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NCT Number: NCT07561658

TelePharm PrEP/PEP

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.

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Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Kisumu, Kenya

Location contact

Elizabeth A Bukusi

CONTACT

[email protected]

+254-572021036

Elizabeth A Bukusi

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth delivery of pharmacy PrEP/PEP

Other

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 delivery

Other

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

Primary outcomes

  1. PrEP/PEP initiation

    Time frame: 18 months post implementation

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

  2. PrEP/PEP continuation

    Time frame: 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

Secondary outcomes

  1. PrEP initiation

    Time frame: 18 months post implementation

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

  2. PEP initiation

    Time frame: 18 months post implementation

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

  3. PrEP/PEP use

    Time frame: 1.5 and 6 months from initiation

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

  4. PrEP use

    Time frame: 1.5 and 6 months from initiation

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

  5. PEP use

    Time frame: 1.5 and 6 months from initiation

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

  6. PrEP refill

    Time frame: 18 months post implementation

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

  7. Repeat PEP

    Time frame: 18 months post implementation

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

  8. PEP-to-PrEP

    Time frame: 18 months post implementation

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

  9. Engaged with 1+ product

    Time frame: 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

  10. On-demand PrEP use

    Time frame: 6 months from initiation

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

  11. PEP-in-Pocket use

    Time frame: 6 months from initiation

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

  12. Product choice

    Time frame: 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).

  13. PrEP adherence

    Time frame: 1.5 months from initiation

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

  14. Reach

    Time frame: 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

  15. Efficiency

    Time frame: 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

  16. Fidelity

    Time frame: 1.5 months post initiation

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

  17. Sustainment

    Time frame: 24 months post implementation

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

  18. Acceptability

    Time frame: 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)

Other outcomes

  1. Time to use (for on-demand PrEP) at 1.5 months

    Time frame: 1.5 months

    Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients

  2. Time to use (for on-demand PrEP) at 6 months

    Time frame: 6 months

    Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients

  3. STI diagnosis

    Time frame: 18 months post implementation

    Individual-level; binary outcome: % of PrEP/PEP clients with a syndromic STI diagnosis (at any pharmacy PrEP/PEP visit)

  4. Other drugs dispensed

    Time frame: 18 months post implementation

    Pharmacy-level; binary outcome: % of PrEP/PEP clients dispensed other drugs (e.g., hypertension, contraception) at their visit

  5. HIV incidence

    Time frame: 18 months

    Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive

  6. HIV risk

    Time frame: 18 months post implementation

    Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)

Study contacts

Contact information is provided by the study sponsor or research team.

Katrina F Ortblad

CONTACT

[email protected]

206-667-7267

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 1, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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