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Trial · NCT03275350

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed12 weeks and 24 weeksHIV-1 RNA \<200 copies/ml
PrimaryNumber of Participants With HIV Viral Suppression, Complete Case12 weeks and 24 weeksHIV-1 RNA \<200 copies/ml
PrimaryNumber of Participants With HIV Viral Suppression, Per-protocol12 weeks and 24 weeksHIV-1 RNA \<200 copies/ml
SecondaryVeterans Aging Cohort Study (VACS) IndexBaseline and 24 weeksAbsolute value of participant VACS Index at baseline and 24 weeks Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.
SecondaryCD4 CountBaseline and 24 weeksCluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.
SecondaryEngagement in HIV Care: Antiretroviral Therapy PrescribedBaseline and 24 weeks
Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.
SecondaryEngagement in HIV Care: 100% Antiretroviral Therapy Adherence24 weeks
Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.
SecondaryNumber of Participants With at Least 1 HIV Care Visit in Past 12 Weeks24 weeksAt least 1 HIV care visit in past 12 weeks
SecondaryNumber of Participants Who Had Unprotected Sex in Past 30 DaysBaseline and 24 weeksPast 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
SecondaryNumber of Participants With Multiple Sex Partners in Past 30 DaysBaseline and 24 weeksPast 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
SecondaryEngagement in HIV Care: Quality of LifeBaseline and 24 weeksPast 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24. Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome
SecondaryAverage Number of Self-Reported Days of Opioid Use in Last 30 DaysBetween baseline and 24 weeks
Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).
SecondaryNumber of Participants Who Test Positive for Opioids at 24 Weeks24 weeksNumber and percent of participants with UDS positive for opioids at 24 weeks.

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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