HIV
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTPoint-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.
DRUGDTG/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.
Sponsors
Harvard School of Public Health (HSPH)
Botswana Harvard AIDS Institute Partnership
Ragon Institute of MGH, MIT and Harvard
Botswana Ministry of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of high-risk HIV-exposed infants identified and tested | 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. |
| Median time to HIV diagnosis and treatment-dose ART | 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. |
| The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART | 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. |
| The proportion of children with successful DTG-based treatment through 96 weeks on ART | 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. |
| The proportion of infants with grade 3 or 4 adverse events/hospitalization/death | 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. |
Countries
Botswana
Contacts
PRINCIPAL_INVESTIGATORRoger L Shapiro, MD, MPH
Harvard School of Public Health (HSPH)
Outcome results
None listed