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TelePharm PrEP/PEP

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1580

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kenya
      • Kisumu, Kenya
        • Kenya Medical Research Institute
        • Kontakt:
        • Ledende efterforsker:
          • Elizabeth A Bukusi

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Andet: 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.
Aktiv komparator: 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).
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PrEP/PEP initiation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PrEP initiation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP
18 months post implementation
Repeat PEP
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to use (for on-demand PrEP) at 1.5 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 18 months
Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive
18 months
HIV risk
Tidsramme: 18 months post implementation
Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)
18 months post implementation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fred Hutchinson Cancer Center

Samarbejdspartnere

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

Efterforskere

  • Studiestol: Kendall V Harkey, Fred Hutch Cancer Center
  • Studiestol: Rachel C Malen, Fred Hutch Cancer Center
  • Ledende efterforsker: Katrina F Ortblad, Fred Hutch Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RG1125680
  • R01MH140465 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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