Clinical trial NCT05017558: Evaluation of Measurement of Maternal Viral Load at Delivery to Optimise Post-natal Prophylaxis of HIV-exposed Newborns
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mother to Child HIV Transmission
Keywords: prevention of mother to child HIV transmission
HIV early diagnosis
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2021-08-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
timeFrame: Day 0 to day 2
Secondary outcomes:
measure: 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.
timeFrame: Day 0 to day 2
measure: To assess the proportion of women who received Xpert HIV-1 viral load test at delivery.
timeFrame: Day 0 to day 2
measure: To assess the turn around time of Xpert HIV-1viral load
timeFrame: Day 0 to day 2
measure: To measure the satisfaction of health care staff and mothers with the use of the POC test to monitor viral load in mothers.
timeFrame: Day 0 to day 2
measure: To assess the proportion of children who received Xpert HIV-1 qual test
timeFrame: Day 0 to week 9
measure: To assess the turn around time of Xpert HIV-1 qual test
timeFrame: Day 0 to week 9
measure: To measure the satisfaction of health care workers and mothers with the use of the POC test for early infant diagnosis.
timeFrame: Day 0 to week 9
measure: To collect feedback from health professionals and mothers on the use of POC in the clinic.
timeFrame: Day 0 to week 9
measure: To assess the proportion of women ready to start or continue ARV treatment ("ARV readiness") during the study, comparing the proportion of women lost to follow-up from day 0 to month 9.
timeFrame: Day 0 to month 9
measure: To determine whether the stigma of the women included in the study affects the proportion lost to follow-up during the study.
timeFrame: Week 6 to month 9
measure: To assess the proportion of untreated women initiating ARV treatment
timeFrame: Day 0 to day 2
measure: To assess the proportion of women lost to follow-up
timeFrame: Day 0 to month 9
measure: To assess the proportion of HIV-1 infected women with virological success
timeFrame: Month 6
measure: To assess the proportion of children lost to follow-up
timeFrame: Day 0 to month 9
measure: To assess the proportion of HIV-1 infected children initiating ARV treatment
timeFrame: Day 0 to month 9
measure: To assess the turn around time from from sample collection to ARV treatment initiation in HIV-1 infected children
timeFrame: Day 0 to month 9
measure: To assess the rate of mother-to-child transmission of HIV
timeFrame: Day 0 to month 9
measure: To assess the proportion of women practicing exclusive breastfeeding.
timeFrame: Day 0 to month 6
measure: To measure, in women with a VL<1000 cp/mL at delivery who do not report taking ARV, the proportion of those with ARV detectable in the plasma and the nature of those ARV detected.
timeFrame: Day 0 to day 2
measure: To measure, in women with a VL>1000 cp/mL at delivery and reporting taking ARV, the proportion of those with ARV detectable in the plasma and the nature of these ARV detected.
timeFrame: Day 0 to day 2
measure: To measure the proportion of women reporting taking ARV before childbirth and having a detectable VL at delivery, the proportion of viruses with ARV resistance mutations.
timeFrame: Day 0 to day 2
measure: To measure the proportion of HIV-infected children with ARV resistance mutations.
timeFrame: Day 0 to month 9
measure: Assess patient adherence to ARV treatment on the basis of adherence questionnaires from day 0 to months 9
timeFrame: Day 0 to 9 month 9
measure: Assess patient adherence to ARV treatment on the basis of ARV dosage at day 0 (only for mothers treated before delivery) and at month 6.
timeFrame: Day 0 to month 6
measure: Socio-anthropological survey: Assessment of feelings about the study among mothers, fathers, psychosocial counsellors and health professionals.
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References: