NCT04558554 is a NA clinical trial of pharmacy-based PrEP delivery in HIV Prevention, sponsored by University of Washington.

Who is sponsoring NCT04558554?

NCT04558554 is sponsored by University of Washington.

What drugs are being tested in NCT04558554?

Interventions in NCT04558554: pharmacy-based PrEP delivery.

What condition does NCT04558554 study?

NCT04558554 studies HIV Prevention.

Is NCT04558554 still recruiting?

NCT04558554 is currently completed. Last updated 15 March 2024.

Are results published for NCT04558554?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-15 · How we verify

NCT04558554

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Completed NA Results posted Last updated 15 March 2024

What this trial tests

NA trial testing pharmacy-based PrEP delivery in HIV Prevention in 1,216 participants. Completed in 31 July 2022.

Timeline

26 November 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	1,216
Start date	26 November 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	2 locations across Kenya

Drugs / interventions tested

pharmacy-based PrEP delivery

Conditions studied

HIV Prevention — all drugs for HIV Prevention →

Sponsor

University of Washington

Who can join

18 and older, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PrEP Initiation Primary · Over 13-month duration of Study 1a and 6-month duration of Study 2

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

Group	Value	95% CI
Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months)	287
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	661

PrEP Retention Primary · Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2

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.

Group	Value	95% CI
Study 1a: Pharmacy-based PrEP Delivery (13 Months)	153
Study 1b: Pharmacy-based PrEP Refill (12 Months)	41
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	476
Study 1a: Pharmacy-based PrEP Delivery (13 Months)	134
Study 1b: Pharmacy-based PrEP Refill (12 Months)	65
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	185

PEP Initiation Secondary · Over 6-month duration of Study 2

Study 2: Number of participants who initiated PEP at a pilot pharmacy.

Group	Value	95% CI
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	162

Selection of Pharmacy-based PrEP Refills Secondary · During the 12-month duration of Study 1b

Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy.

Group	Value	95% CI
Study 1b: Pharmacy-based PrEP Delivery Refill (12 Months)	3

PrEP Adherence Secondary · Over 12-month duration of Study 1a and the 6-month duration of Study 2

Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence

Group	Value	95% CI
Study 1a: Pharmacy-based PrEP Delivery (13 Months)	16
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	16

STI Testing Uptake Secondary · Over 6-month duration of Study 2

Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies

Group	Value	95% CI
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	53

Transition From PEP to PrEP Secondary · Over 6-month duration of Study 2

Study 2: Percentage of participants who completed the full PEP regimen and subsequently initiated PrEP at a pilot pharmacy, among those who initiated PEP at a pilot pharmacy,

Group	Value	95% CI
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	30

PrEP Initiation Among STI Testing Clients Secondary · Over 6-month duration of Study 2

Study 2: Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit

Group	Value	95% CI
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	45

Selection of Option to Self-administer HIV Risk Assessment Screening Tool Secondary · Over 6-month duration of Study 2

Study 2: Number of participants who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it)

Group	Value	95% CI
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)	151

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation.
Ortblad KF, Mogere P, Omollo V, Kuo AP, et al · · 2023 · cited 30× · PMID 37306128 · DOI 10.1002/jia2.26131
Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya.
Haberer JE, Mugo N, Bukusi EA, Ngure K, et al · · 2022 · cited 26× · PMID 35147580 · DOI 10.1097/qai.0000000000002876
HIV self-testing: finding its way in the prevention tool box.
Ortblad KF, Stekler JD. · · 2020 · cited 18× · PMID 33250049 · DOI 10.1186/s12916-020-01852-y
Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data.
Nakambale HN, Roche SD, Mogere P, Omollo V, et al · · 2023 · cited 17× · PMID 36895656 · DOI 10.3389/frph.2023.1023568
Integration of HIV prevention and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe.
Kachale F, Mahaka I, Mhuriro F, Mugambi M, et al · · 2021 · cited 14× · PMID 37794965 · DOI 10.12688/gatesopenres.13330.2
The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya.
Omollo V, Asewe M, Mogere P, Maina G, et al · · 2023 · cited 12× · PMID 37079900 · DOI 10.1097/qai.0000000000003208
A modified pharmacy provider-led delivery model of oral HIV pre- and post-exposure prophylaxis in Kenya: a pilot study extension.
Roche SD, Omollo V, Mogere P, Asewe M, et al · · 2025 · cited 5× · PMID 40569884 · DOI 10.1002/jia2.26467
Feasibility and Impact of Community Pharmacy and Novel Pick-up Points for Antiretroviral Therapy Pre-exposure Prophylaxis Initiation and Continuation in Low and Middle-income Countries.
Lalla-Edward ST, Venter WDF. · · 2024 · cited 3× · PMID 39548044 · DOI 10.1007/s11904-024-00710-3

Verify or expand the search:

Other recruiting trials for HIV Prevention

Currently open trials in the same condition.

NCT07194902 — HIV Self-testing for Partners of HIV-uninfected Postpartum Women · NA · recruiting
NCT07218211 — Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP · Phase 4 · recruiting
NCT07349758 — Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers · Phase 1 · recruiting
NCT07433985 — California MEPS Hub · NA · recruiting
NCT07002866 — Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda · NA · recruiting

Other University of Washington trials

Trials by the same sponsor.

NCT07430852 — Inherited and Environmental Risks Acting on Body Weight · NA · not yet recruiting
NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc · Phase 2 · not yet recruiting
NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn · NA · not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04558554 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 15 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04558554.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing