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| ID | Type | Description | Link |
|---|---|---|---|
| BMGF INV-033052 | Other Grant/Funding Number | Bill & Melinda Gates Foundation | |
| 11136 | Other Identifier | Fred Hutchinson Cancer Center IRB |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Jhpiego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Client-sustained delivery of pharmacy PrEP/PEP | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 270 days |
| PrEP continuation - 270 days |
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Inclusion Criteria:
Pharmacies
Pharmacists/HTS counselors
Clients
Exclusion Criteria:
Clients
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Malen, MPH | Fred Hutch Cancer Center | Study Chair |
| Kendall Harkey, MPH | Fred Hutch Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Kisumu | Kenya | ||||
| Partners in Health & Research Development |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41466427 | Derived | 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. | |
| 40195998 |
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Deidentified data may be available upon request at the discretion of the study PI (Ortblad).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2025 | Mar 24, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2023 | Aug 6, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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).
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| Implementor-sustained delivery of pharmacy PrEP/PEP | Behavioral |
|
|
| Counselor-supported delivery of pharmacy PrEP/PEP | Behavioral |
|
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| Referral to clinic-based PrEP/PEP | Behavioral |
|
|
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)
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 270 days |
| Thika |
| Kenya |
| Derived |
| Kareithi 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |