Table 3 Specific objectives and definitions of the main outcomes of the PRINCESSE project
Specific objectives | Principal outcomes | Population | Time Frame |
|---|---|---|---|
SO1. Access to care, retention, and healthcare pathways | Completion rate of quarterly visits: proportion of completed study visits | All PRINCESSE participants | Up to 24 months |
SO2. Clinical, behavioral, and social evolutions | Proportion with at least one diagnosed STI (chlamydia, gonococcus, or syphilis) detected by PCR or rapid test | All PRINCESSE participants | Up to 24 months |
Occurrence of an unwanted pregnancy in the last 12 months, orally reported | All PRINCESSE participants | Up to 24 months | |
S03. Initiation, practices, and compliance with PrEP | Initiation of PrEP: proportion having initiated PrEP | PRINCESSE participants eligible for PrEP | Over 24 months |
Adherence to PrEP: proportion being adherent (measured through self-report, pill count, and drug detection in plasma) | PRINCESSE participants on PrEP | Up to 24 months | |
SO4. Comparison of HIV care (HIV+ patients of the PRINCESSE cohort vs. HIV+ patients of the NGO Aprosam not belonging to the PRINCESSE cohort) | Number of participants in HIV care at 18 months (retention) | PRINCESSE participants who are HIV-infected at baseline + HIV-infected patients of Aprosam | 18 months |
Occurrence of virological failure: proportion with two consecutive detectable viral loads | PRINCESSE participants who are HIV-infected and have initiated antiretroviral treatment + HIV-infected patients of Aprosam | Over 24 months (survival analysis) | |
S05. Prevention and care of hepatitis B | HBV vaccination rate: proportion with complete vaccination (3 doses if HIV-negative, 4 double doses if HIV-positive) at the end of the trial | PRINCESSE participants needing hepatitis B vaccination | Over 24 months |
Initiation and number of participants on TDF (retention) for patients with treatment for HBV mono-infection | PRINCESSE participants with a positive HBs-antigen and an F3-F4 fibrosis | Over 24 months | |
Proportion with an increase in transaminase level (flares) after PrEP discontinuation | PRINCESSE participants who started and stopped PrEP and with a positive HBs-antigen | Within 12 months after PrEP discontinuation | |
SO6. Unintended consequences of the PRINCESSE intervention | Number of adverse social events occurring in participants’ daily lives | All PRINCESSE participants | Over 24 months |
Qualitative evaluation of undesired social events that occurred in the daily lives of participants and non-participants | PRINCESSE participants and non-participants FSWs in the targeted area of the intervention | Over 24 months | |
SO7. Vaginal microbiota, HPV infection types, and antimicrobial STI resistance | Proportion of cervical lesions at M0 and M12 | All PRINCESSE participants | 12 months |
Proportion of high-risk HPV infection included in quadrivalent and nonavalent vaccines at genital and anal levels at M0 and M12 | All PRINCESSE participants | 12 months | |
Proportion of M. genitalium, N. gonorrheae, C. trachomatis infections at genital level at M0 and M12 Proportion of M. genitallium and N. gonorrheae antimicrobial resistances | All PRINCESSE participants | 12 months |