Conditions

Mother to Child HIV Transmission

Keywords

prevention of mother to child HIV transmissionHIV early diagnosis

Outcome Measures

Primary Outcomes (1)

Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
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.
Day 0 to day 2

Secondary Outcomes (25)

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-1viral load
Day 0 to day 2
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 proportion of children who received Xpert HIV-1 qual test
Day 0 to week 9
+20 more secondary outcomes

Study Arms (1)

intervention

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:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery \< 1000 copies/mL) in Conakry, Guinea.

Diagnostic Test: point of care

Interventions

point of careDiagnostic test

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

intervention

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery \< 1000 copies/mL) in Conakry, Guinea.

You may qualify if:

For mother:

Sponsors & Collaborators

ANRS, Emerging Infectious Diseases
Governmentlead

Study Sites (1)

Pr Mohamed Cisse

Conakry, CHU Ignace Deen Guinee, Guinea

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (1)

intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (1)

intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations