Streamlining the Efficiency of PrEP Implementation

NCT04424524 | Completed DMC

• 2 other identifiers: STUDY00007949R00MH118134
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention; HIV Preexposure Prophylaxis; Implementation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics

  up to 6 months

• Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics

  up to 6 months

• Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics

  up to 6 months

• Safety of HIV self-testing

  up to 6 moths

• Reasons for PrEP discontinuation

  up to 6 months

Study Arms (2)

Direct-to-pharmacy oral PrEP refill visits

OTHER

Intervention

Other: Direct-to-pharmacy oral PrEP refill visits

Usual care

NO INTERVENTION

Control

Interventions

Direct-to-pharmacy oral PrEP refill visits OTHER

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

Direct-to-pharmacy oral PrEP refill visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Partners in Health Research and Development

Thika, Kenya

Location

Related Publications (2)

• 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.

  PMID: 38446643 RESULT

• 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.

  PMID: 40294082 DERIVED

Study Officials

• Kenneth Mugwanya, MBChB, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Global Health

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: April 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: After primary results are reported

Locations

KE (1)