NCT05017558

Evaluation of Measurement of Maternal Viral Load at Delivery to Optimise Post-natal Prophylaxis of HIV-exposed Newborns

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 : 1. the provision of antiretroviral (ARV) preventive treatment differentiated according to their risk of infection in accordance with national recommendations: * High risk (maternal VL ≥1000 cp/ml): zidovudine (AZT)/ nevirapine (NVP) for 12 weeks. * Low risk (maternal VL \<1000 cp/ml): NVP for 6 weeks. 2. early and regular virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection. 3. In the event of a positive HIV test, the child will initiate immediate antiretroviral treatment combining zidovudine (AZT)/ lamivudine (3TC)/ Lopinavir-retonivir (LPV/r) and a confirmatory test will be done by POC (Cepheid GenXpert HIV-1 viral load) according to World Health Organisation (WHO) and national recommendations. 4. support from the project team and peers, volunteers from the association Fédération Espoir Guinée (FEG), to improve retention in care and compliance of mother and child, promotion of exclusive breastfeeding for 6 months and family nutritional support, Cotrimoxazole (CTX) prophylaxis and the Expanded Programme on Immunization will be provided by the national programme.

Conditions

• Mother to Child HIV Transmission

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	point of care	HIV-1 infected women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery. Newborns will benefit : 1. Antiretroviral preventive treatment differentiated according to their risk of infection in accordance with national recommendations: * High risk (maternal VL ≥1000 cp/ml): AZT/NVP for 12 weeks. * Low risk (maternal VL \<1000 cp/ml): NVP for 6 weeks. 2. virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection. 3. In the event of a positive HIV test, the child will initiate immediately AZT/3TC/LPV/r 4. support from volunteers to improve retention in care, promotion of exclusive breastfeeding and family nutritional support

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-08-24
• Last updated: 2022-02-16