HivNCT05842122
Pharmacy-based PrEP Delivery in Kenya
A study testing Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP and Counselor-supported delivery of pharmacy PrEP/PEP in people with Hiv, run by Fred Hutchinson Cancer Center at 2 sites in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP and Counselor-supported delivery of pharmacy PrEP/PEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,808 participants
- Where
- 2 sitesKenya
- Study dates
- 20 Jun 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 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
- 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
Show all 21Show fewer
- 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
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
2 sites in 1 country.
Kenya2 sites
Kenya Medical Research Institute
Kisumu
Partners in Health & Research Development
Thika
About this study
Official title: Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Hiv
- Being tested
- Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP, Counselor-supported delivery of pharmacy PrEP/PEP, Referral to clinic-based PrEP/PEP
- Keywords
- Kenya, HIV pre-exposure prophylaxis (PrEP) delivery, PEP, Pharmacy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Client-sustained delivery of pharmacy PrEP/PEPBehavioural
- 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/PEPBehavioural
- 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/PEPBehavioural
- 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/PEPBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Client-sustained delivery of pharmacy PrEP/PEP | Active comparator | Pharmacy providers offer clients PrEP and PEP services for a fee of 250 Kenyan Shillings (KES) per visit (study team compensates pharmacy providers 0 KES per visit). Receives: Behavioral: Client-sustained delivery of pharmacy PrEP/PEP |
| Implementor-sustained delivery of pharmacy PrEP/PEP | Active comparator | Pharmacy providers offer clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 250 KES per visit). Receives: Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEP |
| Counselor-supported delivery of pharmacy PrEP/PEP | Active comparator | HIV testing service (HTS) counselors support pharmacy providers in offering clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 100 KES per visit). Receives: Behavioral: Counselor-supported delivery of pharmacy PrEP/PEP |
| Referral to clinic-based PrEP/PEP | Active comparator | Pharmacy providers offer clients referral to PrEP and PEP services at nearby public clinics for a fee of 0 KES per referral (study team compensates pharmacy providers 100 KES per referral). Receives: Behavioral: Referral to clinic-based PrEP/PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation
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.
Measured: 60 days
PrEP continuation
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.
Measured: 60 days
Secondary outcomes (17)
PrEP initiation - 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
Measured: 270 days
PrEP continuation - 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)
Measured: 270 days
PrEP continuation - refilled at least twice 270 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).
Measured: 60 days
PrEP continuation - any stopping/restarting 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.
Measured: 270 days
PrEP adherence
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.
Measured: 60 days
PEP initiation
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.
Measured: 60 days
PEP initiation - 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.
Measured: 270 days
PEP-to-PrEP transition
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.
Measured: 60 days
PEP-to-PrEP transition - 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.
Measured: 270 days
PrEP-to-PEP transition
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.
Measured: 60 days
PrEP-to-PEP transition - 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.
Measured: 270 days
PrEP/PEP initiation
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.
Measured: 60 days
PrEP/PEP initiation- 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.
Measured: 270 days
PrEP/PEP continuation
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.
Measured: 60 days
PrEP/PEP continuation- 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.
Measured: 270 days
Recurrent PEP use
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.
Measured: 60 days
Recurrent PEP use- 270 days
the number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 270 days of initial pharmacy screening.
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Jun 2023
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- In the cluster-randomized control trial, the intervention will be introduced in a parallel fashion (i.e., all pharmacies assigned a given intervention will receive the intervention at the start of the trial).
- Masking
- None (open label)
- Enrolment
- 5,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jhpiego
- Responsible party
- Principal investigator, Katrina Ortblad, Fred Hutchinson Cancer Center
- Investigators
- Rachel Malen, MPH, Study chair, Fred Hutch Cancer CenterKendall Harkey, MPH, Study chair, Fred Hutch Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842122
- Sponsor's protocol ID
- RG1123165
- Other IDs
- BMGF INV-033052, 11136
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be available upon request at the discretion of the study PI (Ortblad).
Publications
Kareithi T, Roche SD, Meisner A, Omollo V, Ong'wen PA, Harkey K, Kiptinness C, Otieno P, Juma L, Malen RC, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi ML, Shah PD, Sharma M, Were D, Ngure K, Bukusi EA, Ortblad KF; Pharm PrEP cRCT team. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Trials. 2025 Dec 30;27(1):95. doi: 10.1186/s13063-025-09384-7.
PubMed 41466427Kareithi T, D Roche S, Omollo V, Ong'wen PA, Kiptinness C, Otieno P, Juma L, Malen RC, Harkey K, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi M, Shah PD, Sharma M, Meisner A, Were D, Ngure K, Bukusi EA, Ortblad KF. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2025 Mar 27:rs.3.rs-5968938. doi: 10.21203/rs.3.rs-5968938/v1.
PubMed 40195998
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
- ClinicalTrials.gov ID
- NCT05842122
- Acronym / sponsor ID
- RG1123165
- Conditions
- Hiv
- Keywords
- Kenya, HIV pre-exposure prophylaxis (PrEP) delivery, PEP, Pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,808 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jhpiego
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In the cluster-randomized control trial, the intervention will be introduced in a parallel fashion (i.e., all pharmacies assigned a given intervention will receive the intervention at the start of the trial).
| Arm | Type | Receives |
|---|---|---|
| Client-sustained delivery of pharmacy PrEP/PEP | Active comparator | Behavioral: Client-sustained delivery of pharmacy PrEP/PEPPharmacy providers offer clients PrEP and PEP services for a fee of 250 Kenyan Shillings (KES) per visit (study team compensates pharmacy providers 0 KES per visit). |
| Implementor-sustained delivery of pharmacy PrEP/PEP | Active comparator | Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEPPharmacy providers offer clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 250 KES per visit). |
| Counselor-supported delivery of pharmacy PrEP/PEP | Active comparator | Behavioral: Counselor-supported delivery of pharmacy PrEP/PEPHIV testing service (HTS) counselors support pharmacy providers in offering clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 100 KES per visit). |
| Referral to clinic-based PrEP/PEP | Active comparator | Behavioral: Referral to clinic-based PrEP/PEPPharmacy providers offer clients referral to PrEP and PEP services at nearby public clinics for a fee of 0 KES per referral (study team compensates pharmacy providers 100 KES per referral). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Client-sustained delivery of pharmacy PrEP/PEP* 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) | Behavioural | Client-sustained delivery of pharmacy PrEP/PEP |
| Implementor-sustained delivery of pharmacy PrEP/PEP* 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) | Behavioural | Implementor-sustained delivery of pharmacy PrEP/PEP |
| Counselor-supported delivery of pharmacy PrEP/PEP* 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) | Behavioural | Counselor-supported delivery of pharmacy PrEP/PEP |
| Referral to clinic-based PrEP/PEP* 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) | Behavioural | Referral to clinic-based PrEP/PEP |
Primary outcome
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.
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.
17 secondary outcomes
PrEP initiation - 270 days
Time frame: 270 days
PrEP continuation - 270 days
Time frame: 270 days
PrEP continuation - refilled at least twice 270 days
Time frame: 60 days
PrEP continuation - any stopping/restarting 270 days
Time frame: 270 days
PrEP adherence
Time frame: 60 days
PEP initiation
Time frame: 60 days
PEP initiation - 270 days
Time frame: 270 days
PEP-to-PrEP transition
Time frame: 60 days
PEP-to-PrEP transition - 270 days
Time frame: 270 days
PrEP-to-PEP transition
Time frame: 60 days
PrEP-to-PEP transition - 270 days
Time frame: 270 days
PrEP/PEP initiation
Time frame: 60 days
PrEP/PEP initiation- 270 days
Time frame: 270 days
PrEP/PEP continuation
Time frame: 60 days
PrEP/PEP continuation- 270 days
Time frame: 270 days
Recurrent PEP use
Time frame: 60 days
Recurrent PEP use- 270 days
Time frame: 270 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 41466427Kareithi T, Roche SD, Meisner A, Omollo V, Ong'wen PA, Harkey K, Kiptinness C, Otieno P, Juma L, Malen RC, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi ML, Shah PD, Sharma M, Were D, Ngure K, Bukusi EA, Ortblad KF; Pharm PrEP cRCT team. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Trials. 2025 Dec 30;27(1):95. doi: 10.1186/s13063-025-09384-7.
- Derived from this study: PubMed 40195998Kareithi T, D Roche S, Omollo V, Ong'wen PA, Kiptinness C, Otieno P, Juma L, Malen RC, Harkey K, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi M, Shah PD, Sharma M, Meisner A, Were D, Ngure K, Bukusi EA, Ortblad KF. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2025 Mar 27:rs.3.rs-5968938. doi: 10.21203/rs.3.rs-5968938/v1.
- Individual participant dataSharing planned: No. Deidentified data may be available upon request at the discretion of the study PI (Ortblad).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Malen, MPH study chair
Fred Hutch Cancer Center
Kendall Harkey, MPH study chair
Fred Hutch Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP and Counselor-supported delivery of pharmacy PrEP/PEP in people with Hiv, run by Fred Hutchinson Cancer Center at 2 sites 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 21 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (time frame: 60 days). 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 NCT05842122, which also lists 2 linked publications.
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 27 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.