One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project

The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP. The investigators will evaluate data from men and women ≥15 years of age unknown to be living with HIV seeking PrEP services at public health facilities in western Kenya.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Method of PrEP delivery and consultation

Detailed Description

This study will evaluate the effectiveness of one-stop PrEP services in 12 public health facilities in Kenya. The core implementation strategies to optimize one-stop PrEP care will include training of healthcare providers, technical assistance, joint clinic supervision with the county health officials, and abstraction of program data regarding PrEP initiations and continuations including characteristics of PrEP users for quality improvement. Within this large program, the study team will recruit a nested observational cohort to obtain detailed complementary individual clinical, behavioral, and mental health outcomes (including for clients who discontinue PrEP).

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zarna Marfatia; Phone Number: 2065203866; Email: zarnam@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥15 years of age
• Accessing PrEP services at implementing clinics.
• Eligible for PrEP per Kenya national guidelines

For in-depth and key delivery informant interviews

• Able and willing to provide consent
• Provides services at participating clinics (healthcare providers)
• Key policy maker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm- Usual PrEP care pathway; At clinics that will serve as contemporaneous control clinics, eligible persons will receive PrEP according to the current client flow, which typically involves multiple room consultations. Quality improvement strategies will be promoted throughout the implementation period.
Other: Intervention Arm- One Stop PrEP care pathway; In a one-stop arm, the number of client consultation rooms in the PrEP care pathway will be reduced to a single consultation room. All core PrEP services that include HIV testing, risk assessment, clinical review PrEP initiation, prescription, dispensing, and follow-up will be performed in a one-stop consultation with a single provider. Quality improvement strategies will be promoted throughout the implementation period.	Other: Method of PrEP delivery and consultation; All core PrEP services that include HIV testing, risk assessment, clinical review PrEP initiation, prescription, dispensing, and follow-up will be performed in a one-stop consultation with a single provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation	PrEP initiation will be measured by client start of PrEP use documented on the ministry of health (MOH) tools. Data will be abstracted from MOH tools by project dedicated staff from up to 2400 persons newly initiating PrEP at the participating clinics.	Years 2-4 of the study, up to 36 months.
PrEP continuation	PrEP continuation will determined by clinic visit attendance and pharmacy PrEP refills records obtained by abstraction of MOH clinic records.	up to 12 months of PrEP use.
PrEP adherence	PrEP adherence will be measured objectively by quantification of drug levels in dried blood spots obtained at random subset visits from clients returning for PrEP refills.	Years 2-4 of the study, up to 36 months.
Acceptability	Acceptability will be determined as the perception among clients, providers, and stakeholder that one-stop PrEP services is agreeable to them. Mixed methods assessments, including user and provider surveys and qualitative interviews with users and providers will be utilized to measure acceptability. The Proctors implementation framework will be utilized to organize outcomes and to understand acceptability of one-stop and quality improvement measures at the user, clinic, and provider level. Investigators will comprehensively triangulate all data sources to understand how system, provider, and client factors interact to influence adoption.	Throughout the study period, up to 36 months
Adoption	Adoption will be determined as the proportion and characteristics of facilities adopting one-stop services. Mixed methods assessments, including provider surveys and qualitative interviews with users and providers will be utilized to measure adoption. The Proctors implementation framework will be utilized to organize outcomes and to understand adoption of one-stop and quality improvement measures at the clinic and provider level. Investigators will comprehensively triangulate all data sources to understand how system, provider, and client factors interact to influence adoption.	Throughout the study period, up to 36 months
Fidelity	Fidelity will be defined as the degree to which one-stop pathway and quality improvement measures are implemented as planned. Checklists and technical assistant reports will be used to study how implementation of one-stop pathway and quality improvement measures are implemented per protocol at provider and clinic level. Investigators will comprehensively triangulate all data sources to understand how system, provider, and client factors interact to influence adoption.	Throughout the study period, up to 36 months
Total client wait time and staff time spent on PrEP services	Efficiency will be defined as client wait time and staff time spent on PrEP services. Time will be done by observing at least 50 clinical visits per arm to assess wait time and staff time spent on counseling, HIV testing, clinical review, and PrEP provision	Throughout the study period, up to 36 months
Satisfaction with services	Satisfaction will be defined ad fulfillment or happiness with one-stop service experience. Within the program we will use cross-sectional quantitative exit surveys administered to random clients at clinic to understand quality of care services and satisfaction with services.	Throughout the study period, up to 36 months
Sustainability	Sustainability will be defined as the number of clinics using one-stop at 6, 12 months after TA. Checklists and technical assistant reports will be used to document implementation of one-stop after technical assistance support is scaled back The Proctors implementation framework will be use organize implementation outcomes. Investigators will comprehensively triangulate all data sources to understand how system, provider, and client factors interact to influence continuation of PrEP.	up to 12 months after technical assistance support is scaled back

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost of one-stop PrEP services, including costs averted, and reduced client wait times.	Micro-costing studies will be conducted during the implementation of one-stop PrEP delivery in intervention clinics as well as the current practice arm using activity-based approaches for costs incurred (start-up activities, clinic-wide training, recruitment, PrEP service delivery, including HIV testing, PrEP drugs, STI treatment, creatinine testing, and follow-up) and direct program costs averted (health costs saved by averting HIV infections, personnel costs averted as result of providing PrEP in one stop).	up to 36 months.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Kenya Medical Research Institute; Jomo Kenyatta University of Agriculture and Technology
• Investigators: Principal Investigator: Kenneth Mugwanya, MBChB, MS, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention; Sexual behavior; PrEP adherence
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: STUDY00015873; R01MH129234-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No