Clinical trial NCT05393193: POC HIV Testing and Early DTG Use for Infants
Official title: Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: Ragon Institute of MGH, MIT and Harvard
name: Botswana Ministry of Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-05-26
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of high-risk HIV-exposed infants identified and tested
timeFrame: within 72 hours of life
measure: Median time to HIV diagnosis and treatment-dose ART
timeFrame: 7 days
measure: The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART
timeFrame: 12 weeks on ART
measure: The proportion of children with successful DTG-based treatment through 96 weeks on ART
timeFrame: 96 weeks on ART
measure: The proportion of infants with grade 3 or 4 adverse events/hospitalization/death
timeFrame: 96 weeks on ART
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard HIV/AIDS Institute Partnership
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Roger L Shapiro, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: