Trial · NCT07884240
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Composite Incident STI events | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Nucleic acid amplification test (NAAT) from all sites (vaginal, rectal, oropharyngeal) or newly positive or four-fold rise in RPR titers |
| Secondary | The Rate of Incident Chlamydia Trachomatis (CT) Infection | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Nucleic Acid Amplification Test (NAAT) From All Sites (vaginal, rectal, oropharyngeal) |
| Secondary | The Rate of Incident Neisseria Gonorrhoeae (NG) Infection | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Nucleic Acid Amplification Test (NAAT) From All Sites (vaginal, rectal, oropharyngeal) |
| Secondary | The Rate of Incident Early Syphilis Infection | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Newly Positive or Four-Fold Rise in Rapid Plasma Reagin (RPR) Titers From All Sites (vaginal, rectal, oropharyngeal) |
| Secondary | The Rate of Incident NG Infection | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Nucleic Acid Amplification Test (NAAT) From Rectal or Pharyngeal Site |
| Secondary | The Rate of Incident CT Infection | Testing will occur at each quarterly visit (week 13, 26, 39 and 52). | Nucleic Acid Amplification Test (NAAT) From Rectal or Pharyngeal Site |
| Secondary | The Number of Doxycycline-specific Side Effects | Week 0 through Week 52 | Such as gastrointestinal upset, photosensitivity, esophageal irritation, and skin reactions |
| Secondary | The Number of Participants who discontinue study due to side effects | Week 0 through Week 52 | |
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Week 0 through Week 52 | |
| Secondary | Number of Participants with Adverse Events (AEs) | Week 0 through Week 52 | |
| Secondary | Acceptability of Weekly Doxycycline Prophylaxis | Week 4, 13, 26, 39 and 52 | The acceptability Likert scale has the following response options: Very acceptable/ Somewhat acceptable/ Neither acceptable nor unacceptable/ Somewhat unacceptable/ Very unacceptable/ Prefer not to answer |
| Secondary | Adherence to Weekly Doxycycline Prophylaxis | Up to 52 weeks. | Number of directly observed doses |
| Secondary | Number of Tetracycline-resistant isolates for CT | Week 0, Week 26 and Week 52. | Summarized by Randomized Study Arm |
| Secondary | Number of Tetracycline-resistant isolates for NG | Week 0, Week 26 and Week 52. | Summarized by Randomized Study Arm |
| Secondary | Number of Tetracycline resistant isolates of M. genitalium | Week 0, Week 26 and Week 52 | Summarized by Randomized Study Arm |
| Secondary | Number of Tetracycline resistant isolates of S. aureus | Week 0, Week 26 and Week 52. | Summarized by Randomized Study Arm |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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