Models of delivery of Pre-Exposure Prophylaxis (PrEP) for HIV prevention B20
Conditions
Interventions
Group 1: Barmaids randomized to the workplace-based PrEP arm will receive PrEP pills, formulated as tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, through their bar of work.
Group 2: B
Sponsors
Heidelberg Institute of Public Health
Eligibility
Sex/Gender
Female
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: • Identify as female and report being aged 15 years or older • Working in a licensed bar in Dar es Salaam Municipality (DSM) as a barmaid or server • Provide signed and dated written informed consent • State that they are willing to comply with all study procedures and available within DSM for the duration of the study • Be able to take oral medication and be willing to adhere to the medication regime
Exclusion criteria
Exclusion criteria: • Report past diagnosis of renal disease • Report past diagnosis of diabetes • Report past diagnosis of hypertension • Report current use of nephrotoxic medication • Report flu-like symptoms that may represent acute HIV infection • Report currently taking any of the following medications: o Any medicine containing emtricitabine or tenofovir disoproxil fumarate o Any medicine containing tenofovir alafenamide o Any medicine containing lamivudine o Adefovir o Didanosine o Atazanavir o Ledipasvir with sofobuvir o Darunavir o Lopanavir with ritonavir • Report bone pain or other bone problems • Test positive for HIV or be unwilling to complete HIV counselling and testing. • Test abnormally low for renal function using a serum creatinine test (<60ml/min). • Test positive for Hepatitis B based on a hepatitis B surface antigen (HBsAg) test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective 1: To assess whether workplace-based PrEP initiation for DSM barmaids at their bar of work increases the rate of PrEP initiation relative to initiation at healthcare facilities with the assistance of a peer navigator (standard of care). Primary objective 2: To determine whether workplace-based initiation and provision of PrEP refills to barmaids in DSM at their bar of work increases PrEP retention and adherence relative to routine facility-based PrEP initiation and refilling at healthcare facilities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective 1: To assess whether receiving support by an omni-channel (physical and virtual) PrEP Champion, improves PrEP adherence relative to the national standard of care. Secondary objective 2: To document the performance of a novel point of care urine assay as a measure of adherence to PrEP. Additional study aim: To explore preferences for, willingness, and factors influencing uptake of Long-Acting injectable HIV PrEP among female barmaids in Ubungo Municipality. | — |
Countries
Tanzania
Contacts
Public ContactTill Bärnighausen
Heidelberg Institute of Public Health
Outcome results
None listed