Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The proportion of infants with grade 3 or 4 adverse events/hospitalization/death
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for point-of-care infant HIV testing:
- •Mother 18 years of age or older
- •Mother willing and able to provide verbal consent for infant testing
- •Infant birth weight ≥1.5kg
- •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)
排除标准
- •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:
- •Mother 18 years of age or older
- •Mother willing and able to provide written informed consent for study participation for herself and her infant
- •Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
- •Infant eligible for ART treatment in accordance with the Botswana government program
- •Infant birth weight ≥1.5 kg
- •Exclusion criteria for infant longitudinal treatment cohort:
- •Medical condition making it unlikely that the infant will survive to 24 months
- •Infant unable to start treatment-dose ART < 168 hours of age
- •Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
研究组 & 干预措施
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.
干预措施: DTG/ABC/3TC (Drug)
HIV-exposed neonates
Point-of-care HIV testing at birth
干预措施: Point-of-Care Cepheid Xpert HIV-1 (Diagnostic Test)
结局指标
主要结局
The proportion of infants with grade 3 or 4 adverse events/hospitalization/death
时间窗: 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.
Median time to HIV diagnosis and treatment-dose ART
时间窗: 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
时间窗: 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
时间窗: 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.
Proportion of high-risk HIV-exposed infants identified and tested
时间窗: 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.
次要结局
未报告次要终点
研究者
Roger Shapiro
Associate Professor of Immunology and Infectious Diseases
Harvard School of Public Health (HSPH)