Table 4 Schema of patient-level data collection
Outcome | ||||||
|---|---|---|---|---|---|---|
Baseline | 6 months | 12 months | ||||
Outcome | Measurement | Source | Metric | |||
Primary measurements | ||||||
Depression symptoms | PHQ-9 | Self-reported | 50% reduction in PHQ-9 score | ●1 | ●●2 | ● |
Viral load suppression | Viral load value | Research- and programme-funded viral loads (latter through documentation during interviews and linkage to routine databases) | Viral load <1000 copies/ml | ● | ● | ●● |
Secondary mental health outcomes | ||||||
Depression symptoms | PHQ-9 | Self- reported | 50% reduction in PHQ-9 score | ● | ● | ●● |
Depression symptoms | PHQ-9 | Self- reported | Remission defined as score of <5 on PHQ-9 | ● | ● | ●● |
Depression symptoms | PHQ-9 | Self- reported | Mean PHQ-9 scores at 6 and 12 months | ● | ●● | ●● |
Depression symptoms | PHQ-9 | Self- reported | Category of depression: proportion with mild, moderate or severe depression | ● | ●● | ●● |
Antidepressant treatment | Self- reported | Proportion with antidepressant treatment initiated or intensified | ● | ● | ●● | |
Counselling | Self- reported | Proportion receiving counselling by clinic-based counsellor | ● | ● | ●● | |
Referral to specialist mental health worker/ service | Self- reported | Proportion referred | ● | ● | ●● | |
Stress | Perceived Stress Scale | Self-reported | Difference in means | ● | ●● | |
Secondary HIV measurements | ||||||
Viral load suppression | Viral load value | Research- and programme-funded viral loads | Viral load <400 copies/ml | ● | ● | ●● |
Virologic failure | Viral load values | Research- and programme-funded viral loads | Two consecutive viral load values >1000 copies/ml | ● | ● | ●● |
Change in viral load values over time | Viral load values | Research- and programme-funded viral loads | At least half a log difference between viral load values, unless there are two viral loads >2000 copies/ml | ● | ● | ●● |
ART treatment | ART regimen | Self-report | Clinically appropriate switches to second line ART therapy | ● | ●● | |
ART adherence | Visual Analogue Scale | Self-report | Difference in means | ● | ●● | |
Stigma | Internalised AIDS-Related Stigma Scale | Self-report | Difference in means | ● | ●● | |
Integrated care outcomes | ||||||
Cardiovascular risk factors | blood pressure, weight, body mass index, waist circumference | Interviewer measured | Difference in means | ● | ● | ●● |
Diagnosis of other comorbid illnesses | Self-reported | Proportion diagnosed | ● | ●● | ||
Disability | WHO Disability Assessment Schedule 2.0 | Self- reported | Difference in means | ● | ●● | |
Quality of chronic illness care received | Patient Assessment of Care for Chronic Conditions (PACIC) | Self-reported | Mean PACIC score | ● | ●● | |
Retention in care | Self-reported; clinic records | Proportion in care | ● | ●● | ||
Health economic outcomes | ||||||
Healthcare utilization | Self- reported; linkage with hospitalisation databases | Incidence rate ratio | ● | ●● | ||
Productivity and economic outcomes | Self- reported | ● | ●● | |||
Safety measurements | ||||||
Hospitalisation | Self- reported; linkage with hospitalisation databases | Proportion hospitalised | ● | ● | ●● | |
All-cause mortality | Clinic, report, linkage with mortality register | Proportion died | ● | ● | ●● | |
Suicide | Follow-up of cause of all known deaths with clinic and family interview | Proportion suicides | ● | ● | ●● | |