NCT05017558Completed
Evaluation of Measurement of Maternal Viral Load at Delivery to Optimise Post-natal Prophylaxis of HIV-exposed Newborns
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 70 (actual)
- First submitted
- 19 Jul 2021
- Start date
- 3 Mar 2023
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- HIV
- NCT number
- NCT05017558
What you commit to
- Study type: Observational
- Participants enrolled: 70
- From 3 Mar 2023 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Mother infected with HIV-2
- 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.
Other
- For mother:
- 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:
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pr Mohamed Cisse Coordinator of this site? Confirm its status | Conakry | Guinea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.