Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
University of Washington
1,900 participants
May 17, 2023
INTERVENTIONAL
Conditions
Summary
The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.
Eligibility
Inclusion Criteria6
- Female gender
- Seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age between ≥14 and \<25 years old
- Willingness to receive PrEP screening per national guidelines including HIV testing
- Not currently taking PrEP
- Able and willing to provide informed consent for participation
Exclusion Criteria6
- Male gender
- Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
- Age \<14 and \>24 years old
- Not willing to receive PrEP screening per national guidelines including HIV testing
- Currently taking PrEP
- Not able and/or willing to provide informed consent for participation
Interventions
Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits.
Locations(1)
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NCT05467306