Trial · NCT04558554
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
NCT04558554, Not applicable, Completed, University of Washington; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pharmacy Delivery to Expand the Reach of PrEP in Kenya. Trials, record NCT04558554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04558554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacy Delivery to Expand the Reach of PrEP in Kenya
- NCT number
- NCT04558554
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,216 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- HIV Prevention
- Interventions
- pharmacy-based PrEP delivery
- First posted
- 2020-09-22
- Last updated
- 2024-03-15
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | PEP Initiation | Over 6-month duration of Study 2 | Study 2: Number of participants who initiated PEP at a pilot pharmacy. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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, |
| Secondary | 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 |
| Secondary | 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) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PrEP Initiation | Over 13-month duration of Study 1a and 6-month duration of Study 2 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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: 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PEP Initiation | Over 6-month duration of Study 2 | Study 2: Number of participants who were screened and found preliminarily eligible for PEP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Selection of Pharmacy-based PrEP Refills | During the 12-month duration of Study 1b | Study 1b: Number of participants who initiated PrEP at a pilot clinic and were given the option to refill at a pilot pharmacy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PrEP Adherence | Over 12-month duration of Study 1a and the 6-month duration of Study 2 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | STI Testing Uptake | Over 6-month duration of Study 2 | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transition From PEP to PrEP | Over 6-month duration of Study 2 | Study 2: Number of participants who initiated and completed PEP regimen at a pilot pharmacy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PrEP Initiation Among STI Testing Clients | Over 6-month duration of Study 2 | Phase 2: Number of participants who underwent STI testing at a pilot pharmacy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Selection of Option to Self-administer HIV Risk Assessment Screening Tool | Over 6-month duration of Study 2 | Phase 2: Number of participants who completed screening for PrEP/PEP eligibility. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PrEP Initiation | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 287 | Participants | ||
| PrEP Initiation | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 661 | Participants | ||
| PrEP Retention | Study 1a: Pharmacy-based PrEP Delivery (13 Months) | Any PrEP continuation | 153 | Participants | |
| PrEP Retention | Study 1b: Pharmacy-based PrEP Refill (12 Months) | Any PrEP continuation | 41 | Participants | |
| PrEP Retention | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | Any PrEP continuation | 476 | Participants | |
| PrEP Retention | Study 1a: Pharmacy-based PrEP Delivery (13 Months) | No PrEP continuation | 134 | Participants | |
| PrEP Retention | Study 1b: Pharmacy-based PrEP Refill (12 Months) | No PrEP continuation | 65 | Participants | |
| PrEP Retention | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | No PrEP continuation | 185 | Participants | |
| PEP Initiation | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 162 | Participants | ||
| Selection of Pharmacy-based PrEP Refills | Study 1b: Pharmacy-based PrEP Delivery Refill (12 Months) | 3 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 287 | |
| Overall Study | STARTED | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 106 | |
| Overall Study | STARTED | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 823 | |
| Overall Study | COMPLETED | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 287 | |
| Overall Study | COMPLETED | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 106 | |
| Overall Study | COMPLETED | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 823 | |
| Overall Study | NOT COMPLETED | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 0 | |
| Overall Study | NOT COMPLETED | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 0 | |
| Overall Study | NOT COMPLETED | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 0 | 287 |
| Total, all-cause mortality | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 0 | 106 |
| Total, all-cause mortality | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 0 | 823 |
| Total, other adverse events | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 0 | 287 |
| Total, other adverse events | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 0 | 106 |
| Total, other adverse events | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 0 | 823 |
| Total, serious adverse events | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | 0 | 287 |
| Total, serious adverse events | Study 1b: Pharmacy-based PrEP Refill (12 Months) | 0 | 106 |
| Total, serious adverse events | Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 0 | 823 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30AI027757 | University of Washington/Fred Hutch Center for AIDS Research | CELUM, CONNIE L | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 1988 to 2025 | NIH RePORTER |
| R34MH120106 | Pharmacy delivery to expand the reach of PrEP in Kenya | ORTBLAD, KATRINA FRANCES | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF MENTAL HEALTH | 2019 to 2020 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) vs Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months): PrEP Initiation | Trial comparisons |
| Study 1a: Pharmacy-based PrEP Delivery (13 Months) vs Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months): PrEP Adherence | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04558554
GET https://conductscience.org/api/trials/v1/NCT04558554/registered