NCT07894042|Not Yet Recruiting
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Universitas Indonesia (BiSA Q1 High Impact EQUITY Program)
interventional
100
1 country
1
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Poor sleep is common among people living with HIV and is linked to fatigue, psychological distress and poorer adherence to antiretroviral therapy. This study develops a mobile sleep hygiene mentor that uses artificial intelligence to give personalised sleep recommendations, with a dashboard that lets nurses follow participants and respond to risks. The mentor is built with adults living with HIV and HIV nurses and then tested for usability and feasibility. In the main evaluation, about 70 adults living with HIV with poor sleep use the mentor daily for four weeks, with two online nurse sessions, and are followed up four weeks later. The study measures sleep quality, insomnia severity, depression, anxiety and stress, fatigue, adherence to antiretroviral therapy, technology acceptance, engagement and safety.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2026
Actual (reported)October 26, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in sleep quality
Change from baseline in the Pittsburgh Sleep Quality Index global score. Range 0 to 21; higher scores indicate poorer sleep quality.
Baseline (week 0) and week 8
Insomnia severity
Weeks 0 and 8
Depression
Weeks 0 and 8
Anxiety
Four weeks of daily use of the mobile sleep hygiene mentor with nurse oversight through a dashboard and two online nurse monitoring sessions (weeks 2 and 4).
A mobile application with a daily check-in of 5 to 10 minutes on sleep, daily habits, stress and the time antiretroviral medicine was taken. A machine learning model selects one to three recommendations a day from an expert-validated sleep hygiene library and explains why each was chosen. Educational modules cover sleep and HIV, a regular sleep schedule, the sleep environment, caffeine and alcohol, evening screen use, relaxation and worry management, and links between sleep, mood and adherence. Trained nurses monitor participants through a dashboard with rule-based alerts and hold two online sessions of 20 to 30 minutes in weeks 2 and 4. An optional online peer support group may be offered.
Faculty of Nursing, Universitas Indonesia
Depok, West Java, 16424, Indonesia
Hening Pujasari, PhD
Universitas Indonesia
First Submitted
October 18, 2026
First Posted
October 26, 2026
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Screen2Prevent (S2P)
Weeks 0 and 8
Stress
Weeks 0 and 8
Fatigue
Weeks 0 and 8
Contact the study team to confirm eligibility.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the published results will be shared.
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Source: ClinicalTrials.gov.
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