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

This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.

Study Overview

• Status: Completed
• Conditions: HIV Prevention; HIV Preexposure Prophylaxis; Implementation
• Intervention / Treatment: Other: Direct-to-pharmacy oral PrEP refill visits

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: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Thika, Kenya
    • Partners in Health Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

HIV uninfected men and women accessing PrEP services at public health HIV clinics in Kenya. Data on up to 500 persons who initiate PrEP will be evaluated, both newly initiating PrEP and those continuing on PrEP (up to 250 at up clinics implementing current practice and up to 250 at clinics implementing direct-to-pharmacy PrEP refill visits). PrEP is standard of care at these clinics, recommended by Kenyan guidelines, and demand creation, PrEP eligibility assessment and provision are all performed by the facility staff following the Kenya Ministry of Health PrEP guidelines.

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

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Control
Other: Direct-to-pharmacy oral PrEP refill visits; Intervention	Other: Direct-to-pharmacy oral PrEP refill visits; Programmatic direct-to-pharmacy oral PrEP refill visits supported with client HIV self-testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient wait time	Total waiting time at the clinic and contact time with providers measured by time and motion studies	up to 6 months
PrEP continuation	Measured by return to clinic for PrEP refill	up to 6 months
PrEP adherence	Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits	up to 6 months
Acceptability of direct-to-pharmacy PrEP care pathway	Assessed by the Acceptability of Intervention Psychometric Measure (AIM)	up to 6 months
Acceptability of user HIV self-testing for PrEP care pathway	Assessed by the Acceptability of Intervention Psychometric Measure (AIM)	up to 6 months
Feasibility of direct-to-pharmacy PrEP care pathway	Assessed by the Feasibility of Intervention Psychometric Measure (FIM)	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	Evaluated through in-depth and key informants qualitative interviews	up to 6 months
Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	Evaluated through in-depth and key informants qualitative interviews	up to 6 months
Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	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	up to 6 months
Safety of HIV self-testing	Accuracy of HIV self-testing measured by frequency false negative and positive tests.	up to 6 moths
Reasons for PrEP discontinuation	Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use	up to 6 months
Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	Measured through micro-activity costing and time and motion studies	up to 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kenneth Mugwanya, MBChB, PhD, University of Washington

Publications and helpful links

General Publications

• Zewdie KB, Ngure K, Mwangi M, Mwangi D, Maina S, Etyang L, Maina G, Ogello V, Owidi E, Mugo NR, Baeten JM, Mugwanya KK. Effect of differentiated direct-to-pharmacy PrEP refill visits supported with client HIV self-testing on clinic visit time and early PrEP continuation. J Int AIDS Soc. 2024 Mar;27(3):e26222. doi: 10.1002/jia2.26222.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

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)?: YES
• IPD Plan Description: Data from Streamlining Efficiency of PrEP Implementation Study will be available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
• IPD Sharing Time Frame: After primary results are reported

Drug and device information, study documents

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