Table 1 HIV + D outcome measures and specific outcomes
Outcome | Source of data | Endpoint | |
|---|---|---|---|
Collected at 3 months | Collected at 12 months | ||
Primary outcome | |||
Mean DD symptom severity scores | PHQ-9 [41] | √ | |
Secondary outcomes | |||
Mean DD symptom severity scores | PHQ-9 [41] | √ | |
Remission (proportion with PHQ-9 scores < 5) | PHQ-9 [41] | √ | √ |
Mean generalised anxiety disorder (GAD) severity scores | GAD-7 [47] | √ | √ |
Quality adjusted life years (QALYs) | EQ-5D-5 L [48] | √ | √ |
Days out of work (over 3 months) | Patient cost questionnaire | √ | √ |
Functional impairment and welfare | OxCAP-MH [49] | √ | √ |
Patients’ satisfaction with depression care | Modified Patient Satisfaction Survey by Ede et al. [50] | √ | |
Carers’ perceptions and satisfaction levels with integration efforts at HIV clinic | Modified Staff Survey by Ede et al. [50] | √ | |
Proportion with virological failure (a proxy measure of adherence; defined as a viral load of 400 copies/ml or more) | HIV viral load (copies/ml) | √ | |
Reported adherence to ART (proportion of participants who have missed at least one dose of ART in the past three days compared against the baseline value) | Assessed by means of the question, ‘Have you missed taking ART in the last 3 days?’ Possible responses 1 = Yes, 2 = No | √ | √ |