Demonstrating service delivery models for effective initiation and retention on PrEP among Barmaids in Dar es Salaam

Not Applicable

Recruiting

Conditions: Models of delivery of Pre-Exposure Prophylaxis (PrEP) for HIV prevention
B20
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases

Registration Number: DRKS00018101

Lead Sponsor: Heidelberg Institute of Public Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 160

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

• 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>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 Outcome Measures

Name	Time	Method
Secondary objective 1: To assess whether receiving support by an omni-channel<br>(physical and virtual) PrEP Champion, improves PrEP adherence relative to the<br>national standard of care.<br><br>Secondary objective 2: To document the performance of a novel point of care urine assay as a measure of adherence to PrEP. <br><br>Additional study aim: To explore preferences for, willingness, and factors influencing uptake of Long-Acting injectable HIV PrEP among female barmaids in Ubungo Municipality.