Comparison · NCT04558554-725cf432
Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) vs Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months): PrEP Initiation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) vs Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months): PrEP Initiation. Trial comparisons, record NCT04558554-725cf432. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04558554-725cf432
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.499 | 0.458 | 0.54 | wilson | |
| Risk in group 2 | 0.643 | 0.613 | 0.672 | wilson | |
| Risk difference, group 1 minus group 2 | -0.144 | -0.194 | -0.0934 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.776 | 0.707 | 0.853 | log | |
| Odds ratio, group 1 over group 2 | 0.553 | 0.45 | 0.681 | log | |
| Number needed to treat, for one fewer participant with the outcome on Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) than on Study 2: Pharmacy-based PrEP Delivery Pilot Extension (6 Months) | 6.95 | 5.16 | 10.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Study 1a: Pharmacy-based PrEP Delivery Pilot (13 Months) | During Phases 1a and 2, participants in this experimental arm (which includes all participants) will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at retail pharmacies in Kenya. | 287 | 575 | OG000 |
| Group 2 | 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. | 661 | 1,028 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- PrEP Initiation
- Description
- 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.
Source ClinicalTrials.gov
Trial
- Title
- Pharmacy Delivery to Expand the Reach of PrEP in Kenya
- NCT number
- NCT04558554
- Phases
- NA
- Conditions
- HIV Prevention
- Interventions
- pharmacy-based PrEP delivery
- Lead sponsor
- University of Washington
- Results first posted
- 2024-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04558554?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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