MPrEP+ activities and procedures by time point
| Activities and procedures | Pre-enrolment | Baseline | Month 1 | Month 3 | Month 6 |
| Screening and enrolment | |||||
| Eligibility screen | Pre-screen | Eligibility checklist | |||
| Informed consent | X | ||||
| Clinical and laboratory | |||||
| HIV rapid testing | X | X | X | X | |
| Venipuncture | X Creatinine and HBsAg for PrEP safety | X Detection of PrEP drug concentration in plasma | X Detection of PrEP drug concentration in plasma | ||
| Urine assay for STIs (chlamydia, gonorrhoea and trichomoniasis) | X | ||||
| Clinical exam (symptom-driven) | X | X | X | X | |
| MPrEP+ intervention components | |||||
| Oral PrEP (FTC/TDF) | 30-day supply | 2- month supply | 3-month supply | Referral for post-intervention PrEP | |
| POC UrSure urine assay (with tailored HIV risk-reduction counselling) | X | X | |||
| HIVST | X | X | X | ||
| SMS text messaging | X | X | X | ||
| Interview domains | |||||
| Quantitative | |||||
| Demographics and mobility | X | X | X | X | |
| HIV risk perception | X | X | |||
| Knowledge of HIV | X | ||||
| HIV testing history | X | X | X | X | |
| STI history | X | X | X | ||
| Global social support | X | X | |||
| Experience purchasing sex | X | X | X | X | |
| Beliefs and attitudes about sex work | X | ||||
| Stigma related to engaging with FSW43 | X | ||||
| Violence44 45 | X | X | X | ||
| Sexual partnerships and practices | X | X | X | X | |
| Alcohol and use of other drugs | X | X | X | ||
| Mental health (depression) | X | X | |||
| Use of STI services | X | X | X | ||
| Knowledge and attitudes about PrEP/PEP | X | X | X | ||
| Impact of COVID-19 | X | X | X | ||
| PrEP adherence and discontinuation | X | X | X | ||
| Acceptability of study components | X | X | X | ||
| Adverse events screening (including social harms) | X | X | X | ||
| Qualitative | |||||
| Exploration of good and bad things about taking PrEP; reasons for wanting to continue or discontinue taking PrEP on study completion; experience participating in the study | X | X | X | ||
*Only for those who report discontinuation of PrEP at month 1 and month 3 visits.
HBsAg, hepatitis B surface antigen; PEP, post-exposure prophylaxis; POC, point of care; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection; TDF/FTC, tenofovir/emtricitabine.