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

NCT06894680 | Active Not Recruiting DMC

• 2 other identifiers: SC-Depression-HIV-Ibadan-2025NIhr24156
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Older Adults (50-90 Years); Depression

Keywords

Stepped-care approach; HIV and mental health; Older adults living with HIV(PLHIV); Depression care; Implementation research

Outcome Measures

Primary Outcomes (1)

• Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by PHQ-9.

  This outcome will determine whether the Stepped care task-sharing approach provides greater symptom relief compared to usual treatment and supports its potential integration into routine HIV treatment and support service.

  Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Participants in the Treatment as Usual arm will receive the routine care available for people living with HIV with depression at the health facility.

Other: Treatment as usual

Intervention arm

EXPERIMENTAL

Step 1 at baseline PHQ-9 ≥10-14: Psychosocial intervention (PI) only for 6 weeks. PHQ-9 ≥15: supervising psychiatrist review + anti-depressants(sertraline) + PI for 6 weeks. At 6 weeks assessment, if PHQ-9 is ≥10; proceed to step 2. Others with PHQ\<10: Continue bi-weekly PI to complete 3rd \& 6th month assessment. Step 2 1. PHQ-9 ≥10 (without previous antidepressant); supervising psychiatrist review + antidepressants + weekly PI for 6 weeks (to complete 3rd month assessment). 2. PHQ-9 ≥10 (with previous antidepressant use); supervising psychiatrist to review medication + weekly PI for 6 weeks. At reassessment (3rd month assessment) if PHQ-9 ≥10; proceed to step 3. Others with PHQ\<10 at 3rd month assessment: Continue bi-weekly follow-up and complete 6-month assessment. Step 3: PHQ-9 ≥10; supervising psychiatrist review every 6 weeks +antidepressant+ 2 PI per week At reassessment, participants with no improvement (PHQ-9 ≥10) ; refer to psychiatrist.

Other: Stepped care

Interventions

Stepped care OTHER

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.

Intervention arm

Treatment as usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting individuals living with HIV
• People living with HIV who are 50 years and above (PLHIV aged ≥50 years)
• Those with a score of ≥10 on the 9-item patient-health questionnaire (PHQ-9).

You may not qualify if:

• Older PLHIV will be assessed for the imminent risk of suicide and if there is an high risk, participant will be excluded.
• Older PLHIV with severe cognitive impairment or diagnosed dementia that limits their ability to provide informed consent or complete study visits will be excluded.
• Participants with comorbidities that can preclude the use of sertraline should be excluded.

Sponsors & Collaborators

• Royal Society of Tropical Medicine and Hygiene: lead

Study Sites (1)

Institute of Infectious Diseases

Ibadan, Oyo State, 200212, Nigeria

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Olufisayo O Elugbadebo, MBBS, Msc

  Department of Psychiatry, College of Medicine, University of Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 24, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 24, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)