Prevention of Mother-to-child Transmission of HIV-1: Programme Evaluation and Innovative Responsive Intervention Integrated in the Expanded Programme of Immunization. PROMISE-EPI Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,506
- 试验地点
- 6
- 主要终点
- Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
研究概览
简要总结
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to: 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit
详细描述
In the vast majority of sub-Saharan African countries, all mothers attend an immunization (EPI) visit when their child is 6 to 8 weeks old (the first EPI visit for BCG and OPV0 vaccination, takes place at childbirth).
This study primarily aims at utilizing existing strategies to prevent postnatal HIV-1 transmission through optimizing the use of lamivudine as pre-exposure prophylaxis (PrEP) for at risk children. For this purpose, the study will use recently marketed diagnostic point of care (POC) tests at the first level of care for maternal HIV-1 viral load and early infant diagnosis (EID). This POC early infant diagnosis will also allow optimizing treatment of HIV-infected infants by offering to all the benefits of an early ART initiation.
The hypothesis is that the second visit for routine vaccination (Expanded Program of Immunization visit 2: EPI-2) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions. The EPI visit will allow an opportunity to:
- Assess the efficacy of the PMTCT cascade.
- Identify HIV-1-infected children early and refer them for early initiation of treatment
- Provide their children with an antiretroviral drug that can protect them from HIV-1, irrespective of their mother's adherence to ART as part of the Phase III Randomized Controlled Trial.
The Phase III RCT will be testing a rescue preventive intervention among HIV-1-uninfected children exposed to HIV-1 by their HIV-1-infected breastfeeding mothers against a control routine Option B+ implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A mother/infant pair will be included in the Phase III trial if the infant:
- •Is a singleton
- •Is breastfed at 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)
- •Has a negative HIV-1 PCR POC test at 2 months of age
- •Has a mother who:
- •Is the accompanying person to visit 2 of the EPI
- •Is 15 years of age or older (in Zambia) and 20 years of age or older (in Burkina Faso) or
- •If between 15 and 19 years of age (inclusive) in Burkina Faso, and is accompanied by a referent adult of her choice representing her interests and the interests of the child (parent, family member or guardian, member of an association, etc.)
- •Has been confirmed to be infected with HIV-1 (with or without HIV-2)
- •Has signed the consent form to participate For the mother in Zambia, the consent must be signed by herself and a witness; For the mother in Burkina Faso, the consent must be signed by herself and a witness (if illiterate) and/or a referent adult (if under 20 years of age in Burkina Faso).
- •For the child in Zambia, the consent must be signed by the mother. For the child in Burkina Faso, the consent must be signed by the mother and/or a referent adult (if under 20 years of age in Burkina Faso. In Burkina Faso, both parents need to sign the consent unless the mother exercises sole parental authority or if obtaining the father's consent is likely to endanger the mother and her child. In Zambia, the mother exercises sole parental authority.
排除标准
- •A mother-child couple will not be included if the child:
- •Has clinical symptoms or biological abnormalities of DAIDS classification 3 or 4 for adverse events on the day of inclusion
- •Has a severe congenital malformation
- •Has a known allergy to the study drug or its components
- •Takes emtricitabine concomitantly
- •Has a mother who:
- •Lives outside the study area or intending to move from the area within the next 12 months
- •Is participating in another clinical trial
研究组 & 干预措施
Intervention
Children infected with HIV-1 will be referred to the National Programme for confirmed HIV diagnosis and immediate ART.
For children that are not HIV-1 infected, the results on the mother's viral load will guide the next steps:
Mothers with a detectable plasma viral load (≥ 1000 copies/mL): their children will be initiated on lamivudine oral solution.
Mothers with an undetectable viral loads (<1000 copies/mL): their children will not be initiated on lamivudine oral solution at 6-8 weeks of age. However, additional monitoring on the viral load of the mother and the diagnosis of the child will take place at 6 months: If the maternal plasmatic viral load is ≥ 1000 copies/mL, the child will be initiated on lamivudine oral solution.
干预措施: Lamivudine Oral Solution (Drug)
结局指标
主要结局
Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
时间窗: 12 months
Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding
次要结局
- Evaluation of the efficacy for all the participants of the intervention arm and the comparison arm sub-population following the 2020 Zambian guidelines implementation:(12 months)
- Evaluation of the efficacy for all the participants of the intervention arm and the comparison arm sub-population before the introduction of the 2020 Zambian guidelines (including Burkina Faso control arm)(12 months)
- Evaluation of the diagnostic performance of plasma HIV viral load in comparison to breastmilk viral load to identify infants at risk of transmission at 6-8 weeks, 6 months and 12 months(6-8 weeks, 6 months, 12 months)
- Access to ART for HIV-1 positive children(6 months)
- Assessment of PMTCT cascade(2 months)
- Evaluation of the safety for all the participants of the intervention arm and the comparison arm sub-population following the 2020 Zambian guidelines implementation(12 months)
- Evaluation of the safety for all the participants of the intervention arm and the comparison arm sub-population before the introduction of the 2020 Zambian guidelines (including Burkina Faso control arm)(12 months)