Trial · NCT03637660
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With a Serological Response by Month 6. | Day 1 to Day 180 | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion). |
| Secondary | Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Gender identity, sexual orientation, sexual partner, sex history in last 60 days |
| Secondary | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Sex history in last 60 days |
| Secondary | Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Highest level of education completed, stage of syphilis, prior syphilis history |
| Secondary | Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Years of formal education |
| Secondary | Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | Sex, Ethnicity, Race |
| Secondary | Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | Age |
| Secondary | The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Through Month 12 | Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window. |
| Secondary | The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Day 1 through Day 2 | Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported. |
| Secondary | Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection | Day 1 to Day 180 | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion). Serological response to therapy by Month 6 was examined among participants with and without HIV infection, |
| Secondary | Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12. | Through month 12 | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 12 visit window (i.e., seroreversion). |
| Secondary | Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection | Through month 12 | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 12visit window (i.e., seroreversion). Serological response to therapy by Month 12 was examined among participants with and without HIV infection, |
| Secondary | Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Through week 1 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire | Through week 2 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire | Through month 1 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire | Through month 3 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire | Through month 6 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire | Through month 9 | Sex history since last visit. |
| Secondary | Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire | Through month 12 | Sex history since last visit. |
| Secondary | Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Through week 1 | Sex history since last visit |
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.
For software
Read this list from software.
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