NCT07076043

Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, we will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. We will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. Our primary aim will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

Conditions

• Hiv

Interventions

Type	Name	Description
DRUG	Multiple Product PrEP Program	In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.

Timeline

• Start date: 2025-06-03
• Primary completion: 2028-12-30
• Completion: 2029-12-30
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: Kenya