Hiv
Conditions
Keywords
HIV prevention, PrEP, Adolescent girls and young women, Kenya, stepped wedge cluster randomized trial
Brief summary
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.
Interventions
DRUGMultiple 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.
DRUGRoutine Oral PrEP
Daily oral PrEP
Sponsors
University of Alabama at Birmingham
University of Washington
Kenya Medical Research Institute
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
for Adolescent Girls and Young Women seeking reproductive health services: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation | From enrolment to 6 months | Women who start to use PrEP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP persistence at 3 months | From enrolment to 3 months | Women who continue to use PrEP 3 months since they initiated PrEP |
Countries
Kenya
Contacts
CONTACTRenee Heffron, PhD, MPH
PRINCIPAL_INVESTIGATORNelly Mugo, MBChB, MMed, MPH
Kenya Medical Research Institute
Outcome results
None listed