Trial Outcomes & Findings for Pharmacy Delivery to Expand the Reach of PrEP in Kenya (NCT NCT04558554)
NCT ID: NCT04558554
Last Updated: 2024-03-15
Results Overview
Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.
COMPLETED
NA
1216 participants
Over 13-month duration of Study 1a and 6-month duration of Study 2
2024-03-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
287
|
106
|
823
|
|
Overall Study
COMPLETED
|
287
|
106
|
823
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months)
n=287 Participants
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)
n=106 Participants
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.
|
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
n=823 Participants
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.
|
Total
n=1216 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=287 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=823 Participants
|
0 Participants
n=1216 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
287 Participants
n=287 Participants
|
106 Participants
n=106 Participants
|
823 Participants
n=823 Participants
|
1216 Participants
n=1216 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=287 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=823 Participants
|
0 Participants
n=1216 Participants
|
|
Age, Continuous
|
26 years
n=287 Participants
|
31 years
n=106 Participants
|
25 years
n=823 Participants
|
26 years
n=1216 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=287 Participants
|
63 Participants
n=106 Participants
|
429 Participants
n=823 Participants
|
616 Participants
n=1216 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=287 Participants
|
43 Participants
n=106 Participants
|
394 Participants
n=823 Participants
|
600 Participants
n=1216 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Kenya
|
287 participants
n=287 Participants
|
106 participants
n=106 Participants
|
823 participants
n=823 Participants
|
1216 participants
n=1216 Participants
|
PRIMARY outcome
Timeframe: Over 13-month duration of Study 1a and 6-month duration of Study 2Population: 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.
Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=575 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
n=1028 Participants
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.
|
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.
|
|---|---|---|---|
|
PrEP Initiation
|
287 Participants
|
661 Participants
|
—
|
PRIMARY outcome
Timeframe: Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2Population: 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.
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.
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=287 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
n=106 Participants
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.
|
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
n=661 Participants
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.
|
|---|---|---|---|
|
PrEP Retention
Any PrEP continuation
|
153 Participants
|
41 Participants
|
476 Participants
|
|
PrEP Retention
No PrEP continuation
|
134 Participants
|
65 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: Over 6-month duration of Study 2Population: Study 2: Number of participants who were screened and found preliminarily eligible for PEP.
Study 2: Number of participants who initiated PEP at a pilot pharmacy.
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=192 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
PEP Initiation
|
162 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-month duration of Study 1bPopulation: Study 1b: Number of participants who initiated PrEP at a pilot clinic and were given the option to refill at a pilot pharmacy.
Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy.
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=106 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
Selection of Pharmacy-based PrEP Refills
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Over 12-month duration of Study 1a and the 6-month duration of Study 2Population: 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.
Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=61 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
n=48 Participants
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.
|
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.
|
|---|---|---|---|
|
PrEP Adherence
|
16 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Over 6-month duration of Study 2Population: 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)
Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=64 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
STI Testing Uptake
|
53 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Over 6-month duration of Study 2Population: Study 2: Number of participants who initiated and completed PEP regimen at a pilot pharmacy
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,
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=162 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
Transition From PEP to PrEP
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Over 6-month duration of Study 2Population: Phase 2: Number of participants who underwent STI testing at a pilot pharmacy.
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
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=53 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
PrEP Initiation Among STI Testing Clients
|
45 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Over 6-month duration of Study 2Population: Phase 2: Number of participants who completed screening for PrEP/PEP eligibility.
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)
Outcome measures
| Measure |
Study 1a: Pharmacy-based PrEP Delivery (13 Months)
n=823 Participants
Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.
|
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.
|
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.
|
|---|---|---|---|
|
Selection of Option to Self-administer HIV Risk Assessment Screening Tool
|
151 Participants
|
—
|
—
|
Adverse Events
Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months)
Study 1b: Pharmacy-based PrEP Refill (12 Months)
Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place