Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
2 other identifiers
interventional
1,900
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started May 2023
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 13, 2026
June 1, 2025
3.9 years
July 13, 2022
May 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
PrEP initiation
Binary endpoint (Yes/No) based on self-reported use of daily oral PrEP pills or the DPV-VR at 1-month follow-up after acceptance at enrollment. Self-reported PrEP use will be considered initiation. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance, the participant will be considered non-initiated
At enrollment
PrEP persistence
Binary endpoint (Yes/No) based on self-reported persistent use of daily oral PrEP pills or the DPV-VR at 10-month follow-up after initiation at 1-month follow-up. Self-reported PrEP use will be considered persistence. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance or discontinued PrEP before 10 months, the participant will be considered non-persistent
at 10 months
Study Arms (2)
Nurse-Navigator Enhanced PrEP Support
EXPERIMENTALPharmacies 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.
Standard PrEP services
NO INTERVENTIONStandard PrEP services
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kenya Medical Research Institute
Kisumu, Kenya
Related Publications (1)
Lagat HK, Pintye J, Harrington E, Houck S, Kwena Z, Lenn M, Mogaka F, Momanyi V, Mugambi M, Nyerere B, Odoyo J, Omollo V, Ortblad KF, Rota G, Sharma M, Bukusi EA. Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial. Trials. 2024 Jun 19;25(1):394. doi: 10.1186/s13063-024-08206-6.
PMID: 38890744DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jillian Pintye, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor: Global Health
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 20, 2022
Study Start
May 17, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
May 13, 2026
Record last verified: 2025-06