Integrating Depression Care Into HIV Services for Older People With HIV Using a Stepped Care, Tas… (NCT06894680) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Integrating Depression Care Into HIV Services for Older People With HIV Using a Stepped Care, Task-Sharing Approach.
Nigeria120 participantsStarted 2025-03-24
Plain-language 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).
Who can participate
Age range
50 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* • 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by PHQ-9.
Timeframe: Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months
Trial details
NCT IDNCT06894680
SponsorRoyal Society of Tropical Medicine and Hygiene