PRINAVIH study

Target population

The target population includes

• adults (≥18 years) who are naïve to any antiretroviral treatment (except for PrEP or PEP),
• for whom an HIV resistance genotype is available with amplification of at least the reverse transcriptase and protease regions,
• and who have not opposed participation.

Primary objective

To determine the frequency of transmission of viruses carrying at least one antiretroviral resistance mutation among all participants newly diagnosed with HIV-1.

Secondary objectives

1. Determine the frequency of resistance mutations for each therapeutic class (NRTI, NNRTI, PI, INSTI).
2. Determine the prevalence of viruses carrying resistance mutations to 0, 1, 2, 3, and 4 therapeutic classes.
3. Determine the prevalence of viruses susceptible to each of the recommended first-line antiretroviral combinations and to molecules used in PrEP/PEP.
4. Identify factors associated with the transmission of antiretroviral-resistant viruses.
5. Study the dissemination dynamics of different HIV subtypes across risk groups and geographic regions.
6. Identify new recombinant forms of HIV.
7. Detect clusters and transmission “hot spots” to inform and propose targeted prevention and care actions based on observed behaviors (e.g., posters, information stands, targeted messages on dating apps), improve access to testing and adapted prevention tools, and ensure rapid care in case of diagnosed infection.
8. Alert in case of an active transmission cluster to enable more targeted testing, prevention, and care interventions, and to contribute to the adaptation of prevention policies.
9. Contribute to European HIV antiretroviral resistance surveillance. Currently, individual resistance data are sent to the ECDC in an aggregated and disconnected format, due to the lack of a single database as proposed here, making cross-analysis impossible. Moreover, French resistance studies in chronically infected participants are performed only approximately every five years, preventing regular and rigorous comparisons with European data. The individual resistance data obtained in this project may be shared, after analysis by French researchers, with the ECDC database of new HIV diagnoses, currently transmitted via Santé Publique France.