Streamlining the Efficiency of PrEP Implementation

NCT ID: NCT04424524

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2024-04-30

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.

Conditions

HIV Prevention; HIV Preexposure Prophylaxis; Implementation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Direct-to-pharmacy oral PrEP refill visits

Intervention

Group Type: OTHER

Direct-to-pharmacy oral PrEP refill visits

Intervention Type: OTHER

Programmatic direct-to-pharmacy oral PrEP refill visits supported with client HIV self-testing

Usual care

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Direct-to-pharmacy oral PrEP refill visits

Programmatic direct-to-pharmacy oral PrEP refill visits supported with client HIV self-testing

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kenneth K Mugwanya

Assistant Professor, School of Medicine: Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Mugwanya, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Partners in Health Research and Development

Thika, , Kenya

Countries

Kenya

References

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.

Reference Type: RESULT

PMID: 38446643 (View on PubMed)

Wairimu N, Ngure K, Ogello V, Owidi E, Mwangi P, Etyang L, Waituika W, Mwangi M, Githuku DM, Maina S, Irungu E, Mugo N, Mugwanya KK. Low HIV-risk aligned discontinuation among HIV pre-exposure prophylaxis users within public HIV clinics in Kenya: A mixed method study. PLOS Glob Public Health. 2025 Apr 28;5(4):e0004493. doi: 10.1371/journal.pgph.0004493. eCollection 2025.

Reference Type: DERIVED

PMID: 40294082 (View on PubMed)

Other Identifiers

R00MH118134

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007949

Identifier Type: -

Identifier Source: org_study_id