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

Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
The aim of this trial is to adapt, pilot test and evaluate the implementation and effectiveness of a stepped care task-sharing (SCT) model in comparison to usual care to reduce depression in older PLHIV in an HIV clinic in Nigeria. Researchers will compare depression levels using PHQ-9 amongst patients in the usual care arm VS intervention arm to see if the stepped care intervention is effective in treating depression. Participants will go through different stages of intervention according to depression severity: These assessments will be conducted during and after the intervention to measure its effectiveness. Participants will be screened for depression using Patient Health Questionnaire-9 (PHQ-9) and those who screen positive for depression PHQ-9 ≥10 will be randomized into two arms for treatment using a systemized ballot system into: i. Treatment as usual (TAU arm) ii. Intervention arm. For the TAU arm: Participants will receive current treatment available for depression at the HIV center while those in the intervention arm will receive the stepped-care intervention. Stepped-care Intervention for Intervention arm Step 1 at baseline: Participants who screen positive to depression (PHQ-9 ≥10) will receive intervention as follows: If PHQ-9 ≥10-14: Psychosocial intervention(PI) alone, using the MH-gap intervention guide for depression, will be administered by the Health care providers(HCP) for 6 weeks. If PHQ-9 ≥15: Participants will be assessed by the supervising psychiatrist, anti-depressants(sertraline) will be prescribed, in addition to PI for 6 weeks. HCPs would provide PI, monitor, provide reports, and refer participants testing positive for immediate emergency consultation during follow-up (suicide risk and detrimental effects of medication) to the supervising psychiatrist. At 6 weeks assessment, if PHQ-9 is ≥10; proceed to step 2. Others with PHQ\<10: Continue follow-up (bi-weekly PI) to complete the 3rd and 6th month assessment. Step 2 1. Participants with PHQ-9 ≥10 (without previous antidepressant medication); refer to supervising psychiatrist for review and prescription of antidepressants(sertraline) in addition to weekly PI for 6 weeks (to complete 3rd month assessment). 2. Participants with PHQ-9 ≥10 (with previous antidepressant use); supervising psychiatrist to review medication + weekly PI for 6 weeks. HCPs would provide PI, monitor, provide reports, and refer participants testing positive for immediate emergency consultation during follow-up (suicide risk and detrimental effects of medication) to the Psychiatrist. 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: Participants with PHQ-9 ≥10; supervising psychiatrist review every 6 weeks, continue antidepressants in addition to two times a week PI for 3months. HCPs would provide PI, monitor, provide reports, and refer participants testing positive for immediate emergency consultation during follow-up (suicide risk and detrimental effects of medication) to the Psychiatrist. At reassessment, participants with no improvement (PHQ-9 ≥10) or exacerbated symptoms; HCPs discontinue follow-up and refer to the Psychiatrist. 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).
Epistemonikos ID: 4e92e5ec6f2f853e8effdc2eb9ac574035253974
First added on: Mar 26, 2025