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

NCT05017558 | Unknown

• 1 other identifier: ANRS12412 IPOP
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mother to Child HIV Transmission

Keywords

prevention of mother to child HIV transmission; HIV 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

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 care 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

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 24, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-02