NCT Number: NCT07076043
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.
Interested in participating?
Request Info18 year–30 year
Female
Interventional
Phase 4
Thika, Kiambu County, Kenya
Location status: Recruiting
Catherine Kiptinness, MPH
SUB_INVESTIGATOR
Kenneth Ngure, PhD
SUB_INVESTIGATOR
Nelly Mugo, MBChB
PRINCIPAL_INVESTIGATOR
Nelly Mugo, MBChB, MPH
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
Daily oral PrEP
Time frame: From enrolment to 6 months
Women who start to use PrEP
Time frame: From enrolment to 3 months
Women who continue to use PrEP 3 months since they initiated PrEP
Time frame: Enrolment to 6 months
Women who continue to use PrEP 6 months since they initiated PrEP
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Acronym: PrEMIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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