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Integrating Depression Care Into HIV Services for Older People With HIV Using a Stepped Care, Task-Sharing Approach.

NCT06894680 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-22

No results posted yet for this study

Summary

Depression levels will be compared using PHQ-9 in the Treatment as Usual arm(TAU) VS intervention arm to see if the stepped care intervention is effective in treating depression. The main questions it aims to answer are:

* Needs assessment of stepped-care integration versus usual care for treating depression in older adults living with HIV?
* How effective will the stepped care task-sharing (SCT) model in reducing depressive symptoms and improving HIV treatment outcomes in older PLHIV in Nigeria? Participants who screen positive for depression PHQ-9 ≥10 will be randomized into 2 arms for treatment using a systemized ballot system: TAU arm and Intervention arm.

TAU arm will receive current treatment available for depression at the HIV center.

Intervention arm will receive the stepped-care intervention in stages based on their symptom severity.

Follow-up assessments at (6 weeks, 3months and 6 months) will be conducted by assessors who would be blinded to the different groups (TAU arm VS intervention arm).

Conditions

Interventions

OTHER

Stepped care

It is a systematic, staged approach to delivering care based on the severity of a condition and the patient's response to treatment. In this model, less intensive interventions are provided first, and only those who do not improve progress to more intensive treatments. In clinical research, stepped-care is classified as an adaptive intervention, where treatment is adjusted based on pre-specified criteria, making it patient-centered and resource-efficient.

OTHER

Treatment as usual

Clients that are considered to be depressed are offered counselling by the Nurses who are the first point of contact. Depending on the severity of symptoms the client are then referred to the medical officer at the HIV clinic for assessment and offered counselling services by the counsellors. if symptoms are severe and considered to need specialist care the medical officer will refer to a specialist(psychiatrist) outside the HIV care facility.

Sponsors & Collaborators

  • Royal Society of Tropical Medicine and Hygiene

    lead OTHER

Principal Investigators

  • Olufisayo O Elugbadebo, MBBS, Msc · Department of Psychiatry, College of Medicine, University of Ibadan, Nigeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-12-31
Completion
2026-03-24

Countries

  • Nigeria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894680 on ClinicalTrials.gov