NCT04558554

Brief Summary

3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 26, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

June 5, 2020

Results QC Date

July 19, 2023

Last Update Submit

February 15, 2024

Conditions

HIV Prevention

Keywords

pre-exposure prophylaxisKenyapharmacyHIV self-testingcare pathwaypilot

Outcome Measures

Primary Outcomes (2)

  • PrEP Initiation

    Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.

    Over 13-month duration of Study 1a and 6-month duration of Study 2

  • PrEP Retention

    For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy. Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic.

    Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2

Secondary Outcomes (7)

  • PEP Initiation

    Over 6-month duration of Study 2

  • Selection of Pharmacy-based PrEP Refills

    During the 12-month duration of Study 1b

  • PrEP Adherence

    Over 12-month duration of Study 1a and the 6-month duration of Study 2

  • STI Testing Uptake

    Over 6-month duration of Study 2

  • Transition From PEP to PrEP

    Over 6-month duration of Study 2

  • +2 more secondary outcomes

Study Arms (3)

Study 1a: Pharmacy-based PrEP delivery Pilot (13 months)

EXPERIMENTAL

Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.

Other: pharmacy-based PrEP delivery

Study 1b: Pharmacy-based PrEP delivery Refill (12 months)

EXPERIMENTAL

Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics.

Other: pharmacy-based PrEP delivery

Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months)

EXPERIMENTAL

Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing.

Other: pharmacy-based PrEP delivery

Interventions

pharmacy-based PrEP deliveryOTHER

The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.

Study 1a: Pharmacy-based PrEP delivery Pilot (13 months)Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months)Study 1b: Pharmacy-based PrEP delivery Refill (12 months)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=18 years
  • Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only)
  • Initiated PrEP at a project-affiliated clinic (Study 1b only)
  • Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only)
  • Able \& willing to provide written informed consent

You may not qualify if:

  • Currently pregnant or breastfeeding (Study 1a \& 1b only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project)

Thika, Kenya

Location

Related Publications (3)

  • Ortblad KF, Kuo AP, Mogere P, Roche SD, Kiptinness C, Wairimu N, Gakuo S, Baeten JM, Ngure K. Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya. BMC Health Serv Res. 2024 May 11;24(1):618. doi: 10.1186/s12913-024-10995-0.

    PMID: 38730398DERIVED

  • Ortblad KF, Mogere P, Omollo V, Kuo AP, Asewe M, Gakuo S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi EA, Ngure K, Baeten JM. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 2023 Jun;26(6):e26131. doi: 10.1002/jia2.26131.

    PMID: 37306128DERIVED

  • Omollo V, Asewe M, Mogere P, Maina G, Kuo AP, Odoyo J, Oware K, Baeten JM, Kohler P, Owens T, Bukusi EA, Ngure K, Ortblad KF. The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya. J Acquir Immune Defic Syndr. 2023 Aug 15;93(5):379-386. doi: 10.1097/QAI.0000000000003208.

    PMID: 37079900DERIVED

Results Point of Contact

Title
Katrina Ortblad
Organization
Fred Hutchinson Cancer Center
kortblad@fredhutch.org
206.667.7267

Study Officials

  • Katrina Ortblad, MPH, ScD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: During Studies 1a, 1b, and 2, all individuals meeting study and PrEP eligibility criteria will have the option Study 2, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Study 2, a subset of four study pharmacies (2 per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate Assistant Professor, Department of Global Health

Study Record Dates

First Submitted

June 5, 2020

First Posted

September 22, 2020

Study Start

November 26, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

March 15, 2024

Results First Posted

March 15, 2024

Record last verified: 2024-02

Locations

KE(2)