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

> **NIH NIH P01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2024 · $204,065

## Abstract

Project Summary/Abstract, Point-of-Care HIV Testing and Early Dolutegravir Use for Infants (Project 3) 
The stakes of delaying HIV diagnosis and treatment in infancy are high. Infants progress to AIDS and die at a 
higher rate than any other age group, with over 30% of deaths occurring in the first 42 days of life. Even when 
treatment is started for infants, the available treatment regimens are limited – current recommendations include 
drugs such as nevirapine, zidovudine, or lopinavir/ritonavir (LPV/r) that are rarely used in adults – and treatment 
failure is common. Studies on the use of newer agents in children are lacking, leading to a reluctance to use 
newer agents in guidelines even after their approval for infants. Dolutegravir (DTG) was approved for use in 
infants from 30 days of life in June 2020, but has not become the first-line treatment regimen for infants in any 
current ART program in Africa. There is therefore an urgent need for implementation research to embed early 
infant diagnostics at the time of birth within national treatment programs in Africa, and to begin using modern 
DTG-based ART regimens for infants from as early in life as possible. 
With the support of Botswana's Ministry of Health and Wellness and this P01 program, the Botswana–Harvard 
AIDS Institute Partnership is uniquely positioned to pioneer a research program to support birth diagnosis and 
DTG treatment for infants in Botswana. Building on prior research within the Early Infant Treatment (EIT) Study, 
we will implement targeted birth testing (screening only exposed infants with the highest risk of HIV acquisition) 
by facility-based point-of-care (POC) testing with the Cepheid Xpert platform. Infants with HIV will be treated 
immediately, and referred for enrollment into a cohort that is transitioned to DTG-based ART at four weeks of 
life and followed for at least 96 weeks. With comparisons to alternate diagnostic approaches and to children who 
received LPV/r-based ART within the EIT Study, the study design will allow us to 1) evaluate the feasibility of 
adding low-cost, targeted early infant diagnosis to the Botswana national treatment program; 2) quantify the 
number of children identified as HIV infected at birth and determine time from diagnosis to ART initiation when 
POC testing is deployed; 3) compare the time to suppression and 12-week suppression between DTG-based 
and LPV/r-based ART; and 4) compare 96-week outcomes and overall viral suppression between DTG-based 
and LPV/r-based ART. Results from this study will inform programs that wish to implement birth diagnostics and 
early infant treatment with DTG-based ART, and will answer critical questions regarding the clinical, virologic, 
and immunologic impact of early DTG-based ART.

## Key facts

- **NIH application ID:** 10914860
- **Project number:** 5P01HD107670-04
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Roger L Shapiro
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $204,065
- **Award type:** 5
- **Project period:** 2021-09-24 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10914860

## Citation

> US National Institutes of Health, RePORTER application 10914860, Point-of-Care HIV Testing and Early Dolutegravir Use for Infants (5P01HD107670-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10914860. Licensed CC0.

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