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TelePharm PrEP/PEP

7 mei 2026 bijgewerkt door: Katrina Ortblad, Fred Hutchinson Cancer Center

Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya

In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers. The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support. The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.

Studietype

Ingrijpend

Inschrijving (Geschat)

1580

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Kenia
      • Kisumu, Kenia
        • Kenya Medical Research Institute
        • Contact:
        • Hoofdonderzoeker:
          • Elizabeth A Bukusi

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

Pharmacies

  • Registered with the Pharmacy and Poisons Board (PPB)
  • Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
  • Must have a private room where HIV testing and PrEP/PEP counseling can occur
  • >3 km from other study pharmacies
  • Willing to participate in research activities, including 2-day training for pharmacy providers
  • Willing to share pharmacy records with us
  • Sells HIVST kits that are WHO certified.

Pharmacists/remote nurses

  • ≥ 18 years old
  • Licensed pharmacist, pharmaceutical technologist, or nurse
  • Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
  • Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
  • Able and willing to provide informed consent

Clients

  • ≥ 15 years old
  • Interested in being screened for PrEP or PEP
  • Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP/PEP safety
  • Able and willing to provide informed consent

Exclusion Criteria:

Clients

  • Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
  • Currently enrolled in any other HIV vaccine or prevention trial
  • Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Telehealth support
Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).
Ander: Telehealth delivery of pharmacy PrEP/PEP
Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP. SMS support from remote nurses available between pharmacy visits.
Actieve vergelijker: Standard delivery
Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).
Ander: Standard pharmacy PrEP/PEP delivery
Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PrEP/PEP initiation
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period
18 months post implementation
PrEP/PEP continuation
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period
18 months post implementation

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PrEP initiation
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period
18 months post implementation
PEP initiation
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period
18 months post implementation
PrEP/PEP use
Tijdsspanne: 1.5 and 6 months from initiation
Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period
1.5 and 6 months from initiation
PrEP use
Tijdsspanne: 1.5 and 6 months from initiation
Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period
1.5 and 6 months from initiation
PEP use
Tijdsspanne: 1.5 and 6 months from initiation
Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period
1.5 and 6 months from initiation
PrEP refill
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP
18 months post implementation
Repeat PEP
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP
18 months post implementation
PEP-to-PrEP
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period
18 months post implementation
Engaged with 1+ product
Tijdsspanne: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients that were dispensed more than one HIV prevention product (oral PrEP, injectable PrEP, PEP, etc) over the implementation period
18 months post implementation
On-demand PrEP use
Tijdsspanne: 6 months from initiation
Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period
6 months from initiation
PEP-in-Pocket use
Tijdsspanne: 6 months from initiation
Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period
6 months from initiation
Product choice
Tijdsspanne: 18 months post implementation
Individual-level; binary outcome: % of total PrEP/PEP clients that were dispensed each type of product (e.g., oral PrEP, on- demand PrEP, PEP, DVR, etc).
18 months post implementation
PrEP adherence
Tijdsspanne: 1.5 months from initiation
Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS
1.5 months from initiation
Reach
Tijdsspanne: 18 months post implementation
Individual-level; binary outcome: % of PrEP/PEP clients in different populations of interest (e.g., men; youth <25 years); with separate evaluations by product type
18 months post implementation
Efficiency
Tijdsspanne: 18 months post implementation
Pharmacy-level; continuous outcome: Avg. duration (per visit & annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration
18 months post implementation
Fidelity
Tijdsspanne: 1.5 months post initiation
Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)
1.5 months post initiation
Sustainment
Tijdsspanne: 24 months post implementation
Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months
24 months post implementation
Acceptability
Tijdsspanne: 24 months post implementation
Individual-level; cont, binary outcome: # of unique client who find the study components acceptable; % of providers, including remote nurses, indicating acceptability; Also assessed in Aim 2 (described below)
24 months post implementation

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to use (for on-demand PrEP) at 1.5 months
Tijdsspanne: 1.5 months
Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
1.5 months
Time to use (for on-demand PrEP) at 6 months
Tijdsspanne: 6 months
Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
6 months
STI diagnosis
Tijdsspanne: 18 months post implementation
Individual-level; binary outcome: % of PrEP/PEP clients with a syndromic STI diagnosis (at any pharmacy PrEP/PEP visit)
18 months post implementation
Other drugs dispensed
Tijdsspanne: 18 months post implementation
Pharmacy-level; binary outcome: % of PrEP/PEP clients dispensed other drugs (e.g., hypertension, contraception) at their visit
18 months post implementation
HIV incidence
Tijdsspanne: 18 months
Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive
18 months
HIV risk
Tijdsspanne: 18 months post implementation
Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)
18 months post implementation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fred Hutchinson Cancer Center

Medewerkers

National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
ClickMedix LLC

Onderzoekers

  • Studie stoel: Kendall V Harkey, Fred Hutch Cancer Center
  • Studie stoel: Rachel C Malen, Fred Hutch Cancer Center
  • Hoofdonderzoeker: Katrina F Ortblad, Fred Hutch Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 maart 2028

Studie voltooiing (Geschat)

30 september 2028

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • RG1125680
  • R01MH140465 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Participant-level pharmacy record and research data will be shared through deposition of the data in an open-access public repository (Dryad). In addition to sharing the study data publicly, data dictionaries and other tools supporting use of the data will be shared.

IPD-tijdsbestek voor delen

De-identified pharmacy record and research data from this study will be deposited in the Dryad data repository within 12 months of publication.

IPD-toegangscriteria voor delen

The study data will be accessible through the Dryad data repository. For all publications, a dataset will be created that is assigned a digital object identifier (DOI), which will be referenced in the publication so the research community can easily find and access the data, if interested. The Dryad repository can also be searched by topic, institution, and investigator name, which should make it easy for other interested parties to find and access the study data.

Any study data that cannot be shared via Dryad, will be made available through a formal request to the PIs. We will share data and supporting documentation upon request to outside investigators, after scientific review, IRB approval, and obtaining relevant Data Use Agreements.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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