Skip to main content
OpenTrials
Completed

NCT Number: NCT05842122

Pharmacy-based PrEP Delivery in Kenya

A cluster-randomized control trial (cRCT) testing different cost-sharing models for the delivery of HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya. The goal is to assess the effect of different pharmacy-based PrEP/PEP service delivery models on PrEP/PEP initiation and continuation outcomes, compared to pharmacy referral to clinic-based PrEP/PEP services (i.e., what is currently allowed in Kenya at the moment without any changes to policies or guidelines). In the cRCT, 60 pharmacies across Central and Western Kenya will be randomized to one of 4 study arms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute, Kisumu, Kenya

Loading trial locations.

About this study

Participating study pharmacies will be 1:1:1:1 randomized to either: 1) client-sustained delivery of pharmacy PrEP/PEP services (clients pay 250 KES/visit; study team compensates pharmacies 0 KES/visit); implementor-sustained delivery of pharmacy PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 250 KES/visit); 3) Counselor-supported delivery of pharmacy PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit); or 4) referral to existing clinic-based PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit). The primary cRCT outcomes are PrEP initiation and continuation, assessed 60 days following clients first pharmacy PrEP/PEP visit/referral. We will implement the trial for up to 16 months, or longer, depending on achievement of our primary study objectives.

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
  • Must be willing to use a study-specific module within a digital platform (Maisha Meds) to record pharmacy PrEP/PEP dispensing
  • Owner must agree to allow a trained research assistant to come to the pharmacy on select days to collect data from a random subset of participants
  • Owner must agree to allow providers to participate in a monitored WhatsApp group, optional surveys, and optional in-depth interview
  • Owner must agree to allow providers to routinely engage with a technical assistant

Pharmacists/HTS counselors

  • ≥ 18 years old
  • Licensed pharmacist, licensed pharmaceutical technologist, or NASCOP-certified HTS counselor
  • Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
  • Completed training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
  • Able and willing to provide informed consent
  • Complete study training
  • Willing to use a study-specific module within a digital platform (Maisha Meds) to document PrEP/PEP services rendered

Clients

  • ≥ 16 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 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

Client-sustained delivery of pharmacy PrEP/PEP

Behavioral
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 250 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 0 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)

Implementor-sustained delivery of pharmacy PrEP/PEP

Behavioral
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 0 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 250 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)

Counselor-supported delivery of pharmacy PrEP/PEP

Behavioral
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible.
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery with support from a HTS counselor (to assist with screening and HIV testing)
  • Cost to client: 0 KES per pharmacy PrEP/PEP visit
  • Payment to pharmacy:* 100 KES per pharmacy PrEP/PEP visit *Pharmacies paid by the research team (i.e., the "implementer" in this trial)

Referral to clinic-based PrEP/PEP

Behavioral
  • Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) referral to clinic-based PrEP/PEP services
  • Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery
  • Cost to client: 0 KES per pharmacy PrEP/PEP referral
  • Payment to pharmacy:* 100 KES per pharmacy PrEP/PEP referral *Pharmacies paid by the research team (i.e., the "implementer" in this trial)

Primary outcomes

  1. PrEP initiation

    Time frame: 60 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) PrEP at the pharmacy or clinic within 60 days of initial pharmacy-based screening.

    Comparisons between intervention arms and the control will rely on self-report from the 60-day client survey, while comparisons between intervention arms will employ pharmacy records.

  2. PrEP continuation

    Time frame: 60 days

    The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and returned to the pharmacy or clinic and refilled PrEP within 60 days of initial pharmacy-based screening.

    Comparisons between intervention arms and the control will rely on self-report from the 60-day client survey, while comparisons between intervention arms will employ pharmacy records.

Secondary outcomes

  1. PrEP initiation - 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) PrEP at the pharmacy or clinic within 270 days of initial pharmacy-based screening

  2. PrEP continuation - 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and returned to the pharmacy or clinic and refilled PrEP within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage)

  3. PrEP continuation - refilled at least twice 270 days

    Time frame: 60 days

    The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and refilled PrEP at least twice within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage).

  4. PrEP continuation - any stopping/restarting 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and refilled PrEP more than 7 days after their expected refill date (i.e., stopping and restarting, also referred to as "PrEP reinitiation") within 270 days of initial pharmacy-based screening.

  5. PrEP adherence

    Time frame: 60 days

    The median adherence score (0-100) among participants at each pharmacy who initiated PrEP at the pharmacy or clinic -using the Wilson et al. scale (2020, AIDS)-as measured at 60 days following initial pharmacy screening.

  6. PEP initiation

    Time frame: 60 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) PEP ≥1 times at the pharmacy or clinic within 3 days, as measured at 60 days following initial pharmacy screening.

  7. PEP initiation - 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) PEP ≥1 times at the pharmacy or clinic within 3 days, as measured at 270 days following initial pharmacy screening.

  8. PEP-to-PrEP transition

    Time frame: 60 days

    The number of participants at each pharmacy that successfully completed PEP (tested negative or self-reported testing negative for HIV between 28 and 45 days after initiating PEP at the pharmacy) and initiated PrEP at the pharmacy or clinic as measured at 60 days following initial pharmacy screening.

  9. PEP-to-PrEP transition - 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that successfully completed PEP (tested negative or self-reported testing negative for HIV between 28 and 45 days after initiating PEP at the pharmacy) and initiated PrEP at the pharmacy or clinic as measured at 270 days following initial pharmacy screening.

  10. PrEP-to-PEP transition

    Time frame: 60 days

    The number of participants at each pharmacy that initiated (i.e. were dispensed) PrEP and subsequently initiated PEP at the pharmacy or clinic within 3 days, as measured at 60 days following initial pharmacy screening.

  11. PrEP-to-PEP transition - 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated (i.e. were dispensed) PrEP and subsequently initiated PEP at the pharmacy or clinic within 3 days, as measured at 270 days following initial pharmacy screening.

  12. PrEP/PEP initiation

    Time frame: 60 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) either PEP or PrEP at the pharmacy or clinic (within 3 days for PEP clients) as measured at 60 days following initial pharmacy screening.

  13. PrEP/PEP initiation- 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that initiated (i.e., were dispensed) either PEP or PrEP at the pharmacy or clinic (within 3 days for PEP clients) as measured at 270 days following initial pharmacy screening.

  14. PrEP/PEP continuation

    Time frame: 60 days

    The number of participants at each pharmacy that (1) initiated PrEP and refilled PrEP or later were dispensed PEP; or (2) initiated PEP and transitioned to PrEP or later were dispensed PEP again as measured at 60 days of initial pharmacy screening.

  15. PrEP/PEP continuation- 270 days

    Time frame: 270 days

    The number of participants at each pharmacy that (1) initiated PrEP and refilled PrEP or later were dispensed PEP; or (2) initiated PEP and transitioned to PrEP or later were dispensed PEP again as measured at 270 days of initial pharmacy screening.

  16. Recurrent PEP use

    Time frame: 60 days

    The number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 60 days and 270 days of initial pharmacy screening.

  17. Recurrent PEP use- 270 days

    Time frame: 270 days

    the number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 270 days of initial pharmacy screening.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Jhpiego
  • Kenya Medical Research Institute

Registry information

Official study title

Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Mar 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.