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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: t
View:

• Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).

• AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.

• Willing and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.

Locations
Other Locations
Kenya
Kenya Medical Research Institute and Partners in Health & Research Development
RECRUITING
Thika
Contact Information
Primary
Renee Heffron, PhD, MPH
rheffron@uabmc.edu
205-934-7349
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 1400
Treatments
No_intervention: Standard of Care PrEP Program
In the control phase, clinics will offer standard of care PrEP program, which includes daily oral PrEP, for young women.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Kenya Medical Research Institute, National Institute of Mental Health (NIMH), Partners in Health and Research Development
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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