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Trial · NCT07894042

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryChange in sleep qualityBaseline (week 0) and week 8Change from baseline in the Pittsburgh Sleep Quality Index global score. Range 0 to 21; higher scores indicate poorer sleep quality.
SecondaryInsomnia severityWeeks 0 and 8Insomnia Severity Index total score. Range 0 to 28; higher scores indicate more severe insomnia.
SecondaryDepressionWeeks 0 and 8Depression subscale of the 21-item Depression Anxiety Stress Scales, multiplied by 2. Range 0 to 42; higher scores indicate more depression.
SecondaryAnxietyWeeks 0 and 8Anxiety subscale of the 21-item Depression Anxiety Stress Scales, multiplied by 2. Range 0 to 42; higher scores indicate more anxiety.
SecondaryStressWeeks 0 and 8Stress subscale of the 21-item Depression Anxiety Stress Scales, multiplied by 2. Range 0 to 42; higher scores indicate more stress.
SecondaryFatigueWeeks 0 and 8FACIT-Fatigue subscale score. Range 0 to 52; higher scores indicate less fatigue.
SecondaryAdherence to antiretroviral therapyWeeks 0 and 8Three-item self-report adherence scale for the past 30 days. Range 0 to 100; higher scores indicate better adherence.
SecondaryPerceived usefulness of the mentorWeeks 0 and 8Mean score of study-specific Technology Acceptance Model items on perceived usefulness, developed and validated in Cycle 1; higher scores indicate greater perceived usefulness.
SecondaryPerceived ease of use of the mentorWeeks 0 and 8Mean score of study-specific Technology Acceptance Model items on perceived ease of use, developed and validated in Cycle 1; higher scores indicate greater ease of use.
SecondaryHealth beliefs about sleepWeeks 0 and 8Mean score of study-specific Health Belief Model items on sleep, developed and validated in Cycle 1; higher scores indicate stronger beliefs supporting healthy sleep behaviour.
SecondaryUsability of the mentorWeek 4 (Cycle 2) and week 8 (Cycle 3)System Usability Scale total score. Range 0 to 100; higher scores indicate better usability.
SecondaryEngagement with the mentorWeeks 1 to 4Number of days with a completed daily check-in, from app usage logs.
SecondaryRecruitment rate3 months from the start of Cycle 3 recruitmentNumber of participants enrolled in Cycle 3, expressed as a percentage of the target sample of 70.
SecondaryRetention to follow-upWeek 8Percentage of enrolled Cycle 3 participants who complete the week 8 assessment.
SecondaryAttendance at nurse monitoring sessionsWeeks 2 and 4Percentage of participants who attend at least 1 of the 2 nurse monitoring sessions.
SecondaryNumber of participants with adverse eventsWeeks 0 to 8Number of participants with at least one adverse event, including events possibly related to the mentor.

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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