About this trial
Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators 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. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study 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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Multiple Product PrEP Program
DrugIn 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.
Routine Oral PrEP
DrugDaily oral PrEP
Treatment groups
Trial outcomes
Primary outcomes
PrEP initiation
Women who start to use PrEP
Secondary outcomes
PrEP persistence at 3 months
Women who continue to use PrEP 3 months since they initiated PrEP
Other outcomes
PrEP persistence at 6 months
Women who continue to use PrEP 6 months since they initiated PrEP
Locations
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Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
University of Washington
Collaborator
Kenya Medical Research Institute
Collaborator
National Institute of Mental Health (NIMH)
Collaborator