Clinical trial NCT04424524: Streamlining the Efficiency of PrEP Implementation
Official title: An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
HIV Preexposure Prophylaxis
Implementation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-06-11
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient wait time
timeFrame: up to 6 months
measure: PrEP continuation
timeFrame: up to 6 months
measure: PrEP adherence
timeFrame: up to 6 months
measure: Acceptability of direct-to-pharmacy PrEP care pathway
timeFrame: up to 6 months
measure: Acceptability of user HIV self-testing for PrEP care pathway
timeFrame: up to 6 months
measure: Feasibility of direct-to-pharmacy PrEP care pathway
timeFrame: up to 6 months
Secondary outcomes:
measure: Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
timeFrame: up to 6 months
measure: Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
timeFrame: up to 6 months
measure: Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
timeFrame: up to 6 months
measure: Safety of HIV self-testing
timeFrame: up to 6 moths
measure: Reasons for PrEP discontinuation
timeFrame: up to 6 months
measure: Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Thika
country: Kenya
facility: Partners in Health Research and Development
Study officials:
affiliation: University of Washington
name: Kenneth Mugwanya, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.