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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH120106 | U.S. NIH Grant/Contract | View source | |
| P30AI027757 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Bill and Melinda Gates Foundation | OTHER |
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3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers' unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP - including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills - are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. Prior formative qualitative research and a stakeholder meeting led to development of a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We will conduct 3 separate, consecutive studies.
During Study 1a (13 months), we will pilot this care pathway in 2 retail pharmacies evenly split between 2 different geographies in Kenya: Kisumu and Thika. Activities will include data collection aimed at potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.
During Study 1b (12 months, happening concurrently with Study 1a), we will additionally offer pharmacy-based PrEP refills only to clients who initiated PrEP at select public health clinics, to assess how many clients opt to refill PrEP at a study pharmacy (for a fee) as opposed to at the clinic (for free).
During Study 2 (6 months, happening right after Study 1a), we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Study 1a, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1a: Pharmacy-based PrEP delivery Pilot (13 months) | Experimental | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya. |
|
| Study 1b: Pharmacy-based PrEP delivery Refill (12 months) | Experimental | Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics. |
|
| Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months) | Experimental | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacy-based PrEP delivery | Other | The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Initiation | Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services. | Over 13-month duration of Study 1a and 6-month duration of Study 2 |
| PrEP Retention | For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy. Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic. | Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2 |
| Measure | Description | Time Frame |
|---|---|---|
| PEP Initiation | Study 2: Number of participants who initiated PEP at a pilot pharmacy. | Over 6-month duration of Study 2 |
| Selection of Pharmacy-based PrEP Refills | Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrina Ortblad, MPH, ScD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Kisumu | Kenya | ||||
| Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38730398 | Derived | Ortblad KF, Kuo AP, Mogere P, Roche SD, Kiptinness C, Wairimu N, Gakuo S, Baeten JM, Ngure K. Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya. BMC Health Serv Res. 2024 May 11;24(1):618. doi: 10.1186/s12913-024-10995-0. | |
| 37306128 | Derived | Ortblad KF, Mogere P, Omollo V, Kuo AP, Asewe M, Gakuo S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi EA, Ngure K, Baeten JM. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 2023 Jun;26(6):e26131. doi: 10.1002/jia2.26131. |
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Pharmacists recruited participants by hanging up promotional posters encouraging clients to ask about PrEP (or PEP, in Study 2 only) for HIV prevention. They also offered to screen clients who were purchasing products indicative of sexual activity and potential HIV exposure (e.g., emergency contraception, pregnancy testing, STI treatment). Participants in Study 1a & b were recruited from Nov.2020-Dec. 2021 and in Study 2 from Jan.-Jul. 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies. |
| FG001 | Study 1b: Pharmacy-based PrEP Refill (12 Months) | Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies after having initiated PrEP at one of 2 public clinics. |
| FG002 | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Cumulative number of participants who, across Study 1a, 1b, and 2, consented and initiated PrEP or PEP at a study pharmacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya. |
| BG001 | Study 1b: Pharmacy-based PrEP Delivery Refill (12 Months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PrEP Initiation | Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services. | Participants eligible for pharmacy PrEP among those screened. PLEASE NOTE: Prospective study participants were screened for preliminary eligibility for PrEP before they were enrolled in the study. Across Study 1a and 2, 1603 clients were screened and found eligible for PrEP; however, not all of these clients decided to enroll in the study. That is why this number exceeds the number who started the study (n=1216) reported in other sections of this record. | Posted | Count of Participants | Participants | Over 13-month duration of Study 1a and 6-month duration of Study 2 |
|
Phase 1a: 13 months Phase 1b (concurrent with Phase 1a): 12 months Phase 2: 6 months Total duration from start of Phase 1a (Nov. 2020) to completion of Phase 2 (July 2022): 20 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrina Ortblad | Fred Hutchinson Cancer Center | 206.667.7267 | kortblad@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2022 | Jul 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2022 | Jul 18, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2022 | Jul 18, 2023 | ICF_002.pdf |
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During Studies 1a, 1b, and 2, all individuals meeting study and PrEP eligibility criteria will have the option Study 2, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Study 2, a subset of four study pharmacies (2 per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
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| During the 12-month duration of Study 1b |
| PrEP Adherence | Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence | Over 12-month duration of Study 1a and the 6-month duration of Study 2 |
| STI Testing Uptake | Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies | Over 6-month duration of Study 2 |
| Transition From PEP to PrEP | Study 2: Percentage of participants who completed the full PEP regimen and subsequently initiated PrEP at a pilot pharmacy, among those who initiated PEP at a pilot pharmacy, | Over 6-month duration of Study 2 |
| PrEP Initiation Among STI Testing Clients | Study 2: Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit | Over 6-month duration of Study 2 |
| Selection of Option to Self-administer HIV Risk Assessment Screening Tool | Study 2: Number of participants who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it) | Over 6-month duration of Study 2 |
| Thika |
| Kenya |
| 37079900 | Derived | Omollo V, Asewe M, Mogere P, Maina G, Kuo AP, Odoyo J, Oware K, Baeten JM, Kohler P, Owens T, Bukusi EA, Ngure K, Ortblad KF. The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya. J Acquir Immune Defic Syndr. 2023 Aug 15;93(5):379-386. doi: 10.1097/QAI.0000000000003208. |
Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies after having initiated PrEP at one of 2 public clinics in Kenya. |
| BG002 | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. |
|
|
| Primary | PrEP Retention | For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy. Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic. | For Study 1a and 2: Number of participants who initiated PrEP at a pilot pharmacy. Study 1b: Number of participants who initiated PrEP at a pilot clinic. PLEASE NOTE: This denominator (n=1054) exceeds the number of clients reported as having initiated PrEP for our primary outcome measure of "PrEP initiation" (n=948) because it includes 106 clients who, as part of Study 1b, had initiated PrEP at a pilot clinic. | Posted | Count of Participants | Participants | Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2 |
|
|
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| Secondary | PEP Initiation | Study 2: Number of participants who initiated PEP at a pilot pharmacy. | Study 2: Number of participants who were screened and found preliminarily eligible for PEP. | Posted | Count of Participants | Participants | Over 6-month duration of Study 2 |
|
|
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| Secondary | Selection of Pharmacy-based PrEP Refills | Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy. | Study 1b: Number of participants who initiated PrEP at a pilot clinic and were given the option to refill at a pilot pharmacy. | Posted | Count of Participants | Participants | During the 12-month duration of Study 1b |
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| Secondary | PrEP Adherence | Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence | Study 1a and Study 2: Number of DBS samples randomly selected for drug concentration testing. Note: DBS samples were only collected from participants who had initiated PrEP at a pilot pharmacy. | Posted | Count of Participants | Participants | Over 12-month duration of Study 1a and the 6-month duration of Study 2 |
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| Secondary | STI Testing Uptake | Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies | Study 2: Number of participants who were screened and found potentially eligible for STI testing (providing a urine sample for lab-based testing) at pilot pharmacies. NOTE: STI testing was only offered at a sub-section of study pharmacies (n=4) | Posted | Count of Participants | Participants | Over 6-month duration of Study 2 |
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| Secondary | Transition From PEP to PrEP | Study 2: Percentage of participants who completed the full PEP regimen and subsequently initiated PrEP at a pilot pharmacy, among those who initiated PEP at a pilot pharmacy, | Study 2: Number of participants who initiated and completed PEP regimen at a pilot pharmacy | Posted | Count of Participants | Participants | Over 6-month duration of Study 2 |
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| Secondary | PrEP Initiation Among STI Testing Clients | Study 2: Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit | Phase 2: Number of participants who underwent STI testing at a pilot pharmacy. | Posted | Count of Participants | Participants | Over 6-month duration of Study 2 |
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| Secondary | Selection of Option to Self-administer HIV Risk Assessment Screening Tool | Study 2: Number of participants who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it) | Phase 2: Number of participants who completed screening for PrEP/PEP eligibility. | Posted | Count of Participants | Participants | Over 6-month duration of Study 2 |
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| 0 |
| 287 |
| 0 |
| 287 |
| 0 |
| 287 |
| EG001 | Study 1b: Pharmacy-based PrEP Refill (12 Months) | Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics. | 0 | 106 | 0 | 106 | 0 | 106 |
| EG002 | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. | 0 | 823 | 0 | 823 | 0 | 823 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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