- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424524
Streamlining the Efficiency of PrEP Implementation (Efficiency)
An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya
Study Overview
Status
Detailed Description
A prospective, pilot implementation evaluation of patient-centered differentiated care service. The core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in PrEP delivery is in part at the system level, above and beyond the individual client encounter. For this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design.
The specific aims are:
Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP continuation, and 3) adherence.
Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated PrEP delivery model.
Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated PrEP care.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Justice Quame-Amaglo
- Phone Number: 206-520-3866
- Email: quamaglo@uw.edu
Study Locations
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Thika, Kenya
- Recruiting
- Partners in Health Research and Development
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Contact:
- Elizabeth Irungu, MBChB, MPH
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Contact:
- Email: eirungu@uw.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
For HIV-negative participants:
- Of legal age (≥18 years)
- Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
- HIV uninfected based on negative HIV tests, per Kenya national guidelines
- Currently or previously accessed PrEP at participating HIV clinic
For Key delivery informants:
- Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
- Works at any of the clinics implementing PrEP delivery. Key informants may include HIV testing service nurses, counselors, clinicians, social workers, or clinic managers.
Exclusion Criteria:
- Not meeting any of the inclusion criteria listed above.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient wait time
Time Frame: up to 6 months
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Total waiting time at the clinic and contact time with providers measured by time and motion studies
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up to 6 months
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PrEP continuation
Time Frame: up to 6 months
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Measured by return to clinic for PrEP refill
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up to 6 months
|
PrEP adherence
Time Frame: up to 6 months
|
Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
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up to 6 months
|
Acceptability of direct-to-pharmacy PrEP care pathway
Time Frame: up to 6 months
|
Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
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up to 6 months
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Acceptability of user HIV self-testing for PrEP care pathway
Time Frame: up to 6 months
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Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
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up to 6 months
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Feasibility of direct-to-pharmacy PrEP care pathway
Time Frame: up to 6 months
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Assessed by the Feasibility of Intervention Psychometric Measure (FIM)
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up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time Frame: up to 6 months
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Evaluated through in-depth and key informants qualitative interviews
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up to 6 months
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Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time Frame: up to 6 months
|
Evaluated through in-depth and key informants qualitative interviews
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up to 6 months
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Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time Frame: up to 6 months
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Extent to which core components of the direct-to-pharmacy PrEP care pathway are implemented as intended will be evaluated through checklists and surveys with clinic managers
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up to 6 months
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Safety of HIV self-testing
Time Frame: up to 6 moths
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Accuracy of HIV self-testing measured by frequency false negative and positive tests.
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up to 6 moths
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Reasons for PrEP discontinuation
Time Frame: up to 6 months
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Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use
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up to 6 months
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Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
Time Frame: up to 6 months
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Measured through micro-activity costing and time and motion studies
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up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Mugwanya, MBChB, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00007949
- R00MH118134 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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