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Trial · NCT07901101

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean Acceptability Score on the RAPID Response Acceptability QuestionnaireDay 0 (before emergency department discharge)
Mean of 14 items based on the Theoretical Framework of Acceptability (TFA), each rated 1 (strongly disagree) to 5 (strongly agree). Possible range 1-5; higher scores mean greater acceptability of starting PrEP in the emergency department.
SecondaryMean Acceptability Score at Follow-up48-72 hours, 30 days, 60 days, 90 days and 365 days after dischargeSame 14-item TFA-based score (range 1-5; higher = greater acceptability), reported separately at each timepoint.
SecondaryPercentage of Approached Patients Who EnrollThroughout enrollment, up to 6 monthsNumber of patients who consent divided by the number of patients aged 18 or older approached by the peer navigator, as a percentage.
SecondaryNumber of Participants Who Take the First PrEP DoseUp to 72 hours after dischargeCount of enrolled participants whose first dose is observed in the emergency department or, by exception, by video or in person within 72 hours
SecondaryPercentage of Participants Linked to PrEP Care at 30 Days30 days after dischargePercentage of participants who attend a visit with a community PrEP provider within 30 days of discharge, confirmed by the navigator.
SecondaryPercentage of Participants Linked to PrEP Care at 90 Days90 days after dischargePercentage of participants with a confirmed visit with an ongoing PrEP provider by 90 days.
SecondaryPercentage of Participants Still Taking PrEP90 days and 365 days after dischargePercentage of participants who report taking PrEP at the time of contact.
SecondaryPercentage of Participants With Follow-up PrEP Laboratory Testing120 days after dischargePercentage of participants whose outside PrEP provider confirms follow-up PrEP labs and a PrEP prescription.
SecondaryChange in PrEP Knowledge ScoreDay 0, before and after educationNumber correct on a 9-item true/false PrEP knowledge check (range 0-9; higher = more knowledge), after education minus before education.
SecondaryNumber of Participants With a New HIV Diagnosis After Starting PrEPUp to 365 days after dischargeCount of participants with a positive HIV result after the first dose, including a positive confirmatory HIV-1 RNA test after discharge.
SecondaryNumber of Participants Who Stop PrEP Because of Side EffectsUp to 365 days after dischargeCount of participants who report stopping PrEP because of side effects.
SecondaryTime From Navigator Contact to First PrEP DoseDay 0Median minutes from the navigator's first bedside contact to the observed first dose.

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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