InsomniaNCT07892534
Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms
A study testing Telenursing-based sleep coaching in people with Insomnia and HIV Infections, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, HIV Infections
- What is being tested?
- Telenursing-based sleep coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2027to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living with HIV and currently receiving antiretroviral therapy
- Aged 18 years or older
- Insomnia symptoms: Pittsburgh Sleep Quality Index global score above 5 or a clinical complaint of insomnia confirmed at the screening interview
- Able to use a smartphone or other device for telenursing sessions
- Willing to take part in the programme for the duration of the study
- Provides written informed consent
Who cannot join
- Uncontrolled severe psychiatric disorder, such as psychosis or acute mania
- Neurological or physical condition that makes the programme unsuitable, such as dementia
- Sedative or hypnotic medicine started, or its dose changed, in the previous 4 weeks
- Severe sleep apnoea or another specific sleep disorder that requires different treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Faculty of Nursing, Universitas Indonesia
Depok, West Java, 16424
About this study
Official title: Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms in Indonesia: A Co-Design, Pilot and Double-Baseline Feasibility Study
Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia. This study develops a nurse-led sleep coaching programme based on CBT-I principles and delivered online (telenursing), and tests whether the programme and the study procedures are feasible. Fifty adults living with HIV who have insomnia symptoms will complete two baseline assessments four weeks apart, four weekly online coaching sessions and a follow-up assessment four weeks after the last session. The study measures recruitment, retention, attendance, adherence, data completeness, fidelity, usability and safety, and describes changes in sleep, fatigue, pain, anxiety and depression.
Read the detailed description
The study has three phases. In Phase 1, exploratory interviews explore the perceptions and needs of people living with HIV regarding telenursing-based sleep coaching, and people living with HIV, HIV counsellors and the research team then co-design the content, format and delivery of the programme in online workshops. In Phase 2, about 10 participants pilot the programme, and usability and acceptability are assessed with the System Usability Scale and interviews. This registration covers Phase 3, a single-arm feasibility study with a double baseline. Participants complete baseline 1 (T1), baseline 2 four weeks later with no intervention in between (T2), four weekly online sessions covering sleep education and sleep hygiene, cognitive restructuring and relaxation, stimulus control and sleep restriction, and maintenance, and a follow-up assessment four weeks after the last session (T3). The change between T1 and T2 describes the course of symptoms without intervention. Feasibility outcomes are compared with prespecified traffic light progression criteria to decide whether to proceed to a definitive trial. About 15 to 20 participants take part in qualitative interviews at follow-up.
- Conditions
- Insomnia, HIV Infections
- Being tested
- Telenursing-based sleep coaching
- Keywords
- telenursing, sleep coaching, cognitive behavioural therapy for insomnia, feasibility study, co-design, Indonesia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telenursing-based sleep coachingBehavioural
Also called Sleep coaching, Telenursing CBT-I
A nurse-led programme based on CBT-I principles, delivered by video call through a secure telenursing platform. Week 1: sleep education and sleep hygiene. Week 2: cognitive restructuring and relaxation. Week 3: stimulus control and sleep restriction. Week 4: maintenance and relapse prevention. Participants set weekly behavioural goals with their coach, keep a sleep diary and receive reminders between sessions. Content and format are finalised through co-design and a pilot.
| Study group | Role | What they receive |
|---|---|---|
| Telenursing-based sleep coaching | Experimental | Four weekly online sessions of 1 to 2 hours, delivered by nurse coaches and trained HIV counsellors, after a four-week period without intervention. Receives: Behavioral: Telenursing-based sleep coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants enrolled, expressed as a percentage of the target sample of 50.
Measured: 3 months from the start of recruitment
Retention to the second baseline
Percentage of enrolled participants who complete the second baseline assessment.
Measured: Week 4
Retention to follow-up
Percentage of enrolled participants who complete the follow-up assessment.
Measured: Week 11
Session attendance
Percentage of participants who attend at least 3 of the 4 coaching sessions.
Measured: Weeks 4 to 7
Sleep diary completion
Percentage of participants who complete at least 5 of 7 sleep diary days at each assessment.
Measured: Weeks 0, 4 and 11
Questionnaire completion
Percentage of questionnaires with complete data at each assessment.
Measured: Weeks 0, 4 and 11
Intervention fidelity
Percentage of core session components delivered, recorded on coach fidelity checklists.
Measured: Weeks 4 to 7
Usability of the telenursing platform
System Usability Scale total score. Range 0 to 100; higher scores indicate better usability.
Measured: Week 11
Number of participants with adverse events
Number of participants with at least one adverse event, including events possibly related to the intervention.
Measured: Weeks 4 to 11
Secondary outcomes (10)
Insomnia severity
Insomnia Severity Index total score. Range 0 to 28; higher scores indicate more severe insomnia.
Measured: Weeks 0, 4 and 11
Sleep quality
Pittsburgh Sleep Quality Index global score. Range 0 to 21; higher scores indicate poorer sleep quality.
Measured: Weeks 0, 4 and 11
Sleep onset latency
Mean time to fall asleep in minutes, from 7 days of the Consensus Sleep Diary.
Measured: Weeks 0, 4 and 11
Wake after sleep onset
Mean time awake after first falling asleep in minutes, from 7 days of the Consensus Sleep Diary.
Measured: Weeks 0, 4 and 11
Total sleep time
Mean total sleep time in minutes, from 7 days of the Consensus Sleep Diary.
Measured: Weeks 0, 4 and 11
Sleep efficiency
Mean sleep efficiency (total sleep time divided by time in bed, as a percentage), from 7 days of the Consensus Sleep Diary.
Measured: Weeks 0, 4 and 11
Fatigue
FACIT-Fatigue subscale score. Range 0 to 52; higher scores indicate less fatigue.
Measured: Weeks 0, 4 and 11
Pain intensity
Numeric Pain Rating Scale score. Range 0 to 10; higher scores indicate more severe pain.
Measured: Weeks 0, 4 and 11
Anxiety
Hospital Anxiety and Depression Scale anxiety subscale score. Range 0 to 21; higher scores indicate more anxiety.
Measured: Weeks 0, 4 and 11
Depression
Hospital Anxiety and Depression Scale depression subscale score. Range 0 to 21; higher scores indicate more depression.
Measured: Weeks 0, 4 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startApr 2027 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete two baseline assessments four weeks apart, then receive the intervention, then complete a follow-up assessment.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Indonesian Endowment Fund for Education (LPDP)
- Responsible party
- Sponsor
- Investigators
- Hening Pujasari, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892534
- Sponsor's protocol ID
- FONUI-KET-128-2026
- Other IDs
- PKS-154/UN2.R3/HKP.05.00/2025
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms in Indonesia: A Co-Design, Pilot and Double-Baseline Feasibility Study
- ClinicalTrials.gov ID
- NCT07892534
- Acronym / sponsor ID
- FONUI-KET-128-2026
- Conditions
- Insomnia, HIV Infections
- Keywords
- telenursing, sleep coaching, cognitive behavioural therapy for insomnia, feasibility study, co-design, Indonesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Indonesian Endowment Fund for Education (LPDP)
- Study start
- Apr 2027 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia. This study develops a nurse-led sleep coaching programme based on CBT-I principles and delivered online (telenursing), and tests whether the programme and the study procedures are feasible. Fifty adults living with HIV who have insomnia symptoms will complete two baseline assessments four weeks apart, four weekly online coaching sessions and a follow-up assessment four weeks after the last session. The study measures recruitment, retention, attendance, adherence, data completeness, fidelity, usability and safety, and describes changes in sleep, fatigue, pain, anxiety and depression.
Detailed description
The study has three phases. In Phase 1, exploratory interviews explore the perceptions and needs of people living with HIV regarding telenursing-based sleep coaching, and people living with HIV, HIV counsellors and the research team then co-design the content, format and delivery of the programme in online workshops. In Phase 2, about 10 participants pilot the programme, and usability and acceptability are assessed with the System Usability Scale and interviews. This registration covers Phase 3, a single-arm feasibility study with a double baseline. Participants complete baseline 1 (T1), baseline 2 four weeks later with no intervention in between (T2), four weekly online sessions covering sleep education and sleep hygiene, cognitive restructuring and relaxation, stimulus control and sleep restriction, and maintenance, and a follow-up assessment four weeks after the last session (T3). The change between T1 and T2 describes the course of symptoms without intervention. Feasibility outcomes are compared with prespecified traffic light progression criteria to decide whether to proceed to a definitive trial. About 15 to 20 participants take part in qualitative interviews at follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete two baseline assessments four weeks apart, then receive the intervention, then complete a follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| Telenursing-based sleep coaching | Experimental | Behavioral: Telenursing-based sleep coachingFour weekly online sessions of 1 to 2 hours, delivered by nurse coaches and trained HIV counsellors, after a four-week period without intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Living with HIV and currently receiving antiretroviral therapy
- Aged 18 years or older
- Insomnia symptoms: Pittsburgh Sleep Quality Index global score above 5 or a clinical complaint of insomnia confirmed at the screening interview
- Able to use a smartphone or other device for telenursing sessions
- Willing to take part in the programme for the duration of the study
Key exclusion criteria (4 listed)
- Uncontrolled severe psychiatric disorder, such as psychosis or acute mania
- Neurological or physical condition that makes the programme unsuitable, such as dementia
- Sedative or hypnotic medicine started, or its dose changed, in the previous 4 weeks
- Severe sleep apnoea or another specific sleep disorder that requires different treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telenursing-based sleep coachingAlso: Sleep coaching, Telenursing CBT-IA nurse-led programme based on CBT-I principles, delivered by video call through a secure telenursing platform. Week 1: sleep education and sleep hygiene. Week 2: cognitive restructuring and relaxation. Week 3: stimulus control and sleep restriction. Week 4: maintenance and relapse prevention. Participants set weekly behavioural goals with their coach, keep a sleep diary and receive reminders between sessions. Content and format are finalised through co-design and a pilot. | Behavioural | Telenursing-based sleep coaching |
Primary outcome
Recruitment rate
Time frame: 3 months from the start of recruitment
Number of participants enrolled, expressed as a percentage of the target sample of 50.
Retention to the second baseline
Time frame: Week 4
Percentage of enrolled participants who complete the second baseline assessment.
Retention to follow-up
Time frame: Week 11
Percentage of enrolled participants who complete the follow-up assessment.
Session attendance
Time frame: Weeks 4 to 7
Percentage of participants who attend at least 3 of the 4 coaching sessions.
Sleep diary completion
Time frame: Weeks 0, 4 and 11
Percentage of participants who complete at least 5 of 7 sleep diary days at each assessment.
Questionnaire completion
Time frame: Weeks 0, 4 and 11
Percentage of questionnaires with complete data at each assessment.
Intervention fidelity
Time frame: Weeks 4 to 7
Percentage of core session components delivered, recorded on coach fidelity checklists.
Usability of the telenursing platform
Time frame: Week 11
System Usability Scale total score. Range 0 to 100; higher scores indicate better usability.
Number of participants with adverse events
Time frame: Weeks 4 to 11
Number of participants with at least one adverse event, including events possibly related to the intervention.
10 secondary outcomes
Insomnia severity
Time frame: Weeks 0, 4 and 11
Sleep quality
Time frame: Weeks 0, 4 and 11
Sleep onset latency
Time frame: Weeks 0, 4 and 11
Wake after sleep onset
Time frame: Weeks 0, 4 and 11
Total sleep time
Time frame: Weeks 0, 4 and 11
Sleep efficiency
Time frame: Weeks 0, 4 and 11
Fatigue
Time frame: Weeks 0, 4 and 11
Pain intensity
Time frame: Weeks 0, 4 and 11
Anxiety
Time frame: Weeks 0, 4 and 11
Depression
Time frame: Weeks 0, 4 and 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hening Pujasari, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing-based sleep coaching in people with Insomnia and HIV Infections, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hening Pujasari, PhD (+62 858 4844 7209, pujasari@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 months from the start of recruitment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.