Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform

NCT ID: NCT05467306

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2026-03-31

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.

Detailed Description

In Aim 1, 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.

Pharmacy selection for cluster RCT (Aim 1): The investigators conducted a landscape analysis of all pharmacies in Kisumu, Kenya as part of the team's ongoing pharmacy-based PrEP delivery studies. In this analysis, the investigators gathered information on the types of customers who attend pharmacies, the types of services offered (e.g., HIV testing) and products purchased (e.g., contraceptive methods) at pharmacies, and availability of a separate private consultation room. The investigators will select 20 pharmacies based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms).

Randomization (Aim 1): All the pharmacies will receive standard pharmacy-based PrEP delivery and be randomized to either receive (n=10 pharmacies) or not receive (n=10 pharmacies) a nurse-navigator to assist with PrEP delivery. To ensure balance between randomization arms in terms of key site characteristics, sites will be categorized on AGYW volume (i.e., monthly number of purchases made by AGYW clients) and distribution frequency of contraceptive methods purchased (based on pharmacy log data) and restricted randomization will be used for site (cluster) allocation to intervention and control arms. Specifically, all possible randomizations that evenly distribute sites on these specified factors (AGYW client volume and distribution of contraceptive methods) into 2 study arms will be generated, and one combination will be selected using a random number generator. Randomization and allocation will be performed by a biostatistician from the UW CFAR Biometrics Core, who has no knowledge of sites other than the variables included in the restricted randomization process, and the Study Statistician, who received an MPH in Biostatistics from UW, will supervise the randomization process. Once assigned, the randomization allocation will be unblinded. Since the randomization will occur at the pharmacy level, it is impossible to blind study team members or participants to the randomization assignments. However, procedures to minimize the influence of the unblinded nature of this study on outcomes will be implemented. Ongoing data monitoring will not include information about study endpoints disaggregated by site or study arm. Only the study statistician will review data on study endpoints by study arm or facility.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nurse-Navigator Enhanced PrEP Support

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.

Group Type: EXPERIMENTAL

Nurse-Navigator Enhanced PrEP Support

Intervention Type: BEHAVIORAL

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.

Standard PrEP services

Standard PrEP services

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-Navigator Enhanced PrEP Support

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jillian Pintye

Assistant Professor: Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jillian Pintye, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kenya Medical Research Institute

Kisumu, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Meena Lenn

Role: CONTACT

mlenn@uw.edu

206 221-7322

Facility Contacts

Elizabeth Bukusi

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38890744 (View on PubMed)

Other Identifiers

R01HD108041

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00013956

Identifier Type: -

Identifier Source: org_study_id