Streamlining the Efficiency of PrEP Implementation

University of Washington

Status: Completed

Conditions: HIV Preexposure Prophylaxis; Implementation; HIV Prevention

Treatments: Other: Direct-to-pharmacy oral PrEP refill visits

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04424524

STUDY00007949

R00MH118134 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 746 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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746 participants in 2 patient groups

Direct-to-pharmacy oral PrEP refill visits

Other group

Description:

Intervention

Treatment:

Other: Direct-to-pharmacy oral PrEP refill visits

Usual care

No Intervention group

Description:

Control