Older Adults (50-90 Years)NCT06894680
Integrating Depression Care Into HIV Services for Older People With HIV Using a Stepped Care, Task-Sharing Approach.
A study testing Stepped care and Treatment as usual in people with Older Adults (50-90 Years) and Depression, run by Royal Society of Tropical Medicine and Hygiene at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Older Adults (50-90 Years), Depression
- What is being tested?
- Stepped care and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- 24 Mar 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Adaptation of a Stepped Care, Task-sharing Approach for Integrating Depression Care for Older People Living With HIV (PLHIV) Into HIV Treatment and Support Services in Ibadan, Nigeria.
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.
Read more
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, 6 months, 9 months and 12 months) will be conducted by assessors who would be blinded to the different groups (TAU arm VS intervention arm).
Read the detailed description
Depression is a common but often overlooked comorbidity among older adults living with HIV (PLHIV), particularly in low-resource settings. It negatively impacts health outcomes, adherence to antiretroviral therapy (ART), and overall quality of life. Despite its high prevalence, access to specialized mental health services remains limited due to workforce shortages and structural barriers within healthcare systems. A stepped-care task-sharing approach offers a potentially scalable solution by leveraging non-specialist healthcare workers to deliver evidence-based mental health interventions adapted from the WHO Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) for depression, including psychosocial interventions and antidepressant treatment according to symptom severity and treatment response, with brief psychological treatment delivered using the WHO Problem Management Plus guide, in a structured, stepwise manner. This study aims to evaluate the effectiveness of this approach in reducing depression among older PLHIV and assess its feasibility for broader implementation in Nigerian health facilities.
Study Objectives:
- Effectiveness Assessment: To determine whether integrating a stepped-care task-sharing approach into routine HIV care is more effective in reducing depression symptoms compared to usual treatment among older PLHIV.
- Implementation Feasibility: To identify facilitators and barriers to the successful adaptation and implementation of this intervention in local HIV facilities.
- Patient Outcomes \& Treatment Pathways: To evaluate the impact of the intervention on depression severity using the Patient Health Questionnaire-9 (PHQ-9) and examine how patients progress through different treatment steps based on symptom severity.
Study Design \& Methodology:
This is a randomized controlled trial (RCT) comparing a stepped-care task-sharing intervention to usual care in older PLHIV with depressive symptoms.
- Inclusion criteria:
- Older adults (≥50 years) living with HIV who screen positive for depression using PHQ-9.
- Randomization:
- Participants will be randomly assigned to either the intervention arm (stepped-care intervention) or the control arm (treatment as usual).
- Intervention Model:
- The intervention follows a stepped-care framework, where treatment intensity is adjusted based on depression severity at each stage.
Outcome Measures:
- Primary Outcome
- Reduction in depression severity as measured by PHQ-9 at 6 weeks, 3 months, 6 months, 9months and 12 months.
- Secondary Outcomes
- Acceptability of intervention.
- Barriers and facilitators to implementation (qualitative analysis).
- Changes in quality of life and HIV treatment adherence.
The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework will be used to evaluate effectiveness and implementation and will be measured using the following endpoints:
- Identify barriers and facilitators in adapting a stepped care task-sharing model for depression care. End point: Identify barriers and facilitators in adapting a stepped care task-sharing model for depression care. Effectiveness is determined by comparing: Primary Outcome: Reduction in PHQ-9 scores (depression severity). Secondary Outcomes: Adherence to psychosocial intervention sessions and medication. Secondary objectives:
- To compare the effectiveness of utilizing a stepped care task-sharing (SCT) model to usual treatment depression in older PLHIV in an HIV clinic in Nigeria.
Primary outcome: Rates of reduced depressive symptoms.
Secondary outcomes:
Assessing the rates of reduction in depressive symptoms from baseline to after intervention.
Significance of the Study This trial will provide evidence on the effectiveness and feasibility of integrating depression care within routine HIV services using a stepped-care, task-sharing model in Nigeria.
- Conditions
- Older Adults (50-90 Years), Depression
- Being tested
- Stepped care, Treatment as usual
- Keywords
- Stepped-care approach, HIV and mental health, Older adults living with HIV(PLHIV), Depression care, Implementation research
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped careOther
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.
Treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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, 9th \& 12th month assessment. Step 2 (a) PHQ-9 ≥10 (without previous antidepressant); supervising psychiatrist review + antidepressants + weekly PI for 6 weeks (to complete 3rd, 6, and 12th month assessment). (b) 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 6,9 and 12th month assessment. Step 3: PHQ-9 ≥10; supervising psychiatrist review every 6 weeks +antidepressant+ 2 PI per week At 3rd, 6th,9th and 12th month reassessment, participants with no improvement, refer Receives: Other: Stepped care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by Patient Health Questionnaire-9 (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. The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptoms, with scores ranging from 0 to 27. This outcome will determine whether the Stepped-Care Task-Sharing approach provides greater reduction in depressive symptoms compared with usual treatment and supports its potential integration into routine HIV treatment and support services.
Measured: Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start24 Mar 2025
- Primary completion28 Apr 2025
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (50-90 Years)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Society of Tropical Medicine and Hygiene
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OLUFISAYO ELUGBADEBO, Royal Society of Tropical Medicine and Hygiene
- Investigators
- Olufisayo O Elugbadebo, MBBS, Msc, Principal investigator, Department of Psychiatry, College of Medicine, University of Ibadan, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894680
- Sponsor's protocol ID
- SC-Depression-HIV-Ibadan-2025
- Other IDs
- NIhr24156
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adaptation of a Stepped Care, Task-sharing Approach for Integrating Depression Care for Older People Living With HIV (PLHIV) Into HIV Treatment and Support Services in Ibadan, Nigeria.
- ClinicalTrials.gov ID
- NCT06894680
- Acronym / sponsor ID
- SC-Depression-HIV-Ibadan-2025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Royal Society of Tropical Medicine and HygieneUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 25 Mar 2025 (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.
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, 6 months, 9 months and 12 months) will be conducted by assessors who would be blinded to the different groups (TAU arm VS intervention arm).
Detailed description
Depression is a common but often overlooked comorbidity among older adults living with HIV (PLHIV), particularly in low-resource settings. It negatively impacts health outcomes, adherence to antiretroviral therapy (ART), and overall quality of life. Despite its high prevalence, access to specialized mental health services remains limited due to workforce shortages and structural barriers within healthcare systems. A stepped-care task-sharing approach offers a potentially scalable solution by leveraging non-specialist healthcare workers to deliver evidence-based mental health interventions adapted from the WHO Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) for depression, including psychosocial interventions and antidepressant treatment according to symptom severity and treatment response, with brief psychological treatment delivered using the WHO Problem Management Plus guide, in a structured, stepwise manner. This study aims to evaluate the effectiveness of this approach in reducing depression among older PLHIV and assess its feasibility for broader implementation in Nigerian health facilities.
Study Objectives:
- Effectiveness Assessment: To determine whether integrating a stepped-care task-sharing approach into routine HIV care is more effective in reducing depression symptoms compared to usual treatment among older PLHIV.
- Implementation Feasibility: To identify facilitators and barriers to the successful adaptation and implementation of this intervention in local HIV facilities.
- Patient Outcomes \& Treatment Pathways: To evaluate the impact of the intervention on depression severity using the Patient Health Questionnaire-9 (PHQ-9) and examine how patients progress through different treatment steps based on symptom severity.
Study Design \& Methodology:
This is a randomized controlled trial (RCT) comparing a stepped-care task-sharing intervention to usual care in older PLHIV with depressive symptoms.
- Inclusion criteria:
- Older adults (≥50 years) living with HIV who screen positive for depression using PHQ-9.
- Randomization:
- Participants will be randomly assigned to either the intervention arm (stepped-care intervention) or the control arm (treatment as usual).
- Intervention Model:
- The intervention follows a stepped-care framework, where treatment intensity is adjusted based on depression severity at each stage.
Outcome Measures:
- Primary Outcome
- Reduction in depression severity as measured by PHQ-9 at 6 weeks, 3 months, 6 months, 9months and 12 months.
- Secondary Outcomes
- Acceptability of intervention.
- Barriers and facilitators to implementation (qualitative analysis).
- Changes in quality of life and HIV treatment adherence.
The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework will be used to evaluate effectiveness and implementation and will be measured using the following endpoints:
- Identify barriers and facilitators in adapting a stepped care task-sharing model for depression care. End point: Identify barriers and facilitators in adapting a stepped care task-sharing model for depression care. Effectiveness is determined by comparing: Primary Outcome: Reduction in PHQ-9 scores (depression severity). Secondary Outcomes: Adherence to psychosocial intervention sessions and medication. Secondary objectives:
- To compare the effectiveness of utilizing a stepped care task-sharing (SCT) model to usual treatment depression in older PLHIV in an HIV clinic in Nigeria.
Primary outcome: Rates of reduced depressive symptoms.
Secondary outcomes:
Assessing the rates of reduction in depressive symptoms from baseline to after intervention.
Significance of the Study This trial will provide evidence on the effectiveness and feasibility of integrating depression care within routine HIV services using a stepped-care, task-sharing model in Nigeria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment as usualParticipants in the Treatment as Usual arm will receive the routine care available for people living with HIV with depression at the health facility. |
| Intervention arm | Experimental | Other: Stepped careStep 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, 9th \& 12th month assessment. Step 2 (a) PHQ-9 ≥10 (without previous antidepressant); supervising psychiatrist review + antidepressants + weekly PI for 6 weeks (to complete 3rd, 6, and 12th month assessment). (b) 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 6,9 and 12th month assessment. Step 3: PHQ-9 ≥10; supervising psychiatrist review every 6 weeks +antidepressant+ 2 PI per week At 3rd, 6th,9th and 12th month reassessment, participants with no improvement, refer |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- • Older PLHIV will be assessed for the imminent risk of suicide and if there is an high risk, participant will be excluded.
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 |
|---|---|---|
| Stepped careIt 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 | Intervention arm |
| Treatment as usualClients 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. | Other | Treatment as Usual |
Primary outcome
Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months
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. The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptoms, with scores ranging from 0 to 27. This outcome will determine whether the Stepped-Care Task-Sharing approach provides greater reduction in depressive symptoms compared with usual treatment and supports its potential integration into routine HIV treatment and support services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Olufisayo O Elugbadebo, MBBS, Msc principal investigator
Department of Psychiatry, College of Medicine, University of Ibadan, Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped care and Treatment as usual in people with Older Adults (50-90 Years) and Depression, run by Royal Society of Tropical Medicine and Hygiene at 1 site in Nigeria.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 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 Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9). (time frame: Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months). 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 27 Oct 2026.