One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
2 other identifiers
interventional
2,400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jan 2024
Typical duration for not_applicable hiv-infections
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
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
April 17, 2025
April 1, 2025
3.3 years
May 12, 2023
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 (TA) 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 technical assistance (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 used to 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 Outcomes (1)
Incremental cost of one-stop PrEP services, including costs averted, and reduced client wait times.
up to 36 months.
Study Arms (2)
Control arm- Usual PrEP care pathway
NO INTERVENTIONAt 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.
Intervention Arm- One Stop PrEP care pathway
OTHERIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institute of Mental Health (NIMH)collaborator
- Kenya Medical Research Institutecollaborator
- Jomo Kenyatta University of Agriculture and Technologycollaborator
Study Sites (1)
Kenya Medical Research Institute -KEMRI
Kisumu, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Mugwanya, MBChB, MS, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor: Global Health
Study Record Dates
First Submitted
May 12, 2023
First Posted
June 15, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
April 17, 2025
Record last verified: 2025-04