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Trial · NCT05991622

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryRecruitment rates6 months
percent of patients interested in the treatment, patient eligibility rate, consent rate, rate of recruitment, percent of participants who initiate injectables, follow-up completion rate (through 6 months), and reasons for refusal
PrimaryAcceptability6 monthsstudy dropout rate (those who were lost to follow-up) and rate of discontinuation of injectables (those who decided to transition back to oral/sublingual regimen) as indices of
PrimaryFeasibility/Acceptability6 monthsClient Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services
PrimarySelf-report of engagement in treatment6 months
Treatment Effectiveness Assessment : elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains -- substance use, health, lifestyle, community,
PrimaryFeasibility/Acceptability6 months
Qualitative interviews to explore the acceptability and feasibility of the intervention format (e.g. processes and procedures, access to support services, tolerability of medication) and how the intervention could be strengthened, identifying areas needing refinement or improvement for future iterations.
SecondarySubstance use6 monthsNational Epidemiologic Survey on Alcohol and Related Conditions (NESARC)
SecondarySubstance use6 monthsNIDA-modified ASSIST - tool to identify risky substance use
SecondarySubstance use6 monthsurine drug screens from the individual's electronic medical record
SecondaryHIV Risk Behavior6 monthsTexas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior
SecondaryTreatment services6 months
Treatment Services Review will be used to assess receipt of case management, psychiatric, peer recovery coaching, and other treatment services, including utilization of other medications for OUD (e.g., if a participant has transitioned to Methadone).
SecondaryOverall Quality of life6 months
Q-LES-Q-SF, a psychometrically sound shorter version of the original Q-LES-Q. It consists of a self-reported 16-item questionnaire that has shown internal consistency, rest-retest reliability, and convergent and criterion validity (80% sensitivity, 100% specificity)

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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