Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms

NCT07892534 | Not Yet Recruiting

• 2 other identifiers: FONUI-KET-128-2026PKS-154/UN2.R3/HKP.05.00/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insomnia; HIV Infections

Keywords

telenursing; sleep coaching; cognitive behavioural therapy for insomnia; feasibility study; co-design; Indonesia

Outcome Measures

Primary Outcomes (9)

• Recruitment rate

  Number of participants enrolled, expressed as a percentage of the target sample of 50.

  3 months from the start of recruitment

• Retention to the second baseline

  Percentage of enrolled participants who complete the second baseline assessment.

  Week 4

• Retention to follow-up

  Percentage of enrolled participants who complete the follow-up assessment.

  Week 11

• Session attendance

  Percentage of participants who attend at least 3 of the 4 coaching sessions.

  Weeks 4 to 7

• Sleep diary completion

  Percentage of participants who complete at least 5 of 7 sleep diary days at each assessment.

  Weeks 0, 4 and 11

• Questionnaire completion

  Percentage of questionnaires with complete data at each assessment.

  Weeks 0, 4 and 11

• Intervention fidelity

  Percentage of core session components delivered, recorded on coach fidelity checklists.

  Weeks 4 to 7

• Usability of the telenursing platform

  System Usability Scale total score. Range 0 to 100; higher scores indicate better usability.

  Week 11

• Number of participants with adverse events

  Number of participants with at least one adverse event, including events possibly related to the intervention.

  Weeks 4 to 11

Secondary Outcomes (10)

• Insomnia severity

  Weeks 0, 4 and 11

• Sleep quality

  Weeks 0, 4 and 11

• Sleep onset latency

  Weeks 0, 4 and 11

• Wake after sleep onset

  Weeks 0, 4 and 11

• Total sleep time

  Weeks 0, 4 and 11

Study Arms (1)

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.

Behavioral: Telenursing-based sleep coaching

Interventions

Telenursing-based sleep coaching BEHAVIORAL

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.

Also known as: Sleep coaching, Telenursing CBT-I

Telenursing-based sleep coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Indonesia: lead
• Kamuzu University of Health Sciences: collaborator
• Indonesian Endowment Fund for Education (LPDP): collaborator

Study Sites (1)

Faculty of Nursing, Universitas Indonesia

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; HIV Infections

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hening Pujasari, PhD

  Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hening Pujasari, PhD

CONTACT

+62 858 4844 7209; pujasari@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants complete two baseline assessments four weeks apart, then receive the intervention, then complete a follow-up assessment.

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the main findings.
• Access Criteria: Reasonable request to the corresponding author, subject to approval by the Ethics Review Committee, Faculty of Nursing, Universitas Indonesia.

Locations

ID (1)