infant longitudinal treatment cohort:

  • 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

Exclusion criteria

for infant longitudinal treatment cohort:

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of high-risk HIV-exposed infants identified and tested

    Time frame: 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.

  2. Median time to HIV diagnosis and treatment-dose ART

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 26, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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