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NCT01761643 · ClinicalTrials.gov registry record · Phase 4
CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 398
- Enrollment target
NCT01761643: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT01761643 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 398 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01761643, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 398 participants
- Enrollment target
Study Summary
CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.
Primary Outcome
Proportion of participants adherent to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations \> 719 fmol/punch at Week 12 and the last on-drug visit.
Interventions
- DEVICE SoC + iTab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2012-12-19 |
| Est. Completion | 2018-07-11 |
| Phase | Phase 4 |
What the finished NCT01761643 record still lists
NCT01761643 is an interventional study that assigns participants to a tested intervention. The registered 398 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which SoC + iTab is the first listed.
NCT01761643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01761643 about?
NCT01761643 is a clinical study titled "CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM". CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.
What is the current status of trial NCT01761643?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 398 participants. The study started on 2012-12-19. Estimated completion is 2018-07-11.
What interventions are being tested in trial NCT01761643?
The interventions under investigation include: SoC + iTab (DEVICE).
Who is sponsoring clinical trial NCT01761643?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01761643's enrollment target sits among peer trials
398 217th of 2000 higher than 1,783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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