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

HIV Clinical Trial

— Moso  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393193
• Other study ID #: 155BHP
• Secondary ID: P01HD107670
• Status: Recruiting
• Phase: Phase 4
• Start date: July 4, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: July 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Gbolahan Ajibola, MBBS, MPH
• Phone: +267-390-2671
• Email: gajibola[@]bhp.org.bw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: August 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Botswana	Botswana Harvard HIV/AIDS Institute Partnership	Gaborone

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	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

Country where clinical trial is conducted

Botswana, 

Outcome

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