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COMPLETED
NCT05017558

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2023-03-03

Completion Date

2026-04-12

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

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

Locations (1)

Pr Mohamed Cisse

Conakry, CHU Ignace Deen Guinee, Guinea