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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Diagnostic test: Point-of-Care Cepheid Xpert HIV-1; Drug: DTG/ABC/3TC

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gbolahan Ajibola, MBBS, MPH; Phone Number: +267-390-2671; Email: gajibola@bhp.org.bw

Study Locations

• Botswana
  • Gaborone, Botswana
    • Recruiting
    • Botswana Harvard HIV/AIDS Institute Partnership
    • Contact: Joseph Makhema, MD; Phone Number: +267-390-2671; Email: jmakhema@bhp.org.bw
    • Sub-Investigator: Joseph Makhema, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HIV-exposed neonates; Point-of-care HIV testing at birth	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.
Other: HIV-positive infants identified through birth HIV screening; Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ragon Institute of MGH, MIT and Harvard; Botswana Harvard AIDS Institute Partnership; Botswana Ministry of Health
• Investigators: Principal Investigator: Roger L Shapiro, MD, MPH, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 155BHP; P01HD107670 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No