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HIVNCT07561658

TelePharm PrEP/PEP

A study testing Telehealth delivery of pharmacy PrEP/PEP and Standard pharmacy PrEP/PEP delivery in people with HIV, run by Fred Hutchinson Cancer Center at 1 site in Kenya.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Telehealth delivery of pharmacy PrEP/PEP and Standard pharmacy PrEP/PEP delivery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,580 participants
Where
1 siteKenya
Study dates
1 Oct 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katrina F Ortblad contact

206-667-7267

kortblad@fredhutch.org

Kenya1 site

  • Kenya Medical Research Institute

    Kisumu

    Elizabeth A Bukusi, +254-572021036, ebukusi@rctp.or.ke

    Elizabeth A Bukusi

Other trials in Kenya

About this study

Official title: 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.

Read the detailed description

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.

Conditions
HIV
Being tested
Telehealth delivery of pharmacy PrEP/PEP, Standard pharmacy PrEP/PEP delivery
Keywords
Kenya, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), Pharmacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth delivery of pharmacy PrEP/PEPOther

    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.

  • Standard pharmacy PrEP/PEP deliveryOther

    Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.

Study groups in NCT07561658
Study groupRoleWhat they receive
Telehealth supportExperimentalPharmacy 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).
Receives: Other: Telehealth delivery of pharmacy PrEP/PEP
Standard deliveryActive comparatorPharmacy 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).
Receives: Other: Standard pharmacy PrEP/PEP delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP/PEP initiation

    Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period

    Measured: 18 months post implementation

  2. PrEP/PEP continuation

    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

    Measured: 18 months post implementation

Secondary outcomes (18)

  1. PrEP initiation

    Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period

    Measured: 18 months post implementation

  2. PEP initiation

    Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period

    Measured: 18 months post implementation

  3. PrEP/PEP use

    Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period

    Measured: 1.5 and 6 months from initiation

  4. PrEP use

    Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period

    Measured: 1.5 and 6 months from initiation

  5. PEP use

    Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period

    Measured: 1.5 and 6 months from initiation

  6. PrEP refill

    Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP

    Measured: 18 months post implementation

  7. Repeat PEP

    Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP

    Measured: 18 months post implementation

  8. PEP-to-PrEP

    Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period

    Measured: 18 months post implementation

  9. Engaged with 1+ product

    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

    Measured: 18 months post implementation

  10. On-demand PrEP use

    Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period

    Measured: 6 months from initiation

  11. PEP-in-Pocket use

    Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period

    Measured: 6 months from initiation

  12. Product choice

    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).

    Measured: 18 months post implementation

  13. PrEP adherence

    Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS

    Measured: 1.5 months from initiation

  14. Reach

    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

    Measured: 18 months post implementation

  15. Efficiency

    Pharmacy-level; continuous outcome: Avg. duration (per visit \& annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration

    Measured: 18 months post implementation

  16. Fidelity

    Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)

    Measured: 1.5 months post initiation

  17. Sustainment

    Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months

    Measured: 24 months post implementation

  18. Acceptability

    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)

    Measured: 24 months post implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07561658
Sponsor's protocol ID
RG1125680
Other IDs
R01MH140465
Status last verified
May 2026
First submitted
24 Apr 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth delivery of pharmacy PrEP/PEP and Standard pharmacy PrEP/PEP delivery in people with HIV, run by Fred Hutchinson Cancer Center at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katrina F Ortblad (206-667-7267, kortblad@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP/PEP initiation (time frame: 18 months post implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07561658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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TelePharm PrEP/PEP (NCT07561658) | AzTrials