NCT05017558Unknown不适用
Operational Evaluation of the Introduction of "Point Of Care" (POC) to Optimise Post-natal Prophylaxis of HIV-exposed Newborns According to the Risk of Maternal to Child Transmission (MTCT) Assessed by Measuring Maternal Viral Load at Delivery in Conakry, Guinea
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
研究概览
简要总结
The main objective is to evaluate the operationality of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk: HIV viral load (VL) at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea.
详细描述
Intervention:
All women screened for HIV-1 infection in the delivery room, whether or not the infection was previously known, whether or not they are treated, will be eligible to participate in this study and will be offered inclusion in the study.
The women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery.
Newborns will benefit :
- the provision of antiretroviral (ARV) preventive treatment differentiated according to their risk of infection in accordance with national recommendations:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For mother:
- •Mother/child couple whose mother is HIV-1 infected, whether or not the infection is known and treated at delivery
- •Mother of full age 18 years or older
- •Mother agreeing to be contacted by telephone to ensure that appointments are respected.
- •Mother has signed the informed consent form to participate in the study (and agrees to be followed, along with her child, at the centre for the duration of the study).
- •For children:
- •Live newborn baby
- •Free, informed and written consent must be signed by the holder(s) of parental authority and the investigator for the child's participation in this research (at the latest on the day of birth and before any intervention carried out on the newborn in the trial).
排除标准
- •For mother:
- •Mother infected with HIV-2
- •Not included due to monitoring difficulties:
- •Anticipated absence(s) that could hinder participation in research (travel abroad, relocation, travel);
- •Insufficient motivation to be followed for 9 months in the centre.
- •No mobile phone or refusal to be called by investigators if necessary.
- •Mother and/or children already participating in another biomedical study
- •For children:
- •Not included for reasons of caution (child with severe congenital malformation or clinical symptomatology suggesting opportunistic infection).
- •The child has a known allergy to the drug given as part of HIV prophylaxis in Guinea or to its components.
结局指标
主要结局
Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
时间窗: Day 0 to day 2
Proportion of newborns having received antiretroviral prophylaxis within 48 hours after delivery adapted to the "real" risk of MTCT, defined by measuring the maternal viral load by POC at delivery.
次要结局
- To evaluate the intrinsic diagnostic performance of viral load measurement by POC Xpert HIV-1 in comparison with the evaluation of the level of risk by maternal interrogation alone.(Day 0 to day 2)
- To assess the proportion of women who received Xpert HIV-1 viral load test at delivery.(Day 0 to day 2)
- To assess the turn around time of Xpert HIV-1 qual test(Day 0 to week 9)
- To assess the proportion of women ready to start or continue ARV treatment ("ARV readiness") during the study, comparing the proportion of women lost to follow-up from day 0 to month 9.(Day 0 to month 9)
- To measure the satisfaction of health care staff and mothers with the use of the POC test to monitor viral load in mothers.(Day 0 to day 2)
- To assess the turn around time of Xpert HIV-1viral load(Day 0 to day 2)
- To assess the proportion of children lost to follow-up(Day 0 to month 9)
- To collect feedback from health professionals and mothers on the use of POC in the clinic.(Day 0 to week 9)
- To assess the proportion of untreated women initiating ARV treatment(Day 0 to day 2)
- To measure, in women with a VL<1000 cp/mL at delivery who do not report taking ARV, the proportion of those with ARV detectable in the plasma and the nature of those ARV detected.(Day 0 to day 2)
- Assess patient adherence to ARV treatment on the basis of ARV dosage at day 0 (only for mothers treated before delivery) and at month 6.(Day 0 to month 6)
- To assess the proportion of children who received Xpert HIV-1 qual test(Day 0 to week 9)
- To measure the satisfaction of health care workers and mothers with the use of the POC test for early infant diagnosis.(Day 0 to week 9)
- To assess the proportion of HIV-1 infected women with virological success(Month 6)
- To assess the turn around time from from sample collection to ARV treatment initiation in HIV-1 infected children(Day 0 to month 9)
- To assess the rate of mother-to-child transmission of HIV(Day 0 to month 9)
- To measure the proportion of HIV-infected children with ARV resistance mutations.(Day 0 to month 9)
- Assess patient adherence to ARV treatment on the basis of adherence questionnaires from day 0 to months 9(Day 0 to 9 month 9)
- Socio-anthropological survey: Assessment of feelings about the study among mothers, fathers, psychosocial counsellors and health professionals.(9 months)
- To measure the proportion of women reporting taking ARV before childbirth and having a detectable VL at delivery, the proportion of viruses with ARV resistance mutations.(Day 0 to day 2)
- To determine whether the stigma of the women included in the study affects the proportion lost to follow-up during the study.(Week 6 to month 9)
- To assess the proportion of HIV-1 infected children initiating ARV treatment(Day 0 to month 9)
- To assess the proportion of women practicing exclusive breastfeeding.(Day 0 to month 6)
- To assess the proportion of women lost to follow-up(Day 0 to month 9)
- To measure, in women with a VL>1000 cp/mL at delivery and reporting taking ARV, the proportion of those with ARV detectable in the plasma and the nature of these ARV detected.(Day 0 to day 2)
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