The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,216
- 试验地点
- 2
- 主要终点
- 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
研究概览
简要总结
The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed until the infants reach the age of 18 - 24 months and semi-structure interviews with a sub-set of these women. A second study component involves semi-structured interviews with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the selected study facilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented HIV infection
- •Pregnant, in the last trimester of pregnancy or within two weeks post-delivery.
- •Participation in the PMTCT program during antenatal care at one of the study sites
- •Planning on remaining in the Kigali area after delivery
- •Able and willing to give informed consent for study participation for herself and her infant(s).
- •If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents
排除标准
- •Women not willing to provide informed consent to participate
研究组 & 干预措施
Infants
HIV exposed infants
干预措施: Standard of care (Other)
Healthcare workers
Facility based healthcare workers
干预措施: Semi-structured interviews (Other)
Mothers
HIV Infected mothers
干预措施: Standard of care (Other)
Mothers
HIV Infected mothers
干预措施: Semi-structured interviews (Other)
结局指标
主要结局
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
时间窗: 18 - 24 months
次要结局
- Infants and young children breastfed (exclusive or any breastfeeding) at various ages(18 - 24 months)
- HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages(18 - 24 months)
- Adherence to the universal antiretroviral therapy (ARV) regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children, including the proportion of study women with HIV RNA < 1000 copies/ml or > 2 log10 copies/mL decrease in viral(18 - 24 months)