Streamlining the Efficiency of PrEP Implementation

Not Applicable

Completed

• Conditions: HIV Prevention; Implementation; HIV Preexposure Prophylaxis
• Interventions: Other: Direct-to-pharmacy oral PrEP refill visits

• Registration Number: NCT04424524
• Lead Sponsor: University of Washington

Brief Summary

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.

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 Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-11
• Primary Completion: 2023-06-30
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 746

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.

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Exclusion Criteria

• Not meeting any of the inclusion criteria listed above.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct-to-pharmacy oral PrEP refill visits	Direct-to-pharmacy oral PrEP refill visits	Intervention

Primary Outcome Measures

Name	Time	Method
Patient wait time	up to 6 months	Total waiting time at the clinic and contact time with providers measured by time and motion studies
PrEP continuation	up to 6 months	Measured by return to clinic for PrEP refill
PrEP adherence	up to 6 months	Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
Acceptability of user HIV self-testing for PrEP care pathway	up to 6 months	Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Acceptability of direct-to-pharmacy PrEP care pathway	up to 6 months	Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
Feasibility of direct-to-pharmacy PrEP care pathway	up to 6 months	Assessed by the Feasibility of Intervention Psychometric Measure (FIM)

Secondary Outcome Measures

Name	Time	Method
Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	up to 6 months	Evaluated through in-depth and key informants qualitative interviews
Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	up to 6 months	Evaluated through in-depth and key informants qualitative interviews
Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	up to 6 months	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
Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics	up to 6 months	Measured through micro-activity costing and time and motion studies
Safety of HIV self-testing	up to 6 moths	Accuracy of HIV self-testing measured by frequency false negative and positive tests.
Reasons for PrEP discontinuation	up to 6 months	Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use

Trial Locations

Locations (1)

Partners in Health Research and Development; 🇰🇪 Thika, Kenya