HIV Prevention
Conditions
Keywords
pre-exposure prophylaxis, Kenya, pharmacy, HIV self-testing, care pathway, pilot
Brief summary
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
Detailed description
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.
Interventions
OTHERpharmacy-based PrEP delivery
The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.
Sponsors
National Institute of Mental Health (NIMH)
National Institute of Allergy and Infectious Diseases (NIAID)
Bill and Melinda Gates Foundation
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \>=18 years * Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only) * Initiated PrEP at a project-affiliated clinic (Study 1b only) * Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only) * Able & willing to provide written informed consent
Exclusion criteria
* Currently pregnant or breastfeeding (Study 1a & 1b only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation | Over 13-month duration of Study 1a and 6-month duration of Study 2 | Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services. |
| PrEP Retention | Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence | Over 12-month duration of Study 1a and the 6-month duration of Study 2 | Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence |
| STI Testing Uptake | Over 6-month duration of Study 2 | Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies |
| PEP Initiation | Over 6-month duration of Study 2 | Study 2: Number of participants who initiated PEP at a pilot pharmacy. |
| PrEP Initiation Among STI Testing Clients | Over 6-month duration of Study 2 | 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 |
| Selection of Option to Self-administer HIV Risk Assessment Screening Tool | Over 6-month duration of Study 2 | 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) |
| Transition From PEP to PrEP | Over 6-month duration of Study 2 | 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, |
| Selection of Pharmacy-based PrEP Refills | During the 12-month duration of Study 1b | Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy. |
Countries
Kenya
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 287 |
| Study 1b: Pharmacy-based PrEP Delivery 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 in Kenya. | 106 |
| 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. | 823 |
| Total | 1,216 |
Baseline characteristics
| Characteristic | Study 1b: Pharmacy-based PrEP Delivery Refill (12 Months) | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants | 823 Participants | 287 Participants | 1216 Participants |
| Age, Continuous | 31 years | 25 years | 26 years | 26 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Kenya | 106 participants | 823 participants | 287 participants | 1216 participants |
| Sex: Female, Male Female | 63 Participants | 429 Participants | 124 Participants | 616 Participants |
| Sex: Female, Male Male | 43 Participants | 394 Participants | 163 Participants | 600 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 287 | 0 / 106 | 0 / 823 |
| other Total, other adverse events | 0 / 287 | 0 / 106 | 0 / 823 |
| serious Total, serious adverse events | 0 / 287 | 0 / 106 | 0 / 823 |
Outcome results
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.
Time frame: Over 13-month duration of Study 1a and 6-month duration of Study 2
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PrEP Initiation | 287 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Initiation | 661 Participants |
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.
Time frame: Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PrEP Retention | Any PrEP continuation | 153 Participants |
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PrEP Retention | No PrEP continuation | 134 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Retention | No PrEP continuation | 65 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Retention | Any PrEP continuation | 41 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Retention | No PrEP continuation | 185 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Retention | Any PrEP continuation | 476 Participants |
Secondary
PEP Initiation
Study 2: Number of participants who initiated PEP at a pilot pharmacy.
Time frame: Over 6-month duration of Study 2
Population: Study 2: Number of participants who were screened and found preliminarily eligible for PEP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PEP Initiation | 162 Participants |
Secondary
PrEP Adherence
Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence
Time frame: Over 12-month duration of Study 1a and the 6-month duration of Study 2
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PrEP Adherence | 16 Participants |
| Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | PrEP Adherence | 16 Participants |
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
Time frame: Over 6-month duration of Study 2
Population: Phase 2: Number of participants who underwent STI testing at a pilot pharmacy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | PrEP Initiation Among STI Testing Clients | 45 Participants |
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)
Time frame: Over 6-month duration of Study 2
Population: Phase 2: Number of participants who completed screening for PrEP/PEP eligibility.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Selection of Option to Self-administer HIV Risk Assessment Screening Tool | 151 Participants |
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.
Time frame: During the 12-month duration of Study 1b
Population: Study 1b: Number of participants who initiated PrEP at a pilot clinic and were given the option to refill at a pilot pharmacy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Selection of Pharmacy-based PrEP Refills | 3 Participants |
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
Time frame: Over 6-month duration of Study 2
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | STI Testing Uptake | 53 Participants |
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,
Time frame: Over 6-month duration of Study 2
Population: Study 2: Number of participants who initiated and completed PEP regimen at a pilot pharmacy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | Transition From PEP to PrEP | 30 Participants |