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

Not Applicable

Recruiting

• Conditions: Hiv
• Interventions: Drug: Multiple Product PrEP Program

• Registration Number: NCT07076043
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2028-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Product PrEP Program	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.

Primary Outcome Measures

Name	Time	Method
PrEP initiation	From enrolment to 6 months	Women who start to use PrEP

Secondary Outcome Measures

Name	Time	Method
PrEP persistence at 3 months	From enrolment to 3 months	Women who continue to use PrEP 3 months since they initiated PrEP

Trial Locations

Locations (1)

Kenya Medical Research Institute and Partners in Health & Research Development; 🇰🇪 Thika, Kiambu, Kenya