This pilot feasibility randomized controlled trial will test a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention for depression and anxiety among people living with HIV (PLHIV) in Peshawar, Pakistan. Fifty participants will be randomized to either receive six sessions of the adapted CBT delivered by trained HIV health workers or treatment as usual (TAU). The study will assess feasibility, acceptability, recruitment and retention rates, and preliminary clinical outcomes, to inform the development of a larger definitive trial.

This feasibility pilot trial aims to evaluate the acceptability and feasibility of a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention for PLHIV with comorbid depression or anxiety in Pakistan. The study will be conducted at the Family Care Centre (FCC), Hayatabad Medical Complex, Peshawar, which provides HIV diagnosis, registration, treatment, and adherence counselling.

Fifty eligible participants aged 18-65, living with HIV, and meeting the Hospital Anxiety and Depression Scale (HADS) thresholds will be randomized (1:1) to intervention or treatment as usual. The intervention group will receive six consecutive sessions of Ca-CBT, designed to improve depression, anxiety, adherence to ART, and functionality. Sessions will use culturally relevant materials, metaphors, and self-help tools, tailored for low-literacy populations. Delivery will be by HIV health workers trained and supervised under a cascade model.

Primary feasibility outcomes include recruitment, retention, completion of therapy sessions, fidelity of delivery, and acceptability. Secondary outcomes include changes in depression (HADS), functioning (WHODAS), internalized stigma, ART adherence self-efficacy, health-related quality of life (EQ-5D), and trauma symptoms. Assessments will occur at baseline, 8 weeks (post-intervention), and 12 weeks (follow-up).

The trial uses a randomized, single-blind (assessors) two-arm design. Recruitment will draw from the FCC registry of HIV patients. Sample size justification follows CONSORT guidelines for feasibility trials, with traffic-light progression criteria (stop/amend/go thresholds) for decision-making on a definitive trial.

This study will provide essential data on feasibility, acceptability, and preliminary clinical signals to inform a full-scale RCT evaluating culturally adapted CBT for PLHIV in Pakistan.

Inclusion Criteria:

• Adults aged 18-65 years.
• Pakistani nationals and residents.
• Confirmed HIV diagnosis (newly diagnosed or on ART within 1 month of diagnosis, or already on lifelong ART, according to UNAIDS HIV diagnostic standards).
• Meeting criteria for depression and anxiety: HADS subscale score >8 on both depression and anxiety, and total HADS score >15.
• HIV patients with comorbid conditions (e.g., Hepatitis, HCV) may be included if HIV is the primary condition.

Exclusion Criteria:

• Diagnosis of bipolar disorder, psychosis, or other severe mental illness according to ICD-11 or DSM-5-TR.
• Evidence of learning disability or severe substance use disorder (except nicotine).
• Currently receiving psychotherapy or antidepressant medication within the last 6 months.
• Current suicidality (per WHO mhGAP) or suicide attempt within the last 2 years.
• HIV-associated neurocognitive disorders (HAND) or severe complications of HIV preventing participation, as judged by treating physician.
• Living in the same household as another study participant (to prevent contamination between arms).

The Individual Participant Data (IPD) from this pilot feasibility trial will be shared with qualified researchers upon request. The dataset will include anonymized data on participant demographics, eligibility, baseline measures, outcome assessments (HADS, WHODAS, ISMI, HIV-ASES, etc.), and data related to the intervention (Ca-CBT or Treatment as Usual). The data sharing plan ensures that participant confidentiality is maintained in accordance with ethical standards, and the dataset will be accessible for further analyses related to mental health interventions for HIV-positive individuals.

Data sharing will also be contingent upon institutional approval and the availability of resources for analysis. Access will be governed by ethical review board policies to protect participant privacy and confidentiality.

he anonymized IPD will be made available within 6 months after the final study results have been published or upon completion of the trial's final analysis. The data will be shared for a minimum of 5 years after study completion for continued scientific exploration.

Researchers wishing to access the data will need to submit a request to the Principal Investigator or Study Coordinator. Data will be provided to individuals and institutions with ethical approval from an Institutional Review Board (IRB) or Ethics Committee (EC), ensuring adherence to all confidentiality and privacy guidelines. Access will be provided under terms of a data use agreement (DUA) to guarantee appropriate and responsible use of the data.

Assessors conducting outcome measurements will be blinded to treatment allocation (single-blind design). Randomization and allocation will be performed centrally by an independent researcher not involved in assessments or intervention delivery. Intervention therapists (HIV health workers) and participants will be aware of allocation due to the behavioral nature of the intervention. To reduce accidental unblinding, assessors will be trained to avoid discussing intervention content with participants and will document any instances where they suspect unblinding. Participant perceptions of allocation will be collected post-study to assess potential unblinding.