HIV InfectionsNCT05905640
One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
A study testing Method of PrEP delivery and consultation in people with HIV Infections, run by University of Washington at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Method of PrEP delivery and consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteKenya
- Study dates
- 1 Jan 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute -KEMRI
Kisumu
Benn Kwach, kwachbenn@gmail.com
About this study
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Method of PrEP delivery and consultation
- Keywords
- PrEP, HIV Prevention, PrEP adherence, Sexual behavior
- Medical subject headings
- HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of PrEP delivery and consultationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm- Usual PrEP care pathway | No intervention | 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. |
| Intervention Arm- One Stop PrEP care pathway | Other | 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. Receives: Other: Method of PrEP delivery and consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
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, Sexually transmitted infection (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).
Measured: up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial of twelve public health clinics assigned 1:1 to implement either the intervention of One stop PrEP care pathway or usual clinic flow as control.
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Principal investigator, Kenneth K Mugwanya, University of Washington
- Investigators
- Kenneth Mugwanya, MBChB, MS, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905640
- Sponsor's protocol ID
- STUDY00015873
- Other IDs
- R01MH129234-01A1
- Status last verified
- Apr 2025
- First submitted
- 12 May 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
- ClinicalTrials.gov ID
- NCT05905640
- Acronym / sponsor ID
- STUDY00015873
- Conditions
- HIV Infections
- Keywords
- PrEP, HIV Prevention, PrEP adherence, Sexual behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized trial of twelve public health clinics assigned 1:1 to implement either the intervention of One stop PrEP care pathway or usual clinic flow as control.
| Arm | Type | Receives |
|---|---|---|
| Control arm- Usual PrEP care pathway | No intervention | –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. |
| Intervention Arm- One Stop PrEP care pathway | Other | Other: Method of PrEP delivery and consultationIn 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Method of PrEP delivery and consultationAll 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. | Other | Intervention Arm- One Stop PrEP care pathway |
Primary outcome
PrEP initiation
Time frame: Years 2-4 of the study, up to 36 months.
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.
PrEP continuation
Time frame: up to 12 months of PrEP use.
PrEP continuation will determined by clinic visit attendance and pharmacy PrEP refills records obtained by abstraction of MOH clinic records.
PrEP adherence
Time frame: Years 2-4 of the study, up to 36 months.
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.
Acceptability
Time frame: Throughout the study period, up to 36 months
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.
Adoption
Time frame: Throughout the study period, up to 36 months
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.
Fidelity
Time frame: Throughout the study period, up to 36 months
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.
Total client wait time and staff time spent on PrEP services
Time frame: Throughout the study period, up to 36 months
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
Satisfaction with services
Time frame: Throughout the study period, up to 36 months
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.
Sustainability
Time frame: up to 12 months after technical assistance support is scaled back
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.
1 secondary outcome
Incremental cost of one-stop PrEP services, including costs averted, and reduced client wait times.
Time frame: up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Mugwanya, MBChB, MS, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of PrEP delivery and consultation in people with HIV Infections, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Lauff (+1-206-520-3809, alauff@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (time frame: Years 2-4 of the study, up to 36 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.