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

NCT ID: NCT05017558

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

point of care

Intervention Type: DIAGNOSTIC_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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ANRS12412 IPOP

Identifier Type: -

Identifier Source: org_study_id