drugset / Trial / NCT03988387

IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

NCT03988387

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

Timeline

Start
2019-10-31
Primary completion
2022-03-10
Completion
2022-03-10

Drugs

EvaluationDrugModalityDoseRoute
Background Tenofovir Small molecule 300 mg Oral
Background emtricitabine Other / unclassified 200 mg Oral